{ "FullStudy":{ "Rank":218037, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513551", "OrgStudyIdInfo":{ "OrgStudyId":"V114-002" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-004542-18", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"EudraCT Number" },{ "SecondaryId":"V114-002", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Merck Protocol Number" } ] }, "Organization":{ "OrgFullName":"Merck Sharp & Dohme Corp.", "OrgClass":"INDUSTRY" }, "BriefTitle":"The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)", "OfficialTitle":"A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and PREVNAR 13® (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or Older" }, "StatusModule":{ "StatusVerifiedDate":"November 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 13, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 15, 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 15, 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 27, 2011", "StudyFirstSubmitQCDate":"January 16, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"November 26, 2018", "ResultsFirstSubmitQCDate":"November 26, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"December 13, 2018", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"November 26, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 13, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Merck Sharp & Dohme Corp.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older.\n\nThe primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Pneumococcal Infections" ] }, "KeywordList":{ "Keyword":[ "Pneumococcal vaccines" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"692", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"V114", "ArmGroupType":"Experimental", "ArmGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Pneumococcal Conjugate Vaccine (V114)" ] } },{ "ArmGroupLabel":"PNEUMOVAX® 23", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: PNEUMOVAX® 23" ] } },{ "ArmGroupLabel":"PREVNAR 13®", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: PREVNAR 13®" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"Pneumococcal Conjugate Vaccine (V114)", "InterventionDescription":"15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "V114" ] } },{ "InterventionType":"Biological", "InterventionName":"PNEUMOVAX® 23", "InterventionDescription":"23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PNEUMOVAX® 23" ] } },{ "InterventionType":"Biological", "InterventionName":"PREVNAR 13®", "InterventionDescription":"13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PREVNAR 13®" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Participants With an Adverse Event", "PrimaryOutcomeDescription":"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.", "PrimaryOutcomeTimeFrame":"All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination" },{ "PrimaryOutcomeMeasure":"Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups", "PrimaryOutcomeDescription":"Injection-site AEs reported by >=2% of participants in one or more vaccination groups were assessed.", "PrimaryOutcomeTimeFrame":"Up to Day 14 postvaccination" },{ "PrimaryOutcomeMeasure":"Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups", "PrimaryOutcomeDescription":"Systemic AEs reported by >=2% of participants in one or more vaccination groups were assessed.", "PrimaryOutcomeTimeFrame":"Up to Day 14 postvaccination" },{ "PrimaryOutcomeMeasure":"Percentage of Participants With a Serious Adverse Event", "PrimaryOutcomeDescription":"A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.", "PrimaryOutcomeTimeFrame":"Up to 6 months postvaccination" },{ "PrimaryOutcomeMeasure":"Percentage of Participants With a Vaccine-related Serious Adverse Event", "PrimaryOutcomeDescription":"A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.", "PrimaryOutcomeTimeFrame":"Up to 6 months postvaccination" },{ "PrimaryOutcomeMeasure":"Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies", "PrimaryOutcomeDescription":"Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.", "PrimaryOutcomeTimeFrame":"One month postvaccination" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies", "SecondaryOutcomeDescription":"OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)", "SecondaryOutcomeTimeFrame":"One month postvaccination" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n-Without fever for 72 hours prior to vaccination\n\nExclusion Criteria:\n\nPrior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine\nKnown or suspected to be immunocompromised\nFunctional or anatomic asplenia\nHistory of autoimmune disease\nEvidence of dementia or cognitive impairment\nUse of any immunosuppressive therapy\nReceived a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine\nReceived a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine\nReceived any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine\nReceived a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine\nHistory of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease\nReceived antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"50 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Medical Director", "OverallOfficialAffiliation":"Merck Sharp & Dohme Corp.", "OverallOfficialRole":"Study Director" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"29559167", "ReferenceType":"derived", "ReferenceCitation":"Ermlich SJ, Andrews CP, Folkerth S, Rupp R, Greenberg D, McFetridge RD, Hartzel J, Marchese RD, Stek JE, Abeygunawardana C, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age. Vaccine. 2018 Oct 29;36(45):6875-6882. doi: 10.1016/j.vaccine.2018.03.012. Epub 2018 Mar 17." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Yes", "IPDSharingDescription":"https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf", "IPDSharingURL":"http://engagezone.msd.com/ds_documentation.php" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"This trial was conducted at 25 trial centers: 10 in the United States; 2 in Canada; 2 in Denmark; 2 in Israel; 2 in Norway, 3 in Poland, 2 in Spain and 2 in Sweden.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"V114", "FlowGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"PNEUMOVAX® 23", "FlowGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"PREVNAR 13®", "FlowGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"230" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"231" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"231" } ] } },{ "FlowMilestoneType":"Vaccinated", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"230" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"231" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"230" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"226" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"225" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"226" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"5" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"5" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Randomized but not vaccinated", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"The baseline analysis population consisted of all randomized participants who received study vaccine.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"V114", "BaselineGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"PNEUMOVAX® 23", "BaselineGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"PREVNAR 13®", "BaselineGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"230" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"231" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"230" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"691" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"50 to 64 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"79" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"80" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"80" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"239" } ] } } ] } },{ "BaselineClassTitle":"65 to 74 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"75" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"76" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"74" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"225" } ] } } ] } },{ "BaselineClassTitle":">= 75 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"76" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"75" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"76" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"227" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"122" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"123" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"122" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"367" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"108" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"108" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"108" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"324" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Ethnicity (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"48" } ] } },{ "BaselineCategoryTitle":"Not Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"216" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"211" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"215" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"642" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"14" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"2" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"28" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"212" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"217" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"212" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"641" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"5" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With an Adverse Event", "OutcomeMeasureDescription":"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.", "OutcomeMeasurePopulationDescription":"The analysis population consisted of those participants who received study vaccination and had safety follow-up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"V114", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PNEUMOVAX® 23", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PREVNAR 13®", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"229" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"230" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"230" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"75.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"68.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"65.7" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisStatisticalMethod":"Miettinen & Nurminen", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"6.8", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-1.4", "OutcomeAnalysisCIUpperLimit":"15.0" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisStatisticalMethod":"Miettinen & Nurminen", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"9.5", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.1", "OutcomeAnalysisCIUpperLimit":"17.7" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups", "OutcomeMeasureDescription":"Injection-site AEs reported by >=2% of participants in one or more vaccination groups were assessed.", "OutcomeMeasurePopulationDescription":"The analysis population consisted of those participants who received study vaccination and had safety follow-up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"Up to Day 14 postvaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"V114", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PNEUMOVAX® 23", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PREVNAR 13®", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"229" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"230" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"230" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Injection site erythema", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"13.0" } ] } } ] } },{ "OutcomeClassTitle":"Injection site induration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"12.6" } ] } } ] } },{ "OutcomeClassTitle":"Injection site pain", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"60.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"51.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"53.0" } ] } } ] } },{ "OutcomeClassTitle":"Injection site pruritus", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.2" } ] } } ] } },{ "OutcomeClassTitle":"Injection site swelling", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"18.3" } ] } } ] } },{ "OutcomeClassTitle":"Injection site warmth", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups", "OutcomeMeasureDescription":"Systemic AEs reported by >=2% of participants in one or more vaccination groups were assessed.", "OutcomeMeasurePopulationDescription":"The analysis population consisted of those participants who received study vaccination and had safety follow-up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"Up to Day 14 postvaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"V114", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PNEUMOVAX® 23", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PREVNAR 13®", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"229" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"230" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"230" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"48.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"43.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"45.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With a Serious Adverse Event", "OutcomeMeasureDescription":"A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.", "OutcomeMeasurePopulationDescription":"The analysis population consisted of those participants who received study vaccination and had safety follow-up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"Up to 6 months postvaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"V114", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PNEUMOVAX® 23", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PREVNAR 13®", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"229" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"230" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"230" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With a Vaccine-related Serious Adverse Event", "OutcomeMeasureDescription":"A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.", "OutcomeMeasurePopulationDescription":"The analysis population consisted of those participants who received study vaccination and had safety follow-up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"Up to 6 months postvaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"V114", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PNEUMOVAX® 23", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PREVNAR 13®", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"229" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"230" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"230" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies", "OutcomeMeasureDescription":"Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.", "OutcomeMeasurePopulationDescription":"The analysis population consisted of those participants who were not considered to have violated important protocol requirements that could have impacted the validity of the antibody response measured following vaccination.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"µg/mL", "OutcomeMeasureTimeFrame":"One month postvaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"V114", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PNEUMOVAX® 23", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"PREVNAR 13®", "OutcomeGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"210" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"207" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"212" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Serotype 1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.76", "OutcomeMeasurementLowerLimit":"3.05", "OutcomeMeasurementUpperLimit":"4.65" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.30", "OutcomeMeasurementLowerLimit":"2.68", "OutcomeMeasurementUpperLimit":"4.07" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.12", "OutcomeMeasurementLowerLimit":"2.54", "OutcomeMeasurementUpperLimit":"3.82" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.13", "OutcomeMeasurementLowerLimit":"0.96", "OutcomeMeasurementUpperLimit":"1.35" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.57", "OutcomeMeasurementLowerLimit":"0.47", "OutcomeMeasurementUpperLimit":"0.68" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.56", "OutcomeMeasurementLowerLimit":"0.47", "OutcomeMeasurementUpperLimit":"0.66" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.96", "OutcomeMeasurementLowerLimit":"1.59", "OutcomeMeasurementUpperLimit":"2.41" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.03", "OutcomeMeasurementLowerLimit":"0.83", "OutcomeMeasurementUpperLimit":"1.27" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.09", "OutcomeMeasurementLowerLimit":"1.70", "OutcomeMeasurementUpperLimit":"2.56" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 5", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.99", "OutcomeMeasurementLowerLimit":"3.23", "OutcomeMeasurementUpperLimit":"4.92" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.70", "OutcomeMeasurementLowerLimit":"2.21", "OutcomeMeasurementUpperLimit":"3.30" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.76", "OutcomeMeasurementLowerLimit":"2.21", "OutcomeMeasurementUpperLimit":"3.44" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 6A", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"209" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.88", "OutcomeMeasurementLowerLimit":"3.73", "OutcomeMeasurementUpperLimit":"6.39" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.14", "OutcomeMeasurementLowerLimit":"0.90", "OutcomeMeasurementUpperLimit":"1.43" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.86", "OutcomeMeasurementLowerLimit":"3.86", "OutcomeMeasurementUpperLimit":"6.13" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 6B", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.43", "OutcomeMeasurementLowerLimit":"4.11", "OutcomeMeasurementUpperLimit":"7.17" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.01", "OutcomeMeasurementLowerLimit":"1.58", "OutcomeMeasurementUpperLimit":"2.57" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.81", "OutcomeMeasurementLowerLimit":"2.19", "OutcomeMeasurementUpperLimit":"3.62" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 7F", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.59", "OutcomeMeasurementLowerLimit":"3.72", "OutcomeMeasurementUpperLimit":"5.66" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.74", "OutcomeMeasurementLowerLimit":"3.00", "OutcomeMeasurementUpperLimit":"4.65" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6.06", "OutcomeMeasurementLowerLimit":"4.91", "OutcomeMeasurementUpperLimit":"7.48" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 9V", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.05", "OutcomeMeasurementLowerLimit":"3.32", "OutcomeMeasurementUpperLimit":"4.93" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.72", "OutcomeMeasurementLowerLimit":"2.21", "OutcomeMeasurementUpperLimit":"3.36" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.41", "OutcomeMeasurementLowerLimit":"2.77", "OutcomeMeasurementUpperLimit":"4.20" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 14", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.56", "OutcomeMeasurementLowerLimit":"6.86", "OutcomeMeasurementUpperLimit":"10.69" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.13", "OutcomeMeasurementLowerLimit":"6.38", "OutcomeMeasurementUpperLimit":"10.36" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8.90", "OutcomeMeasurementLowerLimit":"7.08", "OutcomeMeasurementUpperLimit":"11.18" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 18C", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.00", "OutcomeMeasurementLowerLimit":"6.62", "OutcomeMeasurementUpperLimit":"9.68" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.66", "OutcomeMeasurementLowerLimit":"3.73", "OutcomeMeasurementUpperLimit":"5.82" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6.83", "OutcomeMeasurementLowerLimit":"5.68", "OutcomeMeasurementUpperLimit":"8.20" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 19A", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.36", "OutcomeMeasurementLowerLimit":"7.66", "OutcomeMeasurementUpperLimit":"11.44" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.99", "OutcomeMeasurementLowerLimit":"5.67", "OutcomeMeasurementUpperLimit":"8.61" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"11.36", "OutcomeMeasurementLowerLimit":"9.28", "OutcomeMeasurementUpperLimit":"13.92" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 19F", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.35", "OutcomeMeasurementLowerLimit":"2.67", "OutcomeMeasurementUpperLimit":"4.21" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.17", "OutcomeMeasurementLowerLimit":"3.32", "OutcomeMeasurementUpperLimit":"5.24" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.80", "OutcomeMeasurementLowerLimit":"3.81", "OutcomeMeasurementUpperLimit":"6.04" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 22F", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.21", "OutcomeMeasurementLowerLimit":"4.25", "OutcomeMeasurementUpperLimit":"6.39" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.98", "OutcomeMeasurementLowerLimit":"1.61", "OutcomeMeasurementUpperLimit":"2.44" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.38", "OutcomeMeasurementLowerLimit":"0.32", "OutcomeMeasurementUpperLimit":"0.44" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 23F", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.55", "OutcomeMeasurementLowerLimit":"4.33", "OutcomeMeasurementUpperLimit":"7.12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.82", "OutcomeMeasurementLowerLimit":"1.44", "OutcomeMeasurementUpperLimit":"2.30" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.41", "OutcomeMeasurementLowerLimit":"2.62", "OutcomeMeasurementUpperLimit":"4.43" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 33F", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"212" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11.56", "OutcomeMeasurementLowerLimit":"9.27", "OutcomeMeasurementUpperLimit":"14.40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.26", "OutcomeMeasurementLowerLimit":"6.52", "OutcomeMeasurementUpperLimit":"10.47" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.85", "OutcomeMeasurementLowerLimit":"0.70", "OutcomeMeasurementUpperLimit":"1.03" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies", "OutcomeMeasureDescription":"OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)", "OutcomeMeasurePopulationDescription":"The analysis population consisted of those participants who were not considered to have violated important protocol requirements that could have impacted the validity of the antibody response measured following vaccination.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Titer", "OutcomeMeasureTimeFrame":"One month postvaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"V114", "OutcomeGroupDescription":"Healthy adult 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"OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"210" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"595.16", "OutcomeMeasurementLowerLimit":"498.23", "OutcomeMeasurementUpperLimit":"710.95" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"313.83", "OutcomeMeasurementLowerLimit":"256.64", "OutcomeMeasurementUpperLimit":"383.76" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"256.76", "OutcomeMeasurementLowerLimit":"212.08", "OutcomeMeasurementUpperLimit":"310.85" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"209" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"206" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"211" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2875.79", "OutcomeMeasurementLowerLimit":"2215.61", "OutcomeMeasurementUpperLimit":"3732.69" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1099.88", "OutcomeMeasurementLowerLimit":"804.01", "OutcomeMeasurementUpperLimit":"1504.63" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3001.63", "OutcomeMeasurementLowerLimit":"2380.57", "OutcomeMeasurementUpperLimit":"3784.72" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 5", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"211" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"712.21", "OutcomeMeasurementLowerLimit":"537.78", "OutcomeMeasurementUpperLimit":"943.22" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"288.41", "OutcomeMeasurementLowerLimit":"210.03", "OutcomeMeasurementUpperLimit":"396.06" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"372.35", "OutcomeMeasurementLowerLimit":"271.76", "OutcomeMeasurementUpperLimit":"510.19" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 6A", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"201" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"211" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4216.34", "OutcomeMeasurementLowerLimit":"2977.07", "OutcomeMeasurementUpperLimit":"5971.49" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"490.60", "OutcomeMeasurementLowerLimit":"325.94", "OutcomeMeasurementUpperLimit":"738.44" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5251.47", "OutcomeMeasurementLowerLimit":"4114.87", "OutcomeMeasurementUpperLimit":"6702.00" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 6B", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"209" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"206" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"210" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6469.99", "OutcomeMeasurementLowerLimit":"4775.27", "OutcomeMeasurementUpperLimit":"8766.16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1630.20", "OutcomeMeasurementLowerLimit":"1174.34", "OutcomeMeasurementUpperLimit":"2263.03" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4207.86", "OutcomeMeasurementLowerLimit":"3212.46", "OutcomeMeasurementUpperLimit":"5511.70" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 7F", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"206" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"209" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5148.66", "OutcomeMeasurementLowerLimit":"4170.62", "OutcomeMeasurementUpperLimit":"6356.06" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3665.62", "OutcomeMeasurementLowerLimit":"2722.58", "OutcomeMeasurementUpperLimit":"4935.30" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7816.74", "OutcomeMeasurementLowerLimit":"6358.89", "OutcomeMeasurementUpperLimit":"9608.81" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 9V", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"208" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"205" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"208" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3024.34", "OutcomeMeasurementLowerLimit":"2338.72", "OutcomeMeasurementUpperLimit":"3910.96" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1674.44", "OutcomeMeasurementLowerLimit":"1252.72", "OutcomeMeasurementUpperLimit":"2238.12" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2471.10", "OutcomeMeasurementLowerLimit":"1882.58", "OutcomeMeasurementUpperLimit":"3243.60" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 14", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"207" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"209" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4352.27", "OutcomeMeasurementLowerLimit":"3374.62", "OutcomeMeasurementUpperLimit":"5613.15" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3572.27", "OutcomeMeasurementLowerLimit":"2667.12", "OutcomeMeasurementUpperLimit":"4784.61" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4478.38", "OutcomeMeasurementLowerLimit":"3647.04", "OutcomeMeasurementUpperLimit":"5499.22" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 18C", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"209" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"205" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"211" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4631.86", "OutcomeMeasurementLowerLimit":"3730.53", "OutcomeMeasurementUpperLimit":"5750.96" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2438.57", "OutcomeMeasurementLowerLimit":"1839.33", "OutcomeMeasurementUpperLimit":"3233.04" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3358.41", "OutcomeMeasurementLowerLimit":"2665.75", "OutcomeMeasurementUpperLimit":"4231.06" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 19A", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"210" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"206" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"211" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3391.18", "OutcomeMeasurementLowerLimit":"2755.18", "OutcomeMeasurementUpperLimit":"4174.00" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2682.65", "OutcomeMeasurementLowerLimit":"2095.62", "OutcomeMeasurementUpperLimit":"3434.12" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4186.28", "OutcomeMeasurementLowerLimit":"3421.20", "OutcomeMeasurementUpperLimit":"5122.46" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 19F", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"208" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"206" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"209" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1201.17", "OutcomeMeasurementLowerLimit":"906.20", "OutcomeMeasurementUpperLimit":"1592.15" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1581.60", "OutcomeMeasurementLowerLimit":"1211.55", "OutcomeMeasurementUpperLimit":"2064.67" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1946.04", "OutcomeMeasurementLowerLimit":"1547.41", "OutcomeMeasurementUpperLimit":"2447.35" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 22F", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"208" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"203" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"197" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8329.52", "OutcomeMeasurementLowerLimit":"6542.87", "OutcomeMeasurementUpperLimit":"10604.06" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4382.78", "OutcomeMeasurementLowerLimit":"3359.60", "OutcomeMeasurementUpperLimit":"5717.58" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"57.45", "OutcomeMeasurementLowerLimit":"37.29", "OutcomeMeasurementUpperLimit":"88.50" } ] } } ] } },{ "OutcomeClassTitle":"Serotype 23F", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"208" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"206" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"210" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", 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"OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31116.90", "OutcomeMeasurementLowerLimit":"24612.69", "OutcomeMeasurementUpperLimit":"39339.94" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"27560.15", "OutcomeMeasurementLowerLimit":"21471.19", "OutcomeMeasurementUpperLimit":"35375.88" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3129.94", "OutcomeMeasurementLowerLimit":"2441.58", "OutcomeMeasurementUpperLimit":"4012.38" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Up to 6 months postvaccination", "EventsDescription":"The at-risk population consisted of all participants who received study vaccination and had safety follow-up.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"V114", "EventGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"229", "EventGroupSeriousNumAffected":"4", "EventGroupSeriousNumAtRisk":"229", "EventGroupOtherNumAffected":"167", "EventGroupOtherNumAtRisk":"229" },{ "EventGroupId":"EG001", "EventGroupTitle":"PNEUMOVAX® 23", "EventGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.", "EventGroupDeathsNumAffected":"1", "EventGroupDeathsNumAtRisk":"230", "EventGroupSeriousNumAffected":"7", "EventGroupSeriousNumAtRisk":"230", "EventGroupOtherNumAffected":"149", "EventGroupOtherNumAtRisk":"230" },{ "EventGroupId":"EG002", "EventGroupTitle":"PREVNAR 13®", "EventGroupDescription":"Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"230", "EventGroupSeriousNumAffected":"5", "EventGroupSeriousNumAtRisk":"230", "EventGroupOtherNumAffected":"141", "EventGroupOtherNumAtRisk":"230" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Cardiac failure", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"229" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"230" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"230" } ] } },{ "SeriousEventTerm":"Coronary artery occlusion", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"229" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"230" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"230" } ] } },{ "SeriousEventTerm":"Myocardial infarction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"229" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"230" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"230" } ] } },{ "SeriousEventTerm":"Vertigo", "SeriousEventOrganSystem":"Ear and labyrinth disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"229" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"230" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"230" } ] } },{ "SeriousEventTerm":"Gastrointestinal disorder", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"229" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"230" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"230" } ] } },{ "SeriousEventTerm":"Death", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"229" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"230" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"230" } ] } },{ "SeriousEventTerm":"Cholecystitis", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"229" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"230" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"230" } ] } },{ "SeriousEventTerm":"Appendicitis", "SeriousEventOrganSystem":"Infections and infestations", 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