{ "FullStudy":{ "Rank":217567, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519713", "OrgStudyIdInfo":{ "OrgStudyId":"MTA76 (SFY12080)" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"U1111-1124-7479", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"WHO" } ] }, "Organization":{ "OrgFullName":"Sanofi", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects", "OfficialTitle":"Immunogenicity and Safety of a Single Dose of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects" }, "StatusModule":{ "StatusVerifiedDate":"May 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"April 4, 2013", "ResultsFirstSubmitQCDate":"May 22, 2013", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 28, 2013", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 22, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 28, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Sanofi Pasteur, a Sanofi Company", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This study is designed to assess the safety and immunogenicity of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) to support registration of the product in Japan.\n\nPrimary Objective:\n\nTo describe the seroprotection rate [% of subjects with serum bactericidal assay using baby rabbit complement (SBA-BR) ≥1:128] to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age\n\nSecondary Objectives:\n\nTo describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years of age\nTo describe the immune responses to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.", "DetailedDescription":"All participants will receive a single injection of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine on Day 0 and undergo immunogenicity assessment and safety monitoring post-vaccination." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Meningitis", "Meningococcal Meningitis", "Meningococcal Infections" ] }, "KeywordList":{ "Keyword":[ "Meningitis", "Meningococcal Meningitis", "Meningococcal Infections", "Meningococcal conjugate Vaccine", "Menactra®" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"200", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Adults Study Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Meningococcal polysaccharide diphtheria toxoid conjugate" ] } },{ "ArmGroupLabel":"Adolescents Study Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Meningococcal polysaccharide diphtheria toxoid conjugate" ] } },{ "ArmGroupLabel":"Children Study Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Meningococcal polysaccharide diphtheria toxoid conjugate" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"Meningococcal polysaccharide diphtheria toxoid conjugate", "InterventionDescription":"0.5 mL, Intramuscular", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Adolescents Study Group", "Adults Study Group", "Children Study Group" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Menactra®, SP284" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine", "PrimaryOutcomeDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.", "PrimaryOutcomeTimeFrame":"28 Days post-vaccination" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine", "SecondaryOutcomeDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).", "SecondaryOutcomeTimeFrame":"28 Days post-vaccination" },{ "SecondaryOutcomeMeasure":"Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.", "SecondaryOutcomeDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).", "SecondaryOutcomeTimeFrame":"28 Days post-vaccination" },{ "SecondaryOutcomeMeasure":"Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine", "SecondaryOutcomeDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).", "SecondaryOutcomeTimeFrame":"Days 0 and 28 post-vaccination" },{ "SecondaryOutcomeMeasure":"Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine", "SecondaryOutcomeDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).", "SecondaryOutcomeTimeFrame":"28 Days post-vaccination" },{ "SecondaryOutcomeMeasure":"Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine", "SecondaryOutcomeDescription":"Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.\n\nGrade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities.", "SecondaryOutcomeTimeFrame":"Day 0 up to Day 28 post-vaccination" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAged 2 through 55 years on the day of inclusion\nFor subjects ≥ 20 years of age: Informed consent form has been signed and dated by the subjects. For subjects 2 to 19 years of age: Informed consent form has been signed and dated by the parent(s) or other legal representative. Also subjects 7 to 11 years of age will provide assent and subjects 12 to 19 years of age will provide written assent form.\nAble to attend all scheduled visits and to comply with all trial procedures\nFor a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.\n\nExclusion Criteria:\n\nAny acute and/or serious disease/illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion\nHistory of meningococcal diseases, confirmed either clinically, serologically, or microbiologically\nKnown systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine\nKnown or suspected congenital or current/ previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\nParticipation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion\nPlanned participation in another clinical trial during the present trial period\nReceipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response\nReceipt of any vaccine within the four weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine\nPlanned receipt of any vaccine during the trial period\nClinical or known serological evidence of systemic illness including hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) infection\nIneligible according to the investigator's clinical judgment\nKnown pregnancy, or suspected pregnancy or a positive (serum and/or urine) pregnancy test\nCurrently breast feeding a child\nKnown thrombocytopenia, contraindicating intramuscular (IM) vaccination\nBleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination\nDeprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily\nCurrent alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures\nIdentified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator\nPrevious vaccination against meningococcal disease with either the trial vaccine or another vaccine\nHistory of Guillain-Barré Syndrome.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"2 Years", "MaximumAge":"55 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Medical Director", "OverallOfficialAffiliation":"Sanofi Aventis K.K.", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Nagoya City", "LocationState":"Aichi", "LocationCountry":"Japan" },{ "LocationCity":"Osaka City", "LocationState":"Osaka", "LocationCountry":"Japan" },{ "LocationCity":"Shinjuku", "LocationState":"Tokyo", "LocationCountry":"Japan" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Related Info", "SeeAlsoLinkURL":"http://www.sanofipasteur.com" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"A total of 200 subjects who met the inclusion, but no exclusion criteria were enrolled and vaccinated.", "FlowRecruitmentDetails":"Study participants were enrolled from 20 January through 25 February 2012 in 4 clinic sites in Japan.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Adults Menactra® Vaccine Group", "FlowGroupDescription":"Participants aged 18 to 55 years received a single dose of Menactra® vaccine" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Adolescents Menactra® Vaccine Group", "FlowGroupDescription":"Participants aged 11 to 17 years received a single dose of Menactra® vaccine" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Children Menactra® Vaccine Group", "FlowGroupDescription":"Participants aged 2 to 10 years received a single dose of Menactra® vaccine" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"194" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"4" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"194" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"4" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Adults Menactra® Vaccine Group", "BaselineGroupDescription":"Participants aged 18 to 55 years received a single dose of Menactra® vaccine" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Adolescents Menactra® Vaccine Group", "BaselineGroupDescription":"Participants aged 11 to 17 years received a single dose of Menactra® vaccine" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Children Menactra® Vaccine Group", "BaselineGroupDescription":"Participants aged 2 to 10 years received a single dose of Menactra® vaccine" },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"194" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"2" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"4" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"200" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"6" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"194" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"194" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"35.6", "BaselineMeasurementSpread":"11.2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"11.0", "BaselineMeasurementSpread":"0.0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4.3", "BaselineMeasurementSpread":"2.6" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"34.7", "BaselineMeasurementSpread":"12.1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"97" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"99" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"97" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"101" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Japan", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"194" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"200" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine", "OutcomeMeasureDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.", "OutcomeMeasurePopulationDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"28 Days post-vaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Adults Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 18 to 55 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Adolescents Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 11 to 17 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Children Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 2 to 10 years received a single dose of Menactra® vaccine" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"194" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"4" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Serogroup A (N = 194, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"177" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup C (N = 192, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"154" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup Y (N = 192, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"180" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup W-135 (N = 193, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"172" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine", "OutcomeMeasureDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).", "OutcomeMeasurePopulationDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"28 Days post-vaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Adults Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 18 to 55 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Adolescents Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 11 to 17 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Children Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 2 to 10 years received a single dose of Menactra® vaccine" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"194" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"4" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Serogroup A (N = 194, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"180" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup C (N = 192, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"167" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup Y (N = 192, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"190" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup W-135 (N = 193, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"186" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.", "OutcomeMeasureDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).", "OutcomeMeasurePopulationDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"28 Days post-vaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Adults Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 18 to 55 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Adolescents Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 11 to 17 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Children Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 2 to 10 years received a single dose of Menactra® vaccine" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"194" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"4" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Serogroup A (N = 193, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"150" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup C (N = 191, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"151" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup Y (N = 191, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"139" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup W-135 (N = 192, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"169" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine", "OutcomeMeasureDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).", "OutcomeMeasurePopulationDescription":"Geometric mean titers of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Titers", "OutcomeMeasureTimeFrame":"Days 0 and 28 post-vaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Adults Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 18 to 55 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Adolescents Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 11 to 17 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Children Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 2 to 10 years received a single dose of Menactra® vaccine" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"194" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"4" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Serogroup A (Day 0; N = 193, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"26.0", "OutcomeMeasurementLowerLimit":"17.4", "OutcomeMeasurementUpperLimit":"38.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Data was not computable, variance was zero because all participants had the same value." },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Data was not computable, variance was zero because all participants had the same value." } ] } } ] } },{ "OutcomeClassTitle":"Serogroup A (Day 28; N = 194, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1202.6", "OutcomeMeasurementLowerLimit":"876.2", "OutcomeMeasurementUpperLimit":"1650.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2896.3", "OutcomeMeasurementLowerLimit":"35.4", "OutcomeMeasurementUpperLimit":"236766.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"16384.0", "OutcomeMeasurementLowerLimit":"1804.7", "OutcomeMeasurementUpperLimit":"148741.4" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup C (Day 0; N = 193, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.6", "OutcomeMeasurementLowerLimit":"4.2", "OutcomeMeasurementUpperLimit":"7.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Data was not computable, variance was zero because all participants had the same value." },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5.7", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"154.7" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup C (Day 28; N = 192, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"389.1", "OutcomeMeasurementLowerLimit":"274.4", "OutcomeMeasurementUpperLimit":"551.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2048.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"91459214176.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"512.0", "OutcomeMeasurementLowerLimit":"208.0", "OutcomeMeasurementUpperLimit":"1260.0" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup Y (Day 0; N = 193, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"64.2", "OutcomeMeasurementLowerLimit":"45.1", "OutcomeMeasurementUpperLimit":"91.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"181.0", "OutcomeMeasurementLowerLimit":"2.2", "OutcomeMeasurementUpperLimit":"14797.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"107.6", "OutcomeMeasurementLowerLimit":"26.9", "OutcomeMeasurementUpperLimit":"431.2" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup Y (Day 28; N = 192, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1244.4", "OutcomeMeasurementLowerLimit":"991.3", "OutcomeMeasurementUpperLimit":"1562.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"724.1", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"395556106.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3444.3", "OutcomeMeasurementLowerLimit":"298.5", "OutcomeMeasurementUpperLimit":"39740.1" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup W-135 (Day 0; N = 193, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12.8", "OutcomeMeasurementLowerLimit":"9.3", "OutcomeMeasurementUpperLimit":"17.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"128.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"855379.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"38.1", "OutcomeMeasurementLowerLimit":"1.4", "OutcomeMeasurementUpperLimit":"1025.1" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup W-135 (Day 28; N = 193, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"995.0", "OutcomeMeasurementLowerLimit":"737.9", "OutcomeMeasurementUpperLimit":"1341.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8192.0", "OutcomeMeasurementLowerLimit":"1.2", "OutcomeMeasurementUpperLimit":"54744273.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9742.0", "OutcomeMeasurementLowerLimit":"2431.7", "OutcomeMeasurementUpperLimit":"39028.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine", "OutcomeMeasureDescription":"Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).", "OutcomeMeasurePopulationDescription":"Geometric mean titer ratios of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Titers", "OutcomeMeasureTimeFrame":"28 Days post-vaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Adults Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 18 to 55 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Adolescents Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 11 to 17 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Children Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 2 to 10 years received a single dose of Menactra® vaccine" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"194" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"4" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Serogroup A (N = 193, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31.9", "OutcomeMeasurementLowerLimit":"21.7", "OutcomeMeasurementUpperLimit":"46.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"724.1", "OutcomeMeasurementLowerLimit":"8.9", "OutcomeMeasurementUpperLimit":"59191.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4096.0", "OutcomeMeasurementLowerLimit":"451.2", "OutcomeMeasurementUpperLimit":"37185.3" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup C (N = 191, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"40.8", "OutcomeMeasurementLowerLimit":"28.3", "OutcomeMeasurementUpperLimit":"58.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"512.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"22864803544.2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"53.8", "OutcomeMeasurementLowerLimit":"1.6", "OutcomeMeasurementUpperLimit":"1838.6" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup Y (N = 191, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16.1", "OutcomeMeasurementLowerLimit":"11.6", "OutcomeMeasurementUpperLimit":"22.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"26730.6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"32.0", "OutcomeMeasurementLowerLimit":"3.5", "OutcomeMeasurementUpperLimit":"290.5" } ] } } ] } },{ "OutcomeClassTitle":"Serogroup W-135 (N = 192, 2, 4)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"53.6", "OutcomeMeasurementLowerLimit":"38.9", "OutcomeMeasurementUpperLimit":"73.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"64.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Data was not computable, variance was zero because all participants had the same value." },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"215.3", "OutcomeMeasurementLowerLimit":"3.3", "OutcomeMeasurementUpperLimit":"13841.7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine", "OutcomeMeasureDescription":"Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.\n\nGrade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities.", "OutcomeMeasurePopulationDescription":"Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"Day 0 up to Day 28 post-vaccination", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Adults Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 18 to 55 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Adolescents Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 11 to 17 years received a single dose of Menactra® vaccine" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Children Menactra® Vaccine Group", "OutcomeGroupDescription":"Participants aged 2 to 10 years received a single dose of Menactra® vaccine" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"194" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"4" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Any injection site Pain", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"60" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Grade 3 injection site Pain", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Any injection site Erythema", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Grade 3 injection site Erythema", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Any injection site Swelling", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Grade 3 injection site Swelling", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Any Fever", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Grade 3 Fever", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Any Headache", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Grade 3 Headache", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Any Malaise", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Grade 3 Malaise", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Any Myalgia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"48" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } },{ "OutcomeClassTitle":"Grade 3 Myalgia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5.00", "EventsTimeFrame":"Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Adults Menactra® Vaccine Group", "EventGroupDescription":"Participants aged 18 to 55 years received a single dose of Menactra® vaccine", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"194", "EventGroupOtherNumAffected":"63", "EventGroupOtherNumAtRisk":"194" },{ "EventGroupId":"EG001", "EventGroupTitle":"Adolescents Menactra® Vaccine Group", "EventGroupDescription":"Participants aged 11 to 17 years received a single dose of Menactra® vaccine", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"2", "EventGroupOtherNumAffected":"2", "EventGroupOtherNumAtRisk":"2" },{ "EventGroupId":"EG002", "EventGroupTitle":"Children Menactra® Vaccine Group", "EventGroupDescription":"Participants aged 2 to 10 years received a single dose of Menactra® vaccine", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"4", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"4" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Injection site pain", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA 14.1", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"60", "OtherEventStatsNumAffected":"60", "OtherEventStatsNumAtRisk":"194" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"2" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"4" } ] } },{ "OtherEventTerm":"Injection site erythema", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA 14.1", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"194" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"2" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"4" } ] } },{ "OtherEventTerm":"Injection site swelling", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA 14.1", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"194" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"2" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"4" } ] } },{ "OtherEventTerm":"Malaise", "OtherEventOrganSystem":"General disorders", 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