{ "FullStudy":{ "Rank":217951, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514708", "OrgStudyIdInfo":{ "OrgStudyId":"FLU11T12P" }, "Organization":{ "OrgFullName":"Adimmune Corporation", "OrgClass":"INDUSTRY" }, "BriefTitle":"The Safety and Immune Response to Influenza Vaccination in Pregnant Women", "OfficialTitle":"The Safety and Immune Response to Influenza Vaccination in Pregnant Women" }, "StatusModule":{ "StatusVerifiedDate":"December 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 12, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 16, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Adimmune Corporation", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the antibody response to the influenza vaccine (AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks post immunization in pregnant women in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96). Besides, the vaccine safety will also be evaluated." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Influenza" ] }, "KeywordList":{ "Keyword":[ "Influenza", "Vaccination", "Vaccine", "Pregnancy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"46", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: AdimFlu-S Influenza Vaccine" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"AdimFlu-S Influenza Vaccine", "InterventionDescription":"Suspension for injection", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer.", "PrimaryOutcomeDescription":"The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer. Immunogenicity profile will be assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period.", "PrimaryOutcomeTimeFrame":"Immunogenicity profile was assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period. Moreover, the HAI titer of the cord blood was also measured and compared with the maternal blood sample." } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The secondary endpoint is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S.", "SecondaryOutcomeDescription":"Safety outcomes include immediate reactions at the time of vaccination, solicited local and systemic reactions for 7 days, unsolicited adverse events until the first post-vaccination serum collected (Day 28), and serious adverse events and adverse events of special interest until 8 weeks after the delivery.", "SecondaryOutcomeTimeFrame":"The safety information is collected from the day of vaccination to 8 weeks after the delivery." } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPregnant female aged ≥ 18 years old.\nSubject is pregnant for at least 3 months, inclusive.\nSubject is willing and able to adhere to visit schedules and all study requirements.\nSubject has read and signed the study-specific informed consent.\n\nExclusion Criteria:\n\nSubject with previous complicated pregnancy or preterm delivery, spontaneous or medical abortion;\nSubject with history or concurrent high risk of dangerous gestation such as gestational diabetes mellitus (GDM), pregnant induced hypertension, or preeclampsia;\nSubject received any influenza vaccine within the previous 6 months;\nSubject has a history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study vaccine;\nSubject or her family has the history of Guillain-Barré Syndrome;\nSubject has current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;\nSubject with influenza-like illness as defined by the presence of fever (temperature over 38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;\nSubject receive any treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;\nSubject has immunodeficiency or is under immunosuppressive treatment.\nSubject received any vaccine within 1 week prior to study vaccination or expected to receive one within 1 week after study vaccination;\nSubject received any blood products, including immunoglobulin, in the past 3 months before consent;\nSubject has underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Female", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"National Taiwan University Hospital", "LocationCity":"Taipei", "LocationZip":"100", "LocationCountry":"Taiwan" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"23762229", "ReferenceType":"derived", "ReferenceCitation":"Lin SY, Wu ET, Lin CH, Shyu MK, Lee CN. The safety and immunogenicity of trivalent inactivated influenza vaccination: a study of maternal-cord blood pairs in Taiwan. PLoS One. 2013 Jun 6;8(6):e62983. doi: 10.1371/journal.pone.0062983. Print 2013." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M15943", "InterventionBrowseLeafName":"Vaccines", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000007251", "ConditionMeshTerm":"Influenza, Human" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009976", "ConditionAncestorTerm":"Orthomyxoviridae Infections" },{ "ConditionAncestorId":"D000012327", "ConditionAncestorTerm":"RNA Virus Infections" },{ "ConditionAncestorId":"D000014777", "ConditionAncestorTerm":"Virus Diseases" },{ "ConditionAncestorId":"D000012141", "ConditionAncestorTerm":"Respiratory Tract Infections" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8878", "ConditionBrowseLeafName":"Influenza, Human", "ConditionBrowseLeafAsFound":"Influenza", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11485", "ConditionBrowseLeafName":"Orthomyxoviridae Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16105", "ConditionBrowseLeafName":"Virus Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13732", "ConditionBrowseLeafName":"RNA Virus Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13561", "ConditionBrowseLeafName":"Respiratory Tract Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC02", "ConditionBrowseBranchName":"Viral Diseases" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" } ] } } } } } }