Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-28 @ 7:54 AM
Study NCT ID:
NCT00389532
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2006-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUS@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi pasteur Inc'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 28 days post-vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Aged 18 to 59 Years', 'description': 'Participants aged 18 to 59 years at enrollment', 'otherNumAtRisk': 60, 'otherNumAffected': 15, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aged ≥ 60 Years', 'description': 'Participants aged 60 years and older at enrollment', 'otherNumAtRisk': 56, 'otherNumAffected': 2, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aged 18 to 59 Years', 'description': 'Participants aged 18 to 59 years at enrollment'}, {'id': 'OG001', 'title': 'Aged ≥ 60 Years', 'description': 'Participants aged 60 years and older at enrollment'}], 'classes': [{'title': 'Any Solicited Injection Site Reaction', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain (Incapacitating)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness (≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling (≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic Reaction', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (> 102.2°F)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (Prevented daily activities)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (Prevented daily activities)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (Prevented daily activities)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-3 days post-vaccination', 'description': 'Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was on all enrolled and vaccinated participants, Intend-to-treat population.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aged 18 to 59 Years', 'description': 'Participants aged 18 to 59 years at enrollment'}, {'id': 'OG001', 'title': 'Aged ≥ 60 Years', 'description': 'Participants aged 60 years and older at enrollment'}], 'classes': [{'title': 'H1N1 FLU A/NEW CALEDONIA/20/99 - PRE', 'categories': [{'measurements': [{'value': '66.2', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '105'}, {'value': '36.9', 'groupId': 'OG001', 'lowerLimit': '28.5', 'upperLimit': '47.7'}]}]}, {'title': 'H1N1 FLU A/NEW CALEDONIA/20/99 - POST', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000', 'lowerLimit': '151', 'upperLimit': '304'}, {'value': '77.0', 'groupId': 'OG001', 'lowerLimit': '57.9', 'upperLimit': '102'}]}]}, {'title': 'H3N2 FLU A/WISCONSIN/67/2005 - PRE', 'categories': [{'measurements': [{'value': '67.9', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '104'}, {'value': '110', 'groupId': 'OG001', 'lowerLimit': '70.8', 'upperLimit': '170'}]}]}, {'title': 'H3N2 FLU A/WISCONSIN/67/2005 - POST', 'categories': [{'measurements': [{'value': '453', 'groupId': 'OG000', 'lowerLimit': '334', 'upperLimit': '613'}, {'value': '513', 'groupId': 'OG001', 'lowerLimit': '363', 'upperLimit': '726'}]}]}, {'title': 'B FLU B/MALAYSIA SPLIT/2506/2004 - PRE', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '83.5', 'upperLimit': '165'}, {'value': '195', 'groupId': 'OG001', 'lowerLimit': '157', 'upperLimit': '241'}]}]}, {'title': 'B FLU B/MALAYSIA SPLIT/2506/2004 - POST', 'categories': [{'measurements': [{'value': '788', 'groupId': 'OG000', 'lowerLimit': '589', 'upperLimit': '1054'}, {'value': '597', 'groupId': 'OG001', 'lowerLimit': '477', 'upperLimit': '748'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '21 days post-vaccination', 'description': 'GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric Mean Titers were evaluated in the per-protocol immunogenicity Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aged 18 to 59 Years', 'description': 'Participants aged 18 to 59 years at enrollment'}, {'id': 'FG001', 'title': 'Aged ≥ 60 Years', 'description': 'Participants aged 60 years and older at enrollment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '3 of the participants did not have valid post-vaccination serological results', 'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were enrolled from October through December 2006 in 1 medical clinic in the US', 'preAssignmentDetails': 'A total of 116 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aged 18 to 59 Years', 'description': 'Participants aged 18 to 59 years at enrollment'}, {'id': 'BG001', 'title': 'Aged ≥ 60 Years', 'description': 'Participants aged 60 years and older at enrollment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '12.25', 'groupId': 'BG000'}, {'value': '76.4', 'spread': '8.55', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '21.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2006-10-18', 'resultsFirstSubmitDate': '2009-02-24', 'studyFirstSubmitQcDate': '2006-10-18', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-03-27', 'studyFirstPostDateStruct': {'date': '2006-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination', 'timeFrame': '0-3 days post-vaccination', 'description': 'Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)'}, {'measure': 'Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination', 'timeFrame': '21 days post-vaccination', 'description': 'GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Influenza Vaccine'], 'conditions': ['Influenza']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To submit remaining available sera to Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant aged 18 years or older on the day of inclusion.\n* Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.\n* Participant is in reasonably good health as assessed by the investigator.\n* Participant willing and able to meet protocol requirements.\n* Participant willing and able to give informed consent.\n* For a woman, inability to bear a child or negative serum/urine pregnancy test.\n\nExclusion Criteria:\n\n* Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.\n* An acute illness with or without fever (temperature ≥ 99.5 °F oral) in the 72 hours preceding enrollment in the trial.\n* Clinically significant findings in vital signs (including temperature ≥ 99.5 °F oral) on review of systems.\n* Self-reported history of severe adverse event to any influenza vaccine.\n* Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.\n* Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.\n* Vaccination planned in the 4 weeks following Fluzone® vaccination at Visit 1.\n* Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.\n* Immunocompromising or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.\n* Receipt of blood or blood products within the 3 months preceding enrollment in the study.\n* Diabetes mellitus requiring pharmacological control.\n* Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.\n* Person deprived of freedom by an administrative or court order (having legal or medical guardian).\n* For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial.\n* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.\n* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.\n* Prior personal history of Guillain-Barré syndrome."}, 'identificationModule': {'nctId': 'NCT00389532', 'briefTitle': 'Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)', 'orgStudyIdInfo': {'id': 'GRC35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'aged 19 to 59 years', 'interventionNames': ['Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'aged ≥ 60 years', 'interventionNames': ['Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)']}], 'interventions': [{'name': 'Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)', 'type': 'BIOLOGICAL', 'otherNames': ['2006-2007 Fluzone® vaccine'], 'description': 'Influenza vaccine', 'armGroupLabels': ['1']}, {'name': 'Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)', 'type': 'BIOLOGICAL', 'otherNames': ['2006-2007 Fluzone® vaccine'], 'description': 'Influenza vaccine', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}