Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 7:38 PM
Study NCT ID:
NCT00950456
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2009-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2009-07-30', 'studyFirstSubmitQcDate': '2009-07-30', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Influenza', 'Pandemic Influenza']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The enrollment of subjects in this study will follow national vaccination policy decisions in the UK.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:\n\n* They will be administered CELVAPAN (= Baxter´s H1N1 pandemic influenza vaccine)\n* They are 2 months of age or older at the time of first vaccine administration\n* Their medical history is available\n* The investigator believes they will comply with the foreseen vaccination schedule and will reliably observe signs or symptoms of adverse events during the observational period\n* They and/or their parent(s)/legal guardian(s) provide written informed consent, and assent where appropriate, prior to study entry according to national law\n\nExclusion Criteria:\n\nMale and female subjects will be excluded from participation in this study if:\n\n* They have already been administered another H1N1 pandemic vaccine\n* They have any contraindication to vaccination (as per the Summary of Product Characteristics and/or relevant national immunization guidelines)'}, 'identificationModule': {'nctId': 'NCT00950456', 'briefTitle': 'Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alachua Government Services, Inc.'}, 'officialTitle': 'A Prospective Non-Interventional Observational Study to Assess the Safety of Two Vaccinations of a Vero Cell-Derived, Whole Virus H1N1 Pandemic Influenza Vaccine in Subjects Exposed to the Vaccine Through Policies by Governments or Health Authorities', 'orgStudyIdInfo': {'id': '820901'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'H1N1 Pandemic Influenza Vaccine', 'description': 'Subjects will be enrolled and vaccinated according to national policy and standard practice.', 'interventionNames': ['Biological: H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)']}], 'interventions': [{'name': 'H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)', 'type': 'BIOLOGICAL', 'otherNames': ['CELVAPAN'], 'description': 'It is anticipated that subjects will receive two intramuscular injections approximately 3 weeks apart. The vaccine will be provided in two doses, one for adults, the other for children.', 'armGroupLabels': ['H1N1 Pandemic Influenza Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700', 'city': 'Bludenz', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 47.15476, 'lon': 9.82255}}, {'zip': '6166', 'city': 'Fulpmes', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 47.15202, 'lon': 11.34922}}, {'zip': '6060', 'city': 'Hall in Tirol', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 47.28333, 'lon': 11.51667}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Practice for Travel Medicine', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '9020', 'city': 'Klagenfurt', 'country': 'Austria', 'facility': 'City Council (Magistrat) Klagenfurt (Health & Food Department)', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': '6330', 'city': 'Kufstein', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 47.58333, 'lon': 12.16667}}, {'zip': '5571', 'city': 'Mariapfarr', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 47.15, 'lon': 13.75}}, {'zip': '6173', 'city': 'Oberperfuss', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 47.24451, 'lon': 11.24755}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '6410', 'city': 'Telfs', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 47.30707, 'lon': 11.06817}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department of Specific Prophylaxis and Tropical Medicine', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1100', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Hanusch Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1100', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Wiener Gebietskrankenkasse (Health insurance center Vienna)', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '8570', 'city': 'Voitsberg', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 47.04445, 'lon': 15.15313}}, {'zip': '4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'General Practice', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}], 'overallOfficials': [{'name': 'Baxter BioScience Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baxter Healthcare Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alachua Government Services, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'David Perry, MD; Sponsor´s signatory', 'oldOrganization': 'Baxter Innovations GmbH'}}}}