Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-31 @ 11:55 PM
Study NCT ID:
NCT00569894
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2007-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post Marking Study to Evaluate the Safety of FluMist in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613429', 'term': 'FluMist'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-06', 'studyFirstSubmitDate': '2007-12-06', 'studyFirstSubmitQcDate': '2007-12-06', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess Medically Attended Events(MAEs)of anaphylaxis,urticaria, asthma,wheezing,pre-specified grouped diagnoses,and rare events related to wild-type influenza,MAEs-qualify as SAEs,in:emergency department,clinic,and hospital setting.', 'timeFrame': '1, 3, 21, or 42 days post dose; 6 months post dose; entire study period)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess the safety of FluMist vaccination', 'detailedDescription': '* To assess the safety of FluMist vaccination Rates of medically attended events in FluMist recipients, including serious adverse events (SAEs), anaphylaxis , urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza, will be compared to rates in multiple non-randomized control groups.\n* To assess the safety of annual FluMist re-vaccination \\[Rates of MAEs in the subset of children who receive FluMist in ≥2 consecutive years will be compared to rates in first-time vaccinees during the same season.\\]\n* To assess the safety of FluMist vaccination in children previously vaccinated with trivalent inactivated influenza vaccine (TIV) \\[Rates of MAEs in the subset of children who received one or more prior TIV vaccinations will be compared to rates in children who did not receive prior TIV.\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '24 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The populations to be assessed are FluMist recipients, TIV recipient controls, and unvaccinated controls.\n\nMembers of the Kaiser Permanente Health Care Plan may be included in this study as part of routine care at their participating health centers within the Kaiser Permanente health maintenance organization (HMO) of Northern California.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Age: born within the same calendar quarter as the reference FluMist vaccinee.\n\nExclusion Criteria:\n\n* Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group.'}, 'identificationModule': {'nctId': 'NCT00569894', 'briefTitle': 'A Post Marking Study to Evaluate the Safety of FluMist in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting', 'orgStudyIdInfo': {'id': 'MI-MA162'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2', 'description': 'TIV', 'interventionNames': ['Biological: TIV (Injection)']}, {'label': '1', 'description': 'FluMist', 'interventionNames': ['Biological: FLuMist']}, {'label': '3', 'description': 'Unvaccinated', 'interventionNames': ['Other: Unvaccinated Control']}], 'interventions': [{'name': 'FLuMist', 'type': 'BIOLOGICAL', 'description': 'One or two vaccinations with FluMist depending on prior vaccination status.', 'armGroupLabels': ['1']}, {'name': 'TIV (Injection)', 'type': 'BIOLOGICAL', 'description': 'One or two injections of TIV depending on previous status.', 'armGroupLabels': ['2']}, {'name': 'Unvaccinated Control', 'type': 'OTHER', 'description': 'no vaccine', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Seth Toback, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'MedImmune, LLC'}}}}