Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-01 @ 3:32 PM
Study NCT ID:
NCT00408395
Status:
COMPLETED
Last Update Posted:
2016-12-01
First Post:
2006-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children
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'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2006-12-05', 'studyFirstSubmitQcDate': '2006-12-05', 'lastUpdatePostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the immunogenicity of the 2 vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by the hemagglutination inhibition (HI) test'}], 'secondaryOutcomes': [{'measure': 'To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test'}, {'measure': 'To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart'}]}, 'conditionsModule': {'keywords': ['influenza', 'children', 'vaccine', 'influenza disease'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '19561422', 'type': 'RESULT', 'citation': "Vesikari T, Pellegrini M, Karvonen A, Groth N, Borkowski A, O'Hagan DT, Podda A. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J. 2009 Jul;28(7):563-71. doi: 10.1097/INF.0b013e31819d6394."}]}, 'descriptionModule': {'briefSummary': 'This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.', 'detailedDescription': 'A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine versus Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine in Healthy Children'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 months to \\< 36 months of age\n\nExclusion Criteria:\n\n* Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)\n* Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, or surgery planned during the study period.\n* Known or suspected impairment/alteration of immune function\n* History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function'}, 'identificationModule': {'nctId': 'NCT00408395', 'briefTitle': 'Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a Commercially Available Influenza Vaccine Versus Two 0.25 mL Intramuscular Doses of a Commercially Available Influenza Vaccine in Healthy Children', 'orgStudyIdInfo': {'id': 'V70P2'}, 'secondaryIdInfos': [{'id': '2006-003181-34'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Trivalent Seasonal Influenza Vaccine', 'interventionNames': ['Biological: Influenza vaccine']}, {'type': 'EXPERIMENTAL', 'label': '2: Adjuvanted Trivalent Seasonal Influenza Vaccine', 'interventionNames': ['Biological: Influenza vaccine']}], 'interventions': [{'name': 'Influenza vaccine', 'type': 'BIOLOGICAL', 'description': 'Seasonal Influenza Vaccine', 'armGroupLabels': ['1: Trivalent Seasonal Influenza Vaccine', '2: Adjuvanted Trivalent Seasonal Influenza Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Tampere', 'country': 'Finland', 'facility': 'University of Tampere Medical School', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Novartis Vaccines (formerly Chiron Vaccines)', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}