Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-30 @ 8:32 AM
Study NCT ID:
NCT00313950
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2006-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008457', 'term': 'Measles'}, {'id': 'D009107', 'term': 'Mumps'}, {'id': 'D012409', 'term': 'Rubella'}, {'id': 'D006506', 'term': 'Hepatitis A'}], 'ancestors': [{'id': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D019351', 'term': 'Rubulavirus Infections'}, {'id': 'D010309', 'term': 'Parotitis'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018355', 'term': 'Rubivirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022542', 'term': 'Measles-Mumps-Rubella Vaccine'}], 'ancestors': [{'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D008458', 'term': 'Measles Vaccine'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D009108', 'term': 'Mumps Vaccine'}, {'id': 'D012411', 'term': 'Rubella Vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 470}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-17', 'studyFirstSubmitDate': '2006-04-11', 'studyFirstSubmitQcDate': '2006-04-11', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.', 'timeFrame': 'Day 7 - Day 196'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['measles', 'rubella', 'mumps', 'hepatitis A'], 'conditions': ['Measles', 'Mumps', 'Rubella', 'Hepatitis A']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 12-13 months on the day of inclusion\n* Born at full term of pregnancy (\\>37 weeks) with a birth weight ≥ 2.5 kg\n* Informed consent form signed by the parent(s) or other legal representative\n* Able to attend all scheduled visits and to comply with all trial procedures\n* Subjects having received only one or no injection of vaccine against Measles\n* Subjects anti-HAV seronegative according to the results obtained at the screening visit\\*\n\nExclusion Criteria:\n\n* Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination\n* Planned participation in another clinical trial during the present trial period\n* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy\n* Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances\n* Chronic illness at a stage that could interfere with trial conduct or completion\n* Blood or blood-derived products received in the past 3 months\n* Any vaccination in the 4 weeks preceding the first trial vaccination\n* Vaccination planned in the 4 weeks following any trial vaccination\n* History of hepatitis A, Mumps, Measles and/or Rubella infection (confirmed either clinically, serologically or microbiologically)\n* Previous vaccination against hepatitis A with the trial vaccine or another vaccine\n* Previous vaccination against Mumps, Measles and Rubella with a Mumps, Measles and Rubella trivalent combined vaccine\n* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination\n* History of seizures\n* Febrile illness (axillary temperature ≥37.4°C\\]) on the day of inclusion'}, 'identificationModule': {'nctId': 'NCT00313950', 'briefTitle': 'Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of AVAXIM™ 80U-Pediatric Administered Alone or Concomitantly With TRIMOVAX™ in 12-13 Months Old Healthy Hepatitis A Seronegative Turkish Children', 'orgStudyIdInfo': {'id': 'HAF65'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'interventionNames': ['Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'interventionNames': ['Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella']}], 'interventions': [{'name': 'Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella', 'type': 'BIOLOGICAL', 'otherNames': ['AVAXIM™', 'TRIMOVAX™'], 'description': '0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28)', 'armGroupLabels': ['Group 1']}, {'name': 'Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['TRIMOVAX™', 'AVAXIM™'], 'description': '0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)', 'armGroupLabels': ['Group 2']}, {'name': 'Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella', 'type': 'BIOLOGICAL', 'otherNames': ['AVAXIM™', 'TRIMOVAX™'], 'description': '0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}