Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:56 PM
Study NCT ID:
NCT01031303
Status:
COMPLETED
Last Update Posted:
2011-10-05
First Post:
2009-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-04', 'studyFirstSubmitDate': '2009-12-10', 'studyFirstSubmitQcDate': '2009-12-10', 'lastUpdatePostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination.', 'timeFrame': '30 days post-vaccination'}], 'secondaryOutcomes': [{'measure': 'To provide information concerning the safety after booster administration of TETRAXIM™.', 'timeFrame': '30 days post-vaccination and entire study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diphtheria', 'Tetanus', 'Pertussis', 'Poliomyelitis', 'PENTAXIM™', 'TETRAXIM™'], 'conditions': ['Diphtheria', 'Tetanus', 'Pertussis', 'Poliomyelitis']}, 'referencesModule': {'references': [{'pmid': '23077849', 'type': 'DERIVED', 'citation': 'Pancharoen C, Chotpitayasunondh T, Chuenkitmongkol S, Ortiz E. Long-term immunogenicity assessment of a DTaP-IPV//PRP-T vaccine given at 2, 4, 6 and 18-19 months of age, and immunogenicity and safety of a DTaP-IPV vaccine given as a booster dose at 4 to 6 years of age in Thai children. Southeast Asian J Trop Med Public Health. 2012 May;43(3):687-98.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and 6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi pasteur DTacP-IPV// PRP\\~T vaccine (PENTAXIM™) as a three-dose primary and booster vaccinations.\n\nPrimary Objective :\n\n* To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (Pertussis toxoid \\[PT\\], Filamentous Haemagglutinin \\[FHA\\]) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age.\n\nSecondary Objectives :\n\n* To describe the antibody persistence in terms of anti-pertussis antibody levels (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria, Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose (at Visit 1) in all subjects at 4-6 years of age.\n* To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age.\n* To describe the safety after the booster dose of the study vaccine.", 'detailedDescription': "All participants that previously completed the three-dose primary and the booster vaccinations in the study E2I34 (NCT 00255021) will be contacted to enroll in this study to receive sanofi pasteur's DTacP IPV combined vaccine (Tetraxim™) at 4 to 6 years of age.\n\nParticipants will receive the study vaccine \\[sanofi pasteur's DTacP-IPV vaccine (TETRAXIM™)\\] at 4 to 6 years of age (at visit 1)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Aged 4-6 years inclusive on the day of inclusion\n* Child having completed the three-dose vaccination and the booster vaccination with DTacP-IPV//PRP\\~T combined vaccine (PENTAXIM™) of the study E2I34\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\nExclusion Criteria :\n\n* Participation in another clinical trial in the 4 weeks preceding the trial inclusion\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 vaccine components or history of a life threatening reaction to the trial vaccine 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 or current or planned administration during the trial (including immunoglobulins)\n* Any vaccination in the 4 weeks preceding the trial vaccination\n* History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically)\n* Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human immunodeficiency virus (HIV) infection\n* Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study E2I34\n* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination\n* History of/current major neurological diseases or seizures\n* Febrile illness (temperature ≥ 38°C) or acute illness on the day of inclusion.\n* Serious or severe reaction after a previous dose of any vaccine containing pertussis antigen, such as\n* encephalopathy (with or without convulsions) in the 7days following previous administration of a pertussis containing vaccine,\n* temperature more than 39.5°C within 48 hours following vaccine injection, not due to another identifiable cause\n* inconsolable crying equal or more than 3 hours within 48 hours following vaccine injection,\n* hypotonic hyporesponsive episode within 48 hours following vaccine injection,\n* seizures with or without fever within 3 days following vaccine injection.'}, 'identificationModule': {'nctId': 'NCT01031303', 'briefTitle': 'Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': "Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given as a Booster Dose at 4 to 6 Years of Life in Children Previously Vaccinated With PENTAXIM™ in the Study E2I34", 'orgStudyIdInfo': {'id': 'E2I57'}, 'secondaryIdInfos': [{'id': 'UTN: U1111-1112-2680', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'interventionNames': ['Biological: DTacP-IPV combined vaccine (TETRAXIM™)']}], 'interventions': [{'name': 'DTacP-IPV combined vaccine (TETRAXIM™)', 'type': 'BIOLOGICAL', 'otherNames': ['TETRAXIM™'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'sanofi pasteur SA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}