Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT00254969
Status:
COMPLETED
Last Update Posted:
2012-04-17
First Post:
2005-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Pentaxim in South African Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}, {'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': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001885', 'term': 'Bordetella 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'C426945', 'term': 'Pentavac'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-16', 'studyFirstSubmitDate': '2005-11-15', 'studyFirstSubmitQcDate': '2005-11-15', 'lastUpdatePostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine.', 'timeFrame': '1 month post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diphteria', 'tetanus', 'haemophilus influenzae type b', 'poliomyelitis', 'pertussis'], 'conditions': ['Diphtheria', 'Tetanus', 'Haemophilus Infections', 'Pertussis', 'Poliomyelitis']}, 'referencesModule': {'references': [{'pmid': '22273029', 'type': 'DERIVED', 'citation': 'Madhi SA, Cutland C, Jones S, Groome M, Ortiz E. One-year post-primary antibody persistence and booster immune response to a DTaP-IPV//PRP~T vaccine (Pentaxim) given at 18 - 19 months of age in South African children primed at 6, 10 and 14 weeks of age with the same vaccine. S Afr Med J. 2011 Nov 28;101(12):879-83.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The present clinical study will assess the immunogenicity and reactogenicity of Aventis Pasteur's DTacP-IPV// PRP\\~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '24 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\< 24 hours on the day of inclusion\n\nExclusion Criteria:\n\n* At visit 01 (screening)\n* Illness at a stage that could interfere with trial conduct or completion.\n* Any vaccination preceding the trial participation (except Bacille Calmette-Guerin \\[BCG\\])\n* Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).\n* Planned participation in another clinical trial during the present trial period\n* Blood or blood-derived products received since birth.\n* Mother known as seropositive to HIV or hepatitis B.\n* Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination\n* History of/current seizures at visit 02 (first study vaccination)\n* Participation in another clinical trial preceding the first trial vaccination\n* Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid 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* Any vaccination preceding the first trial vaccination (except BCG)\n* History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).\n* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.\n* Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination'}, 'identificationModule': {'nctId': 'NCT00254969', 'briefTitle': 'Immunogenicity and Safety of Pentaxim in South African Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'orgStudyIdInfo': {'id': 'E2I43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib']}], 'interventions': [{'name': 'Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib', 'type': 'BIOLOGICAL', 'otherNames': ['PENTAXIM™'], 'description': '0.5 mL, Im', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Soweto', 'country': 'South Africa', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}