Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-28 @ 10:37 PM
Study NCT ID:
NCT00619502
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D006509', 'term': 'Hepatitis B'}], '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': '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'}, {'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': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625558', 'term': 'DTaP-IPV-HB-PRP-T vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'DTaP-IPV-HepB-PRP~T', 'description': 'All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\\~T at 15 to 18 months of age in the present study.', 'otherNumAtRisk': 130, 'otherNumAffected': 56, 'seriousNumAtRisk': 130, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Pentaxim™ + Engerix B™', 'description': 'All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\\~T at 15 to 18 months of age in the present study.', 'otherNumAtRisk': 124, 'otherNumAffected': 67, 'seriousNumAtRisk': 124, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 50, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 56, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 67, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 51, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 61, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 43, 'numAffected': 43}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV-HepB-PRP~T', 'description': 'All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\\~T at 15 to 18 months of age in the present study.'}, {'id': 'OG001', 'title': 'Pentaxim™ + Engerix B™', 'description': 'All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\\~T at 15 to 18 months of age in the present study.'}], 'classes': [{'title': 'Anti-Hep B Pre-booster (N = 109, 103)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Hep B Post-booster (N = 111, 103)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRP Pre-booster (N = 113,102)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRP Post-booster (N = 114, 103)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria Pre-booster (N = 104, 94)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria Post-booster (N = 112, 98)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus Pre-booster (N = 97, 90)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus Post-booster (N = 109, 96)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 1 Pre-booster (N = 88, 86)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 1 Post-booster (N = 105, 87)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2 Pre-booster (N = 84, 87)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2 Post-booster (N = 101, 83)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3 Pre-booster (N = 88,86)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3 Post-booster (N = 102, 84)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PT Post-booster (N = 86, 79)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA Post-booster (N = 73,77)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 before and Day 30 Post-booster vaccination', 'description': 'Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV-HepB-PRP~T', 'description': 'All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\\~T at 15 to 18 months of age in the present study.'}, {'id': 'OG001', 'title': 'Pentaxim™ + Engerix B™', 'description': 'All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\\~T at 15 to 18 months of age in the present study.'}], 'classes': [{'title': 'Anti-Hep B Pre-booster (N = 109, 103)', 'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000', 'lowerLimit': '32.3', 'upperLimit': '60.7'}, {'value': '223', 'groupId': 'OG001', 'lowerLimit': '176', 'upperLimit': '282'}]}]}, {'title': 'Anti-Hep B Post-booster (N = 111, 103)', 'categories': [{'measurements': [{'value': '1379', 'groupId': 'OG000', 'lowerLimit': '916', 'upperLimit': '2078'}, {'value': '26189', 'groupId': 'OG001', 'lowerLimit': '19133', 'upperLimit': '35846'}]}]}, {'title': 'Anti-PRP Pre-booster (N = 113, 102)', 'categories': [{'measurements': [{'value': '0.724', 'groupId': 'OG000', 'lowerLimit': '0.541', 'upperLimit': '0.968'}, {'value': '0.612', 'groupId': 'OG001', 'lowerLimit': '0.443', 'upperLimit': '0.844'}]}]}, {'title': 'Anti-PRP Post-booster (N = 114, 103)', 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000', 'lowerLimit': '55.8', 'upperLimit': '94.3'}, {'value': '86.9', 'groupId': 'OG001', 'lowerLimit': '69.8', 'upperLimit': '108'}]}]}, {'title': 'Anti-Diphtheria Pre-booster (N = 104, 94)', 'categories': [{'measurements': [{'value': '0.028', 'groupId': 'OG000', 'lowerLimit': '0.022', 'upperLimit': '0.035'}, {'value': '0.032', 'groupId': 'OG001', 'lowerLimit': '0.024', 'upperLimit': '0.041'}]}]}, {'title': 'Anti-Diphtheria Post-booster (N = 112, 98)', 'categories': [{'measurements': [{'value': '5.09', 'groupId': 'OG000', 'lowerLimit': '3.89', 'upperLimit': '6.66'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '7.59', 'upperLimit': '13.8'}]}]}, {'title': 'Anti-Tetanus Pre-booster (N = 97, 90)', 'categories': [{'measurements': [{'value': '0.244', 'groupId': 'OG000', 'lowerLimit': '0.204', 'upperLimit': '0.292'}, {'value': '0.194', 'groupId': 'OG001', 'lowerLimit': '0.158', 'upperLimit': '0.238'}]}]}, {'title': 'Anti-Tetanus Post-booster (N = 109, 96)', 'categories': [{'measurements': [{'value': '8.98', 'groupId': 'OG000', 'lowerLimit': '7.52', 'upperLimit': '10.7'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '15.8'}]}]}, {'title': 'Anti-Polio 1 Pre-booster (N= 88, 86)', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000', 'lowerLimit': '81.6', 'upperLimit': '148'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '82.4', 'upperLimit': '157'}]}]}, {'title': 'Anti-Polio 1 Post-booster (N = 105, 87)', 'categories': [{'measurements': [{'value': '5477', 'groupId': 'OG000', 'lowerLimit': '4401', 'upperLimit': '6814'}, {'value': '9050', 'groupId': 'OG001', 'lowerLimit': '7134', 'upperLimit': '11480'}]}]}, {'title': 'Anti-Polio 2 Pre-booster (N = 84, 87)', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000', 'lowerLimit': '84.9', 'upperLimit': '153'}, {'value': '131', 'groupId': 'OG001', 'lowerLimit': '95.3', 'upperLimit': '179'}]}]}, {'title': 'Anti-Polio 2 Post-booster (N = 101, 83)', 'categories': [{'measurements': [{'value': '6099', 'groupId': 'OG000', 'lowerLimit': '4916', 'upperLimit': '7566'}, {'value': '9170', 'groupId': 'OG001', 'lowerLimit': '7170', 'upperLimit': '11727'}]}]}, {'title': 'Anti-Polio 3 Pre-booster (N = 88, 86)', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000', 'lowerLimit': '33.1', 'upperLimit': '67.1'}, {'value': '101', 'groupId': 'OG001', 'lowerLimit': '73.0', 'upperLimit': '141'}]}]}, {'title': 'Anti-Polio 3 Post-booster (N = 102, 84)', 'categories': [{'measurements': [{'value': '5542', 'groupId': 'OG000', 'lowerLimit': '4156', 'upperLimit': '7392'}, {'value': '10152', 'groupId': 'OG001', 'lowerLimit': '7806', 'upperLimit': '13205'}]}]}, {'title': 'Anti-PT Pre-booster (N = 86, 87)', 'categories': [{'measurements': [{'value': '6.08', 'groupId': 'OG000', 'lowerLimit': '4.74', 'upperLimit': '7.79'}, {'value': '7.49', 'groupId': 'OG001', 'lowerLimit': '5.97', 'upperLimit': '9.41'}]}]}, {'title': 'Anti-PT Post-booster (N = 113, 95)', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000', 'lowerLimit': '137', 'upperLimit': '187'}, {'value': '237', 'groupId': 'OG001', 'lowerLimit': '202', 'upperLimit': '278'}]}]}, {'title': 'Anti-FHA Pre-booster (N = 74, 81)', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '9.59', 'upperLimit': '16.4'}, {'value': '8.18', 'groupId': 'OG001', 'lowerLimit': '6.49', 'upperLimit': '10.3'}]}]}, {'title': 'Anti-FHA Post-booster (N = 111, 97)', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000', 'lowerLimit': '194', 'upperLimit': '254'}, {'value': '234', 'groupId': 'OG001', 'lowerLimit': '201', 'upperLimit': '272'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 before and Day 30 post-booster vaccination', 'description': 'Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'GMTs were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per Protocol Population).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV-HepB-PRP-T', 'description': 'All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.'}, {'id': 'OG001', 'title': 'Pentaxim™ + Engerix B™', 'description': 'All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Erythema', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Extensive Swelling of Vaccinated Limb', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pyrexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Vomiting', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Crying', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Crying', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Somnolence', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Anorexia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 7 post-booster vaccination', 'description': 'Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.\n\nGrade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying \\> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited reactions were assessed in all participants who received a booster dose of DTaP-IPV-Hep B-PRP\\~T according to the primary series received (Safety Analysis Population).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DTaP-IPV-HepB-PRP~T', 'description': 'All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\\~T at 15 to 18 months of age in the present study.'}, {'id': 'FG001', 'title': 'Pentaxim™ + Engerix B™', 'description': 'All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\\~T at 15 to 18 months of age in the present study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 14 December 2007 to 07 January 2008 at 1 clinical center in Turkey.', 'preAssignmentDetails': 'A total of 254 participants who met all inclusion, but no exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DTaP-IPV-HepB-PRP~T', 'description': 'All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\\~T at 15 to 18 months of age in the present study.'}, {'id': 'BG001', 'title': 'Pentaxim™ + Engerix B™', 'description': 'All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\\~T at 15 to 18 months of age in the present study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '0.198', 'groupId': 'BG000'}, {'value': '17.6', 'spread': '0.279', 'groupId': 'BG001'}, {'value': '17.6', 'spread': '0.241', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-08', 'studyFirstSubmitDate': '2008-02-11', 'resultsFirstSubmitDate': '2014-02-22', 'studyFirstSubmitQcDate': '2008-02-11', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-22', 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™', 'timeFrame': 'Day 0 before and Day 30 Post-booster vaccination', 'description': 'Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.'}, {'measure': 'Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T', 'timeFrame': 'Day 0 before and Day 30 post-booster vaccination', 'description': 'Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).'}, {'measure': 'Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T', 'timeFrame': 'Day 0 up to Day 7 post-booster vaccination', 'description': 'Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.\n\nGrade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying \\> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis B', 'Polio', 'Diphtheria', 'Pertussis', 'H.influenzae type b'], 'conditions': ['Diphtheria', 'Polio', 'Pertussis', 'Hepatitis B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a follow-up of Study A3L10 (NCT00315055)\n\nImmunogenicity\n\n* To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP\\~T or PENTAXIM™ and ENGERIX B®.\n* To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP\\~T.\n\nSafety\n\n\\- To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP\\~T.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '15 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP\\~T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4 months of age.\n* Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive).\n* Informed Consent Form signed by the parent(s) or other legal representative(s) and an institution official other than an Investigator.\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 booster 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 corticosteroid therapy.\n* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to 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 last 3 months.\n* Any vaccination in the 4 weeks preceding the booster vaccination.\n* Any vaccination planned until second Visit.\n* History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).\n* Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s).\n* Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.\n* Any vaccine-related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10 (NCT00315055).\n* Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion.\n* Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; temperature \\> 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for \\> 3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.'}, 'identificationModule': {'nctId': 'NCT00619502', 'briefTitle': 'Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety Study of a Booster Dose of DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series at 2, 3 and 4 Months of Age in Healthy Turkish Infants', 'orgStudyIdInfo': {'id': 'A3L22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DTaP-IPV-Hep B-PRP~T Vaccine Group', 'description': 'Participants received a primary series of 3 vaccinations with DTaP-IPV-Hep B-PRP\\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-HepB-PRP\\~T at 15 to 18 months of age in the present study', 'interventionNames': ['Biological: DTaP-IPV-HB-PRP~T vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentaxim™ + Engerix B™ Vaccines Group', 'description': 'Participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-Hep B-PRP\\~T at 15 to 18 months of age in the present study.', 'interventionNames': ['Biological: DTaP-IPV-HB-PRP~T vaccine']}], 'interventions': [{'name': 'DTaP-IPV-HB-PRP~T vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, intramuscular (IM)', 'armGroupLabels': ['DTaP-IPV-Hep B-PRP~T Vaccine Group', 'Pentaxim™ + Engerix B™ Vaccines Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}