Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-24 @ 10:30 PM
Study NCT ID:
NCT00534833
Status:
COMPLETED
Last Update Posted:
2013-11-21
First Post:
2007-09-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}], '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': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C122182', 'term': 'diphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccine'}, {'id': 'D011055', 'term': 'Poliovirus Vaccine, Oral'}], 'ancestors': [{'id': 'D023321', 'term': 'Poliovirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, '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 event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: DTaP-Hep B-PRP~T + OPV', 'description': 'Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.', 'otherNumAtRisk': 182, 'otherNumAffected': 101, 'seriousNumAtRisk': 182, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Group 2: Tritanrix-Hep B/ Hib™ + OPV', 'description': 'Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.', 'otherNumAtRisk': 180, 'otherNumAffected': 142, 'seriousNumAtRisk': 180, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 124}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site erythemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 90}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 39}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 41}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 42}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 71}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Typhoid fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Urinary tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: DTaP-Hep B-PRP~T + OPV', 'description': 'Participants received a booster dose of the DTaP-Hep B-PRP\\~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP\\~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203.'}, {'id': 'OG001', 'title': 'Group 2: Tritanrix-Hep B/ Hib™ + OPV', 'description': 'Participants received a booster dose of the DTaP-Hep B-PRP\\~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203'}], 'classes': [{'title': 'Anti-Hep B, Pre-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Hep B, Post-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRP, Pre-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRP, Post-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria, Pre-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria, Post-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus, Pre-booster (N = 98, 97)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus, Post-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Pertussis, 4-Fold Increase (N = 96, 92)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Pertussis, Booster response (N = 96, 92)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, 4-Fold Increase (N = 94, 93)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, Booster response (N = 94, 93)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 Days post-vaccination', 'description': 'Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria.\n\nBooster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: DTaP-Hep B-PRP~T + OPV', 'description': 'Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.'}, {'id': 'OG001', 'title': 'Group 2: Tritanrix-Hep B/ Hib™ + OPV', 'description': 'Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.'}], 'classes': [{'title': 'Anti-Hepatitis B Pre-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '6.75', 'groupId': 'OG000', 'lowerLimit': '5.17', 'upperLimit': '8.81'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '24.0'}]}]}, {'title': 'Anti-Hepatitis B Post-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '188'}, {'value': '1352', 'groupId': 'OG001', 'lowerLimit': '883', 'upperLimit': '2071'}]}]}, {'title': 'Anti-PRP Pre-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '0.908', 'groupId': 'OG000', 'lowerLimit': '0.631', 'upperLimit': '1.31'}, {'value': '3.76', 'groupId': 'OG001', 'lowerLimit': '2.76', 'upperLimit': '5.13'}]}]}, {'title': 'Anti-PRP Post-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000', 'lowerLimit': '47.1', 'upperLimit': '88.2'}, {'value': '103', 'groupId': 'OG001', 'lowerLimit': '82.8', 'upperLimit': '129'}]}]}, {'title': 'Anti-Diphtheria Pre-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '0.016', 'groupId': 'OG000', 'lowerLimit': '0.012', 'upperLimit': '0.021'}, {'value': '0.013', 'groupId': 'OG001', 'lowerLimit': '0.010', 'upperLimit': '0.018'}]}]}, {'title': 'Anti-Diphtheria Post-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '2.81', 'groupId': 'OG000', 'lowerLimit': '2.01', 'upperLimit': '3.92'}, {'value': '1.15', 'groupId': 'OG001', 'lowerLimit': '0.779', 'upperLimit': '1.70'}]}]}, {'title': 'Anti-Tetanus Pre-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '0.382', 'groupId': 'OG000', 'lowerLimit': '0.320', 'upperLimit': '0.455'}, {'value': '0.500', 'groupId': 'OG001', 'lowerLimit': '0.429', 'upperLimit': '0.584'}]}]}, {'title': 'Anti-Tetanus Post-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '18.9'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '16.4'}]}]}, {'title': 'Anti-Pertussis Pre-booster (N = 96, 92)', 'categories': [{'measurements': [{'value': '9.11', 'groupId': 'OG000', 'lowerLimit': '7.77', 'upperLimit': '10.7'}, {'value': '6.94', 'groupId': 'OG001', 'lowerLimit': '5.20', 'upperLimit': '9.25'}]}]}, {'title': 'Anti-Pertussis Post-booster (N = 98, 98)', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000', 'lowerLimit': '174', 'upperLimit': '228'}, {'value': '105', 'groupId': 'OG001', 'lowerLimit': '76.9', 'upperLimit': '144'}]}]}, {'title': 'Anti-FHA Pre-booster (N = 95, 93)', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '18.2'}, {'value': '2.10', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '2.51'}]}]}, {'title': 'Anti-FHA Post-booster (N = 97, 98)', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000', 'lowerLimit': '206', 'upperLimit': '263'}, {'value': '117', 'groupId': 'OG001', 'lowerLimit': '101', 'upperLimit': '135'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: DTaP-Hep B-PRP~T + OPV', 'description': 'Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.'}, {'id': 'OG001', 'title': 'Group 2: Tritanrix-Hep B/ Hib™ + OPV', 'description': 'Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.'}], 'classes': [{'title': 'Injection site Pain', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Injection site Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Injection site Erythema', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Injection site Erythema', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Injection site Swelling', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Injection site Swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Extensive swelling of vaccinated limb', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Pyrexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Crying', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Crying post-vaccination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence post-vaccination', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Somnolence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Anorexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 7 post-vaccination', 'description': 'Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.\n\nGrade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for \\>3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety was assessed on the safety analysis (intent-to-treat) population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: DTaP-Hep B-PRP~T + OPV', 'description': 'Participants received a booster dose of DTaP-Hep B-PRP\\~T concomitantly with OPV at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP\\~T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.'}, {'id': 'FG001', 'title': 'Group 2: Tritanrix-Hep B/ Hib™ + OPV', 'description': 'Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with OPV at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were randomized and enrolled from 21 September 2007 to 03 December 2007 in 2 clinical centers in the Philippines.', 'preAssignmentDetails': 'A total of 362 participants who met the inclusion but not the exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: DTaP-Hep B-PRP~T + OPV', 'description': 'Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.'}, {'id': 'BG001', 'title': 'Group 2: Tritanrix-Hep B/ Hib™ + OPV', 'description': 'Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '362', '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': '15.9', 'spread': '0.946', 'groupId': 'BG000'}, {'value': '15.9', 'spread': '0.942', 'groupId': 'BG001'}, {'value': '15.9', 'spread': '0.945', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Philippines', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '362', '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': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2007-09-24', 'resultsFirstSubmitDate': '2013-09-19', 'studyFirstSubmitQcDate': '2007-09-24', 'lastUpdatePostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-19', 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV', 'timeFrame': '28 Days post-vaccination', 'description': 'Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria.\n\nBooster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio.'}, {'measure': 'Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV', 'timeFrame': 'Day 0 up to Day 7 post-vaccination', 'description': 'Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.\n\nGrade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for \\>3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diphtheria', 'Tetanus', 'Pertussis', 'Hepatitis B Hansenula (HB)', 'Haemophilus influenzae type b'], 'conditions': ['Diphtheria', 'Tetanus', 'Pertussis', 'Hepatitis B', 'Haemophilus Influenzae Type b']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The present trial is a follow-up of AL203 study (NCT00343889).\n\nPrimary Objectives:\n\nTo describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP\\~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine \\[OPV\\]).\n\nSecondary Objective:\n\nTo describe the safety profile of a booster dose of DTaP-HB-PRP\\~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.', 'detailedDescription': 'Study participants will receive a booster vaccination of DTaP-HB-PRP\\~T or Tritanrix-HepB/Hib™ either concomitantly with Oral Polio Vaccine (OPV) following the completion of a three dose primary series with DTaP-Hep B-PRP-T combined vaccine or Tritanrix HepB/Hib™, both given concomitantly with OPV. Participants will receive a booster dose of the vaccine they had received in the primary series, and a concomitant dose of OPV Study AL203 (NCT00343889).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '15 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive)\n* Participated in the AL203 study and completed the three-dose primary series with either DTaP-HB-PRP\\~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age\n* Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)\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 vaccination\n* Planned participation in another clinical trial during the present trial period\n* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months\n* Known 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 trial vaccination\n* Vaccination planned in the 4 weeks following the trial vaccination\n* Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion\n* History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)\n* Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, or poliovirus 3 types antigen since the end of the primary series\n* Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination\n* Serious adverse event related to any vaccination in the AL203 study.'}, 'identificationModule': {'nctId': 'NCT00534833', 'briefTitle': 'Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine or Tritanrix HepB/Hib™ at 15 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants', 'orgStudyIdInfo': {'id': 'AL205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'DTaP-Hep B-PRP-T + OPV vaccine group', 'interventionNames': ['Biological: DTaP-HB-PRP~T vaccine', 'Biological: Oral Polio Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Tritanrix-HepB/Hib™ + OPV vaccine group', 'interventionNames': ['Biological: Tritanrix-HepB/Hib™', 'Biological: Oral Polio Vaccine']}], 'interventions': [{'name': 'DTaP-HB-PRP~T vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Group 1']}, {'name': 'Tritanrix-HepB/Hib™', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Group 2']}, {'name': 'Oral Polio Vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Oral', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manila', 'country': 'Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Quezon City', 'country': 'Philippines', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}