Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00404651
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2006-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
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': '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': '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': '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': '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': 'C000625558', 'term': 'DTaP-IPV-HB-PRP-T vaccine'}, {'id': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B 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 the first vaccination for up to 10 months (Day 300) post-vaccination.', 'description': 'Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.', 'eventGroups': [{'id': 'EG000', 'title': 'DTaP-IPV-HB-PRP~T Batch 1', 'description': 'Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\\~T), with one dose each at 2, 4, and 6 months of age.', 'otherNumAtRisk': 337, 'otherNumAffected': 220, 'seriousNumAtRisk': 337, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'DTaP-IPV-HB-PRP~T Batch 2', 'description': 'Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.', 'otherNumAtRisk': 345, 'otherNumAffected': 237, 'seriousNumAtRisk': 345, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'DTaP-IPV-HB-PRP~T Batch 3', 'description': 'Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.', 'otherNumAtRisk': 340, 'otherNumAffected': 225, 'seriousNumAtRisk': 340, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Infanrix Hexa™', 'description': 'Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.', 'otherNumAtRisk': 167, 'otherNumAffected': 95, 'seriousNumAtRisk': 167, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 68, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 63, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 329, 'numEvents': 56, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 220, 'numAffected': 220}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 237, 'numAffected': 237}, {'groupId': 'EG002', 'numAtRisk': 329, 'numEvents': 225, 'numAffected': 225}, {'groupId': 'EG003', 'numAtRisk': 155, 'numEvents': 95, 'numAffected': 95}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numEvents': 95, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 319, 'numEvents': 101, 'numAffected': 101}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 101, 'numAffected': 101}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 43, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 74, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 86, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 329, 'numEvents': 80, 'numAffected': 80}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 188, 'numAffected': 188}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 198, 'numAffected': 198}, {'groupId': 'EG002', 'numAtRisk': 329, 'numEvents': 193, 'numAffected': 193}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 83, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 75, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 317, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 315, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 62, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 75, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 329, 'numEvents': 70, 'numAffected': 70}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 93, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 110, 'numAffected': 110}, {'groupId': 'EG002', 'numAtRisk': 329, 'numEvents': 102, 'numAffected': 102}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 45, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 160, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 156, 'numAffected': 156}, {'groupId': 'EG002', 'numAtRisk': 329, 'numEvents': 148, 'numAffected': 148}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 62, 'numAffected': 62}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Heart Disease Congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Multiple Fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Food Intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Febrile Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Infantile Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Partial Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 340, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV-HB-PRP~T Batch 1', 'description': 'Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'DTaP-IPV-HB-PRP~T Batch 2', 'description': 'Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG002', 'title': 'DTaP-IPV-HB-PRP~T Batch 3', 'description': 'Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG003', 'title': 'Infanrix Hexa™', 'description': 'Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Anti-Hep B (N = 230, 234, 236, 119)', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '221', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '119', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Anti-PRP (N = 231, 236, 228, 119)', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '226', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '118', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Anti-Diphtheria (N = 231, 236, 228, 119)', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '222', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '118', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Anti-Tetanus (N = 231, 236, 227, 119)', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '227', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '119', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 150 (one month post-dose 3)', 'description': 'Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint.'}, {'type': 'PRIMARY', 'title': 'Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV-HB-PRP~T Batch 1', 'description': 'Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'DTaP-IPV-HB-PRP~T Batch 2', 'description': 'Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG002', 'title': 'DTaP-IPV-HB-PRP~T Batch 3', 'description': 'Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG003', 'title': 'Infanrix Hexa™', 'description': 'Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Anti-Pertussis (N= 228, 234, 223, 118)', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '218', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '113', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Anti-FHA (N= 227, 233, 221, 115)', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '216', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '111', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 150 (one month post-dose 3)', 'description': 'Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).'}, {'type': 'PRIMARY', 'title': 'Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV-HB-PRP~T Batch 1', 'description': 'Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'DTaP-IPV-HB-PRP~T Batch 2', 'description': 'Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG002', 'title': 'DTaP-IPV-HB-PRP~T Batch 3', 'description': 'Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG003', 'title': 'Infanrix Hexa™', 'description': 'Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Anti-Polio 1 (N = 231, 236, 225, 119)', 'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '225', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '119', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Anti-Polio 2 (N = 230, 236, 226, 118)', 'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '226', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '118', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Anti-Polio 3 (N = 230, 236, 226, 119)', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '226', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '117', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 150 (one month post-dose 3)', 'description': 'Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV-HB-PRP~T Batch 1', 'description': 'Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'DTaP-IPV-HB-PRP~T Batch 2', 'description': 'Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG002', 'title': 'DTaP-IPV-HB-PRP~T Batch 3', 'description': 'Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG003', 'title': 'Infanrix Hexa™', 'description': 'Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Anti-Hep B (N = 230, 234, 226, 119)', 'categories': [{'measurements': [{'value': '935', 'groupId': 'OG000', 'lowerLimit': '755', 'upperLimit': '1158'}, {'value': '1566', 'groupId': 'OG001', 'lowerLimit': '1288', 'upperLimit': '1905'}, {'value': '1009', 'groupId': 'OG002', 'lowerLimit': '814', 'upperLimit': '1252'}, {'value': '1576', 'groupId': 'OG003', 'lowerLimit': '1283', 'upperLimit': '1934'}]}]}, {'title': 'Anti-PRP (N = 231, 236, 228, 119)', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '9.77', 'upperLimit': '14.5'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '16.0'}, {'value': '11.5', 'groupId': 'OG002', 'lowerLimit': '9.26', 'upperLimit': '14.3'}, {'value': '6.68', 'groupId': 'OG003', 'lowerLimit': '5.10', 'upperLimit': '8.74'}]}]}, {'title': 'Anti-Diphtheria (N = 231, 236, 228, 119)', 'categories': [{'measurements': [{'value': '0.176', 'groupId': 'OG000', 'lowerLimit': '0.143', 'upperLimit': '0.217'}, {'value': '0.246', 'groupId': 'OG001', 'lowerLimit': '0.194', 'upperLimit': '0.311'}, {'value': '0.173', 'groupId': 'OG002', 'lowerLimit': '0.139', 'upperLimit': '0.214'}, {'value': '0.173', 'groupId': 'OG003', 'lowerLimit': '0.132', 'upperLimit': '0.226'}]}]}, {'title': 'Anti-Tetanus (N = 231, 236, 227, 119)', 'categories': [{'measurements': [{'value': '1.90', 'groupId': 'OG000', 'lowerLimit': '1.67', 'upperLimit': '2.15'}, {'value': '1.86', 'groupId': 'OG001', 'lowerLimit': '1.64', 'upperLimit': '2.10'}, {'value': '1.77', 'groupId': 'OG002', 'lowerLimit': '1.57', 'upperLimit': '2.01'}, {'value': '2.20', 'groupId': 'OG003', 'lowerLimit': '1.93', 'upperLimit': '2.52'}]}]}, {'title': 'Anti-Polio 1 (N = 231, 236, 225, 119)', 'categories': [{'measurements': [{'value': '860', 'groupId': 'OG000', 'lowerLimit': '725', 'upperLimit': '1021'}, {'value': '945', 'groupId': 'OG001', 'lowerLimit': '809', 'upperLimit': '1102'}, {'value': '843', 'groupId': 'OG002', 'lowerLimit': '712', 'upperLimit': '999'}, {'value': '1370', 'groupId': 'OG003', 'lowerLimit': '1082', 'upperLimit': '1736'}]}]}, {'title': 'Anti-Polio 2 (N = 230, 236, 226, 118)', 'categories': [{'measurements': [{'value': '1689', 'groupId': 'OG000', 'lowerLimit': '1429', 'upperLimit': '1996'}, {'value': '1665', 'groupId': 'OG001', 'lowerLimit': '1416', 'upperLimit': '1957'}, {'value': '1612', 'groupId': 'OG002', 'lowerLimit': '1374', 'upperLimit': '1892'}, {'value': '2337', 'groupId': 'OG003', 'lowerLimit': '1878', 'upperLimit': '2909'}]}]}, {'title': 'Anti-Polio 3 (N = 230, 235, 226, 117)', 'categories': [{'measurements': [{'value': '1198', 'groupId': 'OG000', 'lowerLimit': '1015', 'upperLimit': '1413'}, {'value': '1170', 'groupId': 'OG001', 'lowerLimit': '995', 'upperLimit': '1377'}, {'value': '962', 'groupId': 'OG002', 'lowerLimit': '809', 'upperLimit': '1143'}, {'value': '2186', 'groupId': 'OG003', 'lowerLimit': '1752', 'upperLimit': '2727'}]}]}, {'title': 'Anti-Pertusiss toxoid (N = 230, 235, 226, 119)', 'categories': [{'measurements': [{'value': '242', 'groupId': 'OG000', 'lowerLimit': '226', 'upperLimit': '260'}, {'value': '238', 'groupId': 'OG001', 'lowerLimit': '220', 'upperLimit': '258'}, {'value': '241', 'groupId': 'OG002', 'lowerLimit': '222', 'upperLimit': '262'}, {'value': '228', 'groupId': 'OG003', 'lowerLimit': '205', 'upperLimit': '254'}]}]}, {'title': 'Anti-FHA (N = 230, 234, 226, 118)', 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000', 'lowerLimit': '228', 'upperLimit': '259'}, {'value': '256', 'groupId': 'OG001', 'lowerLimit': '237', 'upperLimit': '277'}, {'value': '220', 'groupId': 'OG002', 'lowerLimit': '202', 'upperLimit': '239'}, {'value': '182', 'groupId': 'OG003', 'lowerLimit': '165', 'upperLimit': '200'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 150 (one month post-dose 3)', 'description': 'Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric Mean Titers were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV-HB-PRP~T Batch 1', 'description': 'Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'DTaP-IPV-HB-PRP~T Batch 2', 'description': 'Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG002', 'title': 'DTaP-IPV-HB-PRP~T Batch 3', 'description': 'Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'OG003', 'title': 'Infanrix Hexa™', 'description': 'Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Pain Post-dose 1 (N = 323, 336, 329, 155)', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '225', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pain Post-dose 2 (N = 310, 319, 316, 153)', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '199', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '88', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pain Pos-dose 3 (N = 302, 317, 306, 149)', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '198', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '87', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Erythema-Post dose 1 (N = 323, 336, 329, 156)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '97', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '41', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Erythema Post-dose 2 (N = 310, 319, 315, 153)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '96', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '33', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Erythema Post-dose 3 (N = 302, 317, 306, 149)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '101', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '43', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Swelling Post-dose 1 (N = 323, 336, 329, 156)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '80', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '35', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Swelling Post-dose 2 (N = 310, 319, 315, 153)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '60', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '26', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Swelling Post-dose 3 (N = 302, 317, 306, 149)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '72', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '22', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pyrexia Post-dose 1 (N = 323, 336, 329, 156)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '82', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '17', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pyrexia Post-dose 2 (N = 310, 318, 315, 153)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '85', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '32', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pyrexia Post-dose 3 (N = 302, 317, 306, 149)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '70', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '28', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Vomiting Post-dose 1 (N = 323, 336, 329, 156)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '56', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '27', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Vomiting Post-dose 2 (N = 310, 319, 316, 153)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '34', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Vomiting Post-dose 3 (N = 302, 317, 306, 149)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '47', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Crying Post-dose 1 (N = 323, 336, 329, 156)', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '148', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '62', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Crying Post-dose 2 (N=310, 319, 316, 153)', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '134', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '59', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Crying Post-dose 3 (N=302, 317, 306, 149)', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '122', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Somnolence Post-dose 1 (N = 323, 336, 329, 156)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '102', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '45', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Somnolence Post-dse 2 (N = 310, 319, 316, 153)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '65', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '24', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Somnolence Post-dose 3 (N = 302, 317, 306, 149)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '54', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Anorexia Post-dose 1 (N = 323, 336, 329, 156)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '70', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '27', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Anorexia Post-dose 2 (N = 310, 319, 315, 153)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '65', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '25', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Anorexia Post-dose 3 (N = 302, 317, 306, 149)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '65', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '29', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Irritability Post-dose 1 (N = 323, 336, 329, 156)', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '193', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '83', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Irritability Post-dose 2 (N = 310, 319, 316, 153)', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '174', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '72', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Irritability Post-dse 3 (N = 302, 317, 306, 149)', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '165', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '69', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-each vaccination) up to 7 days post-each dose', 'description': 'Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever (\\[pyrexia\\] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two batch 1 subjects got batch 2 vaccine, and 1 batch 1 got batch 3 vaccine. Total number (N) are those with available data for the outcome'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DTaP-IPV-HB-PRP~T Batch 1', 'description': 'Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'FG001', 'title': 'DTaP-IPV-HB-PRP~T Batch 2', 'description': 'Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'FG002', 'title': 'DTaP-IPV-HB-PRP~T Batch 3', 'description': 'Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'FG003', 'title': 'Infanrix Hexa™', 'description': 'Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '340'}, {'groupId': 'FG001', 'numSubjects': '343'}, {'groupId': 'FG002', 'numSubjects': '339'}, {'groupId': 'FG003', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '315'}, {'groupId': 'FG002', 'numSubjects': '294'}, {'groupId': 'FG003', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 14 November 2006 to 13 July 2007 in 6 clinical centers in Mexico.', 'preAssignmentDetails': 'A total of 1189 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'BG000'}, {'value': '343', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}, {'value': '1189', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'DTaP-IPV-HB-PRP~T Batch 1', 'description': 'Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'BG001', 'title': 'DTaP-IPV-HB-PRP~T Batch 2', 'description': 'Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'BG002', 'title': 'DTaP-IPV-HB-PRP~T Batch 3', 'description': 'Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T), with one dose each at 2, 4, and 6 months of age.'}, {'id': 'BG003', 'title': 'Infanrix Hexa™', 'description': 'Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '340', 'groupId': 'BG000'}, {'value': '343', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}, {'value': '1189', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'spread': '0.200', 'groupId': 'BG000'}, {'value': '2.00', 'spread': '0.197', 'groupId': 'BG001'}, {'value': '2.01', 'spread': '0.193', 'groupId': 'BG002'}, {'value': '1.98', 'spread': '0.189', 'groupId': 'BG003'}, {'value': '2.00', 'spread': '0.195', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '572', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '617', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '340', 'groupId': 'BG000'}, {'value': '343', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}, {'value': '1189', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-11', 'studyFirstSubmitDate': '2006-11-28', 'resultsFirstSubmitDate': '2014-02-14', 'studyFirstSubmitQcDate': '2006-11-28', 'lastUpdatePostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-11', 'studyFirstPostDateStruct': {'date': '2006-11-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine', 'timeFrame': 'Day 150 (one month post-dose 3)', 'description': 'Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.'}, {'measure': 'Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.', 'timeFrame': 'Day 150 (one month post-dose 3)', 'description': 'Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.'}, {'measure': 'Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine', 'timeFrame': 'Day 150 (one month post-dose 3)', 'description': 'Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine', 'timeFrame': 'Day 150 (one month post-dose 3)', 'description': 'Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).'}, {'measure': 'Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine', 'timeFrame': 'Day 0 (pre-each vaccination) up to 7 days post-each dose', 'description': 'Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever (\\[pyrexia\\] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diphtheria', 'Tetanus', 'Pertussis', 'Hepatitis B', 'Poliomyelitis', 'Invasive Haemophilus influenzae type b.'], 'conditions': ['Diphtheria', 'Tetanus', 'Pertussis', 'Hepatitis B', 'Poliomyelitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP\\~T vaccine is consistent.\n\nThe primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP\\~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.\n\nThe secondary objectives are:\n\n* To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series\n* To assess the overall safety in each group one month after the third dose of the primary series.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Two months old infants 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 one or both parents or by the guardian and two independent witnesses\n* Able to attend all scheduled visits and to comply with all trial procedures\n* Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.\n\nExclusion Criteria :\n\n* Participation in another clinical trial in the four weeks preceding the (first) trial vaccination\n* Planned participation in another clinical trial during the present trial period\n* Congenital or acquired immunodeficiency\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 since birth\n* Any vaccination in the four weeks preceding the first trial visit\n* Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study\n* Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)\n* Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)\n* Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity\n* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination\n* History of seizures\n* Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.'}, 'identificationModule': {'nctId': 'NCT00404651', 'briefTitle': 'Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants', 'orgStudyIdInfo': {'id': 'A3L11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Participants receive vaccine Batch A', 'interventionNames': ['Biological: DTaP-IPV-HB-PRP~T vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Participants receive vaccine Batch B', 'interventionNames': ['Biological: DTaP-IPV-HB-PRP~T vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Participants receive vaccine Batch C', 'interventionNames': ['Biological: DTaP-IPV-HB-PRP~T vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'description': 'Participants receive Infanrix hexa™', 'interventionNames': ['Biological: DTaP-HBV-IPV vaccine']}], 'interventions': [{'name': 'DTaP-IPV-HB-PRP~T vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, intramuscular (IM)', 'armGroupLabels': ['Group 1']}, {'name': 'DTaP-IPV-HB-PRP~T vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, IM', 'armGroupLabels': ['Group 2']}, {'name': 'DTaP-IPV-HB-PRP~T vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, IM', 'armGroupLabels': ['Group 3']}, {'name': 'DTaP-HBV-IPV vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['INFANRIX®HEXA'], 'description': '0.5 mL, IM', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56613', 'city': 'Estado de México', 'country': 'Mexico', 'geoPoint': {'lat': 18.01981, 'lon': -90.88107}}, {'city': 'Estado de México', 'country': 'Mexico', 'geoPoint': {'lat': 18.01981, 'lon': -90.88107}}, {'city': 'Insurgentes Cuicuilco', 'country': 'Mexico', 'geoPoint': {'lat': 19.30701, 'lon': -99.18332}}, {'city': 'Monterrey', 'country': 'Mexico', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'city': 'Puebla City', 'country': 'Mexico', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}, {'zip': '14050', 'city': 'Tlalpan', 'country': 'Mexico', 'geoPoint': {'lat': 19.29513, 'lon': -99.16206}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}