Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT00303316
Status:
COMPLETED
Last Update Posted:
2013-02-22
First Post:
2006-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean 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': 'D011051', 'term': 'Poliomyelitis'}, {'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': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C426945', 'term': 'Pentavac'}]}}, '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 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.', 'description': 'The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.', 'eventGroups': [{'id': 'EG000', 'title': 'DTacP-IPV-Hep B-PRP~T Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component \\[aP\\]), hepatitis B (Hep B \\[recombinant DNA\\]) and poliomyelitis (Inactivated \\[IPV\\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP\\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).', 'otherNumAtRisk': 231, 'otherNumAffected': 134, 'seriousNumAtRisk': 231, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'PENTAXIM™ and ENGERIX B® Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).', 'otherNumAtRisk': 223, 'otherNumAffected': 137, 'seriousNumAtRisk': 223, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Solicited Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 66, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 93, 'numAffected': 93}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Solicited Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 112, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 117, 'numAffected': 117}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Solicited Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 63, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 89, 'numAffected': 89}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 78, 'numAffected': 78}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 44, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 59, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 52, 'numAffected': 52}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 52, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 44, 'numAffected': 44}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 61, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 53, 'numAffected': 53}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'seriousEvents': [{'term': 'Otitis Media Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Febrile Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTacP-IPV-Hep B-PRP~T Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component \\[aP\\]), hepatitis B (Hep B \\[recombinant DNA\\]) and poliomyelitis (Inactivated \\[IPV\\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP\\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}, {'id': 'OG001', 'title': 'PENTAXIM™ and ENGERIX B® Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}], 'classes': [{'title': 'Anti-Hepatitis B (N = 228, 222)', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRP (N = 224, 217)', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria (N = 228, 221)', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus (N = 229, 216)', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 1 (N = 214, 205)', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2 (N = 217, 204)', 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3 (N = 214, 203)', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Pertussis Toxoid (N= 216, 212)', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Filamentous Hemagglutinin (N = 230, 220)', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (Before booster vaccination)', 'description': 'Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Antibody Persistence was assessed in all enrolled participants with pre-booster vaccination data (Intent-to-Treat population).'}, {'type': 'PRIMARY', 'title': 'Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTacP-IPV-Hep B-PRP~T Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component \\[aP\\]), hepatitis B (Hep B \\[recombinant DNA\\]) and poliomyelitis (Inactivated \\[IPV\\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP\\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}, {'id': 'OG001', 'title': 'PENTAXIM™ and ENGERIX B® Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}], 'classes': [{'title': 'Anti-PRP (N = 223, 216)', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria (N = 225, 221)', 'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus (N = 222, 219)', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 1 (N = 211, 209)', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2 (N = 208, 210)', 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3 (N = 205, 205)', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Pertussis Toxoid (N = 226, 220)', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Pertussis Toxoid (4-Fold Rise: N = 211, 208)', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Filamentous Hemagglutinin (N = 227, 221)', 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA (4-Fold Rise: N = 225, 215)', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 Post-booster Vaccination', 'description': 'Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster responses were assessed in all vaccinated participants with endpoint data following the booster vaccination (Intent-to-Treat population).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTacP-IPV-Hep B-PRP~T Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component \\[aP\\]), hepatitis B (Hep B \\[recombinant DNA\\]) and poliomyelitis (Inactivated \\[IPV\\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP\\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}, {'id': 'OG001', 'title': 'PENTAXIM™ and ENGERIX B® Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}], 'classes': [{'title': 'Injection site Pain', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection site Pain', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Injection site Erythema', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection site Erythema', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Injection site Swelling', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection site Swelling', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Any Pyrexia', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pyrexia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Crying', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Crying', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Somnolence', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Somnolence', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Anorexia', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Anorexia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 30 post-booster vaccination', 'description': 'Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.\n\nGrade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, \\> 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, Safety Analysis Set population.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTacP-IPV-Hep B-PRP~T Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component \\[aP\\]), hepatitis B (Hep B \\[recombinant DNA\\]) and poliomyelitis (Inactivated \\[IPV\\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP\\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}, {'id': 'OG001', 'title': 'PENTAXIM™ and ENGERIX B® Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}], 'classes': [{'title': 'Anti-Hepatitis B Pre-booster (N = 228, 222)', 'categories': [{'measurements': [{'value': '87.6', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '111'}, {'value': '197', 'groupId': 'OG001', 'lowerLimit': '168', 'upperLimit': '230'}]}]}, {'title': 'Anti-PRP Pre-booster (N = 224, 217)', 'categories': [{'measurements': [{'value': '0.399', 'groupId': 'OG000', 'lowerLimit': '0.327', 'upperLimit': '0.487'}, {'value': '0.326', 'groupId': 'OG001', 'lowerLimit': '0.270', 'upperLimit': '0.394'}]}]}, {'title': 'Anti-PRP Post-booster (N = 223, 216)', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '32.7'}, {'value': '41.4', 'groupId': 'OG001', 'lowerLimit': '35.0', 'upperLimit': '48.8'}]}]}, {'title': 'Anti-Diphtheria Pre-booster (N = 228, 221)', 'categories': [{'measurements': [{'value': '0.022', 'groupId': 'OG000', 'lowerLimit': '0.018', 'upperLimit': '0.027'}, {'value': '0.018', 'groupId': 'OG001', 'lowerLimit': '0.015', 'upperLimit': '0.022'}]}]}, {'title': 'Anti-Diphtheria Post-booster (N = 225, 221)', 'categories': [{'measurements': [{'value': '1.92', 'groupId': 'OG000', 'lowerLimit': '1.58', 'upperLimit': '2.32'}, {'value': '2.11', 'groupId': 'OG001', 'lowerLimit': '1.74', 'upperLimit': '2.56'}]}]}, {'title': 'Anti-Tetanus Pre-booster (N = 229, 216)', 'categories': [{'measurements': [{'value': '0.287', 'groupId': 'OG000', 'lowerLimit': '0.255', 'upperLimit': '0.325'}, {'value': '0.171', 'groupId': 'OG001', 'lowerLimit': '0.153', 'upperLimit': '0.192'}]}]}, {'title': 'Anti-Tetanus Post-booster (N = 222, 219)', 'categories': [{'measurements': [{'value': '4.81', 'groupId': 'OG000', 'lowerLimit': '4.37', 'upperLimit': '5.31'}, {'value': '4.54', 'groupId': 'OG001', 'lowerLimit': '4.07', 'upperLimit': '5.08'}]}]}, {'title': 'Anti-Polio 1 Pre-booster (N= 214, 205)', 'categories': [{'measurements': [{'value': '303', 'groupId': 'OG000', 'lowerLimit': '251', 'upperLimit': '365'}, {'value': '232', 'groupId': 'OG001', 'lowerLimit': '193', 'upperLimit': '279'}]}]}, {'title': 'Anti-Polio 1 Post-booster (N = 211, 209)', 'categories': [{'measurements': [{'value': '7243', 'groupId': 'OG000', 'lowerLimit': '6218', 'upperLimit': '8436'}, {'value': '9996', 'groupId': 'OG001', 'lowerLimit': '8521', 'upperLimit': '11725'}]}]}, {'title': 'Anti-Polio 2 Pre-booster (N = 217, 204)', 'categories': [{'measurements': [{'value': '370', 'groupId': 'OG000', 'lowerLimit': '300', 'upperLimit': '457'}, {'value': '292', 'groupId': 'OG001', 'lowerLimit': '234', 'upperLimit': '366'}]}]}, {'title': 'Anti-Polio 2 Post-booster (N = 208, 210)', 'categories': [{'measurements': [{'value': '8512', 'groupId': 'OG000', 'lowerLimit': '7281', 'upperLimit': '9952'}, {'value': '11229', 'groupId': 'OG001', 'lowerLimit': '9574', 'upperLimit': '13170'}]}]}, {'title': 'Anti-Polio 3 Pre-booster (N = 214, 203)', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000', 'lowerLimit': '202', 'upperLimit': '327'}, {'value': '223', 'groupId': 'OG001', 'lowerLimit': '174', 'upperLimit': '284'}]}]}, {'title': 'Anti-Polio 3 Post-booster (N = 205, 205)', 'categories': [{'measurements': [{'value': '10975', 'groupId': 'OG000', 'lowerLimit': '9066', 'upperLimit': '13286'}, {'value': '14482', 'groupId': 'OG001', 'lowerLimit': '12067', 'upperLimit': '17380'}]}]}, {'title': 'Anti-PT Pre-booster (N = 216, 212)', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '9.37', 'upperLimit': '12.3'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '14.7'}]}]}, {'title': 'Anti-PT Post-booster (N = 226, 220)', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000', 'lowerLimit': '205', 'upperLimit': '249'}, {'value': '325', 'groupId': 'OG001', 'lowerLimit': '292', 'upperLimit': '362'}]}]}, {'title': 'Anti-FHA Pre-booster (N = 230, 220)', 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '32.5'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '21.6'}]}]}, {'title': 'Anti-FHA Post-booster (N = 227, 221)', 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000', 'lowerLimit': '305', 'upperLimit': '368'}, {'value': '333', 'groupId': 'OG001', 'lowerLimit': '305', 'upperLimit': '363'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-booster) and Day 30 post-booster', 'description': 'Antibody titers determination:\n\nHepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers were assessed in all participants with endpoint data who received the booster vaccine (Intent-to-Treat Analysis Set for immunogenicity).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DTacP-IPV-Hep B-PRP~T Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component \\[aP\\]), hepatitis B (Hep B \\[recombinant DNA\\]) and poliomyelitis (Inactivated \\[IPV\\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP\\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}, {'id': 'FG001', 'title': 'PENTAXIM™ and ENGERIX B® Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '226'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 15 February 2006 to 03 October 2006 at 1 clinical center in Argentina.', 'preAssignmentDetails': 'A total of 458 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DTacP-IPV-Hep B-PRP~T Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component \\[aP\\]), hepatitis B (Hep B \\[recombinant DNA\\]) and poliomyelitis (Inactivated \\[IPV\\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP\\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}, {'id': 'BG001', 'title': 'PENTAXIM™ and ENGERIX B® Group', 'description': 'Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '0.436', 'groupId': 'BG000'}, {'value': '17.7', 'spread': '0.492', 'groupId': 'BG001'}, {'value': '17.6', 'spread': '0.465', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 458}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-18', 'studyFirstSubmitDate': '2006-03-13', 'resultsFirstSubmitDate': '2012-12-11', 'studyFirstSubmitQcDate': '2006-03-13', 'lastUpdatePostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-18', 'studyFirstPostDateStruct': {'date': '2006-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.', 'timeFrame': 'Day 0 (Before booster vaccination)', 'description': 'Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).'}, {'measure': 'Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.', 'timeFrame': 'Day 30 Post-booster Vaccination', 'description': 'Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.'}, {'measure': 'Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.', 'timeFrame': 'Day 0 (pre-booster) and Day 30 post-booster', 'description': 'Antibody titers determination:\n\nHepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™', 'timeFrame': 'Day 0 up to Day 30 post-booster vaccination', 'description': 'Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.\n\nGrade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, \\> 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable.'}]}, 'conditionsModule': {'keywords': ['Diphtheria', 'Tetanus', 'Pertussis', 'whooping cough', 'Haemophilus influenzae type b', 'Hepatitis B', 'Poliomyelitis'], 'conditions': ['Diphtheria', 'Tetanus', 'Pertussis', 'Poliomyelitis', 'Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '22157567', 'type': 'RESULT', 'citation': 'Tregnaghi M, Zambrano B, Santos-Lima E. Antibody persistence after a primary series of a new DTaP-IPV-Hep B-PRP-T combined vaccine or separate DTaP-IPV//PRP-T and hepatitis B vaccines at 2, 4, and 6 months of age and the effect of a subsequent DTaP-IPV//PRP-T booster vaccination at 18 months of age in healthy Argentinean infants. Pediatr Infect Dis J. 2012 Jan;31(1):e24-30. doi: 10.1097/INF.0b013e318242460a.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series.\n\nPrimary Objective:\n\nTo describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity.\n\nSecondary objective:\n\nTo describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '578 Days', 'minimumAge': '510 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Toddler at 18 months of age (range: 510 days to 578 days of age inclusive)\n* Participated in study A3L02 (NCT00831311) and has completed the three-dose primary series with either diphtheria, tetanus, pertussis (2-component acellular), recombinant Hepatitis B Hansenula and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\\~T) or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age\n* Written informed consent form signed by at least one parent or by a legal representative and an independent witness\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 four 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 anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroids therapy\n* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances\n* Chronic illness at a stage that could interfere with trial conduct or completion\n* Blood or blood-derived products received in the last six months\n* Any vaccination in the four weeks preceding the trial\n* Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B antigen, since the end of the primary series\n* History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B infection(s) (confirmed either clinically, serologically, or microbiologically)\n* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination\n* History of seizures\n* Fever (axillary temperature ≥37.4°C or equivalent rectal temperature ≥38.0°C) or acute illness on the day of inclusion\n* Known contraindication to further vaccination with a pertussis vaccine such as:\n* Encephalopathy; Inconsolable crying for \\>3 hours within 48 hours following vaccine injection\n* Hypotonic hyporesponsive episode within 48 hours following vaccine injection\n* Seizures with or without fever within three days following vaccine injection\n* Axillary temperature \\>39.4°C or equivalent rectal temperature \\> 40.0°C within 48 hours following vaccine injection.'}, 'identificationModule': {'nctId': 'NCT00303316', 'briefTitle': 'Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity Study of the Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months of Age Following a Primary Series of DTaP-IPV-HB-PRP~T Combined Vaccine or of PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants', 'orgStudyIdInfo': {'id': 'A3L16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DTacP IPV HepB PRP-T Combined Vaccine Group', 'description': 'Participant will receive a booster dose of PENTAXIM™ having received DTacP-IPV-HepB-PRP-T (primary series) in Study A3L02.', 'interventionNames': ['Biological: DTaP-IPV//PRP~T combined vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PENTAXIM™ and ENGERIX B® Vaccine Group', 'description': 'Participant will receive a booster dose of PENTAXIM™ having received ENGERIX B® and PEDIATRICO in Study A3L02 (Primary series)', 'interventionNames': ['Biological: DTaP-IPV//PRP~T combined vaccine']}], 'interventions': [{'name': 'DTaP-IPV//PRP~T combined vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['PENTAXIM™'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['DTacP IPV HepB PRP-T Combined Vaccine Group']}, {'name': 'DTaP-IPV//PRP~T combined vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['PENTAXIM™'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['PENTAXIM™ and ENGERIX B® Vaccine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Córdoba', 'state': 'Córdoba Province', 'country': 'Argentina', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}