Viewing Study NCT01346293

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Study NCT ID: NCT01346293
Status: COMPLETED
Last Update Posted: 2015-06-03
First Post: 2011-04-29
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D008457', 'term': 'Measles'}, {'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium 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': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales 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': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae 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': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022681', 'term': 'Diphtheria-Tetanus-acellular Pertussis Vaccines'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D010567', 'term': 'Pertussis Vaccine'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D004168', 'term': 'Diphtheria Toxoid'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D022282', 'term': 'Vaccines, Acellular'}, {'id': 'D022223', 'term': 'Vaccines, Subunit'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination', 'description': 'The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.', 'eventGroups': [{'id': 'EG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly', 'otherNumAtRisk': 2733, 'otherNumAffected': 2081, 'seriousNumAtRisk': 2733, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®', 'otherNumAtRisk': 621, 'otherNumAffected': 461, 'seriousNumAtRisk': 621, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 142, 'numAffected': 139}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 147, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2689, 'numEvents': 2081, 'numAffected': 2081}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 461, 'numAffected': 461}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2687, 'numEvents': 1587, 'numAffected': 1587}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 322, 'numAffected': 322}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2678, 'numEvents': 1076, 'numAffected': 1076}, {'groupId': 'EG001', 'numAtRisk': 602, 'numEvents': 219, 'numAffected': 219}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Change in limb circumference', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2500, 'numEvents': 1703, 'numAffected': 1703}, {'groupId': 'EG001', 'numAtRisk': 464, 'numEvents': 302, 'numAffected': 302}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2668, 'numEvents': 161, 'numAffected': 161}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 41, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2688, 'numEvents': 419, 'numAffected': 419}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 100, 'numAffected': 100}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2687, 'numEvents': 940, 'numAffected': 940}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 200, 'numAffected': 200}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2688, 'numEvents': 1445, 'numAffected': 1445}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 317, 'numAffected': 317}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Immunodeficiency common variable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Autism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Petit mal epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 621, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Anti-Pertussis toxoid (N=252, 247)', 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Filamentous hemagglutinin (N=255, 248)', 'categories': [{'measurements': [{'value': '242', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Pertactin (N=254, 248)', 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Fimbriae types 2 and 3 (N=250, 249)', 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '0.7', 'ciUpperLimit': '10.2', 'groupDescription': 'Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% Confidence intervals (CIs) of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Pertussis toxoid antigen between groups were \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.4', 'ciLowerLimit': '2.5', 'ciUpperLimit': '21.5', 'groupDescription': 'Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Filamentous Haemagglutinin between groups were \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '3.7', 'paramValue': '3.7', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '7.9', 'groupDescription': 'Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for the Pertactin antigens between groups were \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.8', 'ciLowerLimit': '0.9', 'ciUpperLimit': '9.1', 'groupDescription': 'Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Fimbriae types 2 and 3 antigens between groups were \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Booster responses to pertussis antigens \\[pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)\\] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (\\<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but \\<4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Anti-PT pre-vaccination (N=254, 248)', 'categories': [{'measurements': [{'value': '5.16', 'groupId': 'OG000', 'lowerLimit': '4.48', 'upperLimit': '5.94'}, {'value': '4.74', 'groupId': 'OG001', 'lowerLimit': '4.18', 'upperLimit': '5.39'}]}]}, {'title': 'Anti-PT post-vaccination (N=261, 252)', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '134'}, {'value': '61.3', 'groupId': 'OG001', 'lowerLimit': '54.5', 'upperLimit': '68.9'}]}]}, {'title': 'Anti-FHA pre-vaccination (N=255, 248)', 'categories': [{'measurements': [{'value': '7.93', 'groupId': 'OG000', 'lowerLimit': '6.63', 'upperLimit': '9.47'}, {'value': '9.42', 'groupId': 'OG001', 'lowerLimit': '7.85', 'upperLimit': '11.3'}]}]}, {'title': 'Anti-FHA post-vaccination (N=263, 253)', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '141'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '69.3', 'upperLimit': '90.0'}]}]}, {'title': 'Anti-PRN pre-vaccination (N=255, 249)', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '21.3'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '19.1'}]}]}, {'title': 'Anti-PRN post-vaccination (N=262, 252)', 'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000', 'lowerLimit': '252', 'upperLimit': '317'}, {'value': '187', 'groupId': 'OG001', 'lowerLimit': '164', 'upperLimit': '214'}]}]}, {'title': 'Anti-FIM pre-vaccination (N=253, 249)', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '37.6'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '28.3', 'upperLimit': '39.2'}]}]}, {'title': 'Anti-FIM post-vaccination (N=260, 253)', 'categories': [{'measurements': [{'value': '506', 'groupId': 'OG000', 'lowerLimit': '448', 'upperLimit': '571'}, {'value': '379', 'groupId': 'OG001', 'lowerLimit': '331', 'upperLimit': '433'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '1.68', 'ciUpperLimit': '2.31', 'groupDescription': 'Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each Pertussis antigen and their 2-sided 95% Confidence Intervals.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertussis Toxoid antigens between groups were \\> 2/3.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '1.30', 'ciUpperLimit': '1.88', 'groupDescription': 'Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Filamentous Haemagglutinin antigens between groups were \\> 2/3.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '1.27', 'ciUpperLimit': '1.79', 'groupDescription': 'Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertactin antigens between groups were \\> 2/3.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '1.12', 'ciUpperLimit': '1.60', 'groupDescription': 'Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL® ) in post-vaccination GMCs for the Fimbriae types 2 and 3 antigens between groups were \\> 2/3.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Geometric mean concentrations to pertussis antigens (pertussis toxoid \\[PT\\], filamentous hemagglutinin \\[FHA\\], pertactin \\[PRN\\], and fimbriae types 2 and 3 \\[FIM\\]) were measured by enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean concentrations were assessed in the Per-Protocol Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Anti-Tetanus (N=253, 248)', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria (N=256, 249)', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration \\<0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but \\<2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Anti-Tetanus and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Anti-Tetanus pre-vaccination (N=254, 248)', 'categories': [{'measurements': [{'value': '0.644', 'groupId': 'OG000', 'lowerLimit': '0.548', 'upperLimit': '0.758'}, {'value': '0.608', 'groupId': 'OG001', 'lowerLimit': '0.518', 'upperLimit': '0.715'}]}]}, {'title': 'Anti-Tetanus post-vaccination (N=262, 253)', 'categories': [{'measurements': [{'value': '6.42', 'groupId': 'OG000', 'lowerLimit': '5.74', 'upperLimit': '7.18'}, {'value': '5.48', 'groupId': 'OG001', 'lowerLimit': '4.88', 'upperLimit': '6.15'}]}]}, {'title': 'Anti-Diphtheria pre-vaccination (N=257, 249)', 'categories': [{'measurements': [{'value': '0.510', 'groupId': 'OG000', 'lowerLimit': '0.437', 'upperLimit': '0.596'}, {'value': '0.426', 'groupId': 'OG001', 'lowerLimit': '0.362', 'upperLimit': '0.501'}]}]}, {'title': 'Anti-Diphtheria post-vaccination (N=262, 253)', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '20.8'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '17.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean concentrations of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Anti-Polio 1 (N=249, 248)', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2 (N=249, 248)', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3 (N=247, 248)', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration \\<1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Anti-polio booster responses were assessed in the Per-Protocol Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Anti-Polio 1 pre-vaccination (N=254, 248)', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000', 'lowerLimit': '114', 'upperLimit': '160'}, {'value': '129', 'groupId': 'OG001', 'lowerLimit': '110', 'upperLimit': '151'}]}]}, {'title': 'Anti-Polio 1 post-vaccination (N=258, 253)', 'categories': [{'measurements': [{'value': '3477', 'groupId': 'OG000', 'lowerLimit': '3088', 'upperLimit': '3915'}, {'value': '2731', 'groupId': 'OG001', 'lowerLimit': '2384', 'upperLimit': '3128'}]}]}, {'title': 'Anti-Polio 2 pre-vaccination (N=254, 248)', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000', 'lowerLimit': '183', 'upperLimit': '249'}, {'value': '188', 'groupId': 'OG001', 'lowerLimit': '160', 'upperLimit': '221'}]}]}, {'title': 'Anti-Polio 2 post-vaccination (N=258, 253)', 'categories': [{'measurements': [{'value': '3491', 'groupId': 'OG000', 'lowerLimit': '3111', 'upperLimit': '3917'}, {'value': '3894', 'groupId': 'OG001', 'lowerLimit': '3393', 'upperLimit': '4468'}]}]}, {'title': 'Anti-Polio 3 pre-vaccination (N=252, 248)', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '123'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '74.5', 'upperLimit': '111'}]}]}, {'title': 'Anti-Polio 3 post-vaccination (N=258, 252)', 'categories': [{'measurements': [{'value': '4591', 'groupId': 'OG000', 'lowerLimit': '4011', 'upperLimit': '5256'}, {'value': '3419', 'groupId': 'OG001', 'lowerLimit': '2946', 'upperLimit': '3969'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean concentrations of poliovirus antibodies were assessed in the Per-Protocol Analysis Set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Anti-Tetanus pre-vacc. ≥0.1 IU/ml (N=254, 248)', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus pre-vacc. ≥1.0 IU/ml (N=254, 248)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus post-vacc. ≥0.1 IU/ml (N=262, 253)', 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus post-vacc. ≥1.0 IU/ml (N=262, 253)', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria pre-vacc. ≥0.1 IU/ml (N=257, 249)', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria pre-vacc. ≥1.0 IU/ml (N=257, 249)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria post-vacc. ≥0.1 IU/ml (N=262, 253)', 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria post-vacc. ≥1.0 IU/ml (N=262, 253)', 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Anti-Tetanus antibodies were measured by ELISA. Anti diphtheria antibodies were measured by a toxin neutralization test. Seroprotection for anti-tetanus and anti-diphtheria was defined as antibody concentrations ≥0.1 IU/ml and ≥1.0 IU/ml.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Anti-Polio 1 pre-vaccination (N=254, 248)', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 1 post-vaccinatin (N=258, 253)', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2 pre-vaccination (N=254, 248)', 'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2 post-vaccination (N=258, 253)', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3 pre-vaccination (N=252, 248)', 'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3 post-vaccination (N=258, 252)', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection for anti-polio types was defined as antibody titers ≥1:8 dilution.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Anti-Polio 1 4th dose (N=238, 235)', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 1 5th dose (N=10, 12)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2 4th dose (N=238, 235)', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2 5th dose (N=10, 12)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3 4th dose (N=236, 235)', 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3 5th dose (N=10, 12)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Four-fold rise in booster responses between groups was defined as post/pre-vaccination ≥4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Anti-Polio 1 pre-4th dose (N=243, 235)', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '159'}, {'value': '123', 'groupId': 'OG001', 'lowerLimit': '105', 'upperLimit': '144'}]}]}, {'title': 'Anti-Polio 1 post-4th dose (N=247, 240)', 'categories': [{'measurements': [{'value': '3471', 'groupId': 'OG000', 'lowerLimit': '3072', 'upperLimit': '3921'}, {'value': '2774', 'groupId': 'OG001', 'lowerLimit': '2420', 'upperLimit': '3179'}]}]}, {'title': 'Anti-Polio 1 pre-5th dose (N=10, 12)', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000', 'lowerLimit': '70.6', 'upperLimit': '533'}, {'value': '342', 'groupId': 'OG001', 'lowerLimit': '131', 'upperLimit': '890'}]}]}, {'title': 'Anti-Polio 1 post-5th dose (N=10, 12)', 'categories': [{'measurements': [{'value': '3327', 'groupId': 'OG000', 'lowerLimit': '1769', 'upperLimit': '6256'}, {'value': '1773', 'groupId': 'OG001', 'lowerLimit': '692', 'upperLimit': '4543'}]}]}, {'title': 'Anti-Polio 2 pre-4th dose (N=243, 235)', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000', 'lowerLimit': '179', 'upperLimit': '246'}, {'value': '181', 'groupId': 'OG001', 'lowerLimit': '153', 'upperLimit': '213'}]}]}, {'title': 'Anti-Polio 2 post-4th dose (N=247, 240)', 'categories': [{'measurements': [{'value': '3495', 'groupId': 'OG000', 'lowerLimit': '3117', 'upperLimit': '3920'}, {'value': '3991', 'groupId': 'OG001', 'lowerLimit': '3470', 'upperLimit': '4590'}]}]}, {'title': 'Anti-Polio 2 pre-5th dose (N=10, 12)', 'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000', 'lowerLimit': '135', 'upperLimit': '558'}, {'value': '431', 'groupId': 'OG001', 'lowerLimit': '166', 'upperLimit': '1119'}]}]}, {'title': 'Anti-Polio 2 post-5th dose (N=10, 12)', 'categories': [{'measurements': [{'value': '3566', 'groupId': 'OG000', 'lowerLimit': '1205', 'upperLimit': '10554'}, {'value': '2048', 'groupId': 'OG001', 'lowerLimit': '1002', 'upperLimit': '4187'}]}]}, {'title': 'Anti-Polio 3 pre-4th dose (N=241, 235)', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '121'}, {'value': '86.3', 'groupId': 'OG001', 'lowerLimit': '70.6', 'upperLimit': '106'}]}]}, {'title': 'Anti-Polio 3 post-4th dose (N=247, 239)', 'categories': [{'measurements': [{'value': '4773', 'groupId': 'OG000', 'lowerLimit': '4168', 'upperLimit': '5466'}, {'value': '3500', 'groupId': 'OG001', 'lowerLimit': '3007', 'upperLimit': '4075'}]}]}, {'title': 'Anti-Polio 3 pre-5th dose (N=10, 12)', 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000', 'lowerLimit': '137', 'upperLimit': '417'}, {'value': '323', 'groupId': 'OG001', 'lowerLimit': '139', 'upperLimit': '748'}]}]}, {'title': 'Anti-Polio 3 post-5th dose (N=10, 12)', 'categories': [{'measurements': [{'value': '1663', 'groupId': 'OG000', 'lowerLimit': '687', 'upperLimit': '4026'}, {'value': '2436', 'groupId': 'OG001', 'lowerLimit': '1033', 'upperLimit': '5744'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination', 'description': 'Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Anti-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2733', 'groupId': 'OG000'}, {'value': '621', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'OG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'classes': [{'title': 'Injection-site Pain (N=2689, 603)', 'categories': [{'measurements': [{'value': '2081', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Pain (N=2689, 603)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Erythema (N=2687, 603)', 'categories': [{'measurements': [{'value': '1587', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Erythema (N=2687, 603)', 'categories': [{'measurements': [{'value': '484', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Swelling (N=2678, 602)', 'categories': [{'measurements': [{'value': '1076', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Swelling (N=2678, 602)', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Extensive limb swelling (N=2666, 598)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Extensive limb swelling (N=2666, 598)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Change in limb circumference (N=2500, 464)', 'categories': [{'measurements': [{'value': '1703', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Change in limb circumference (N=2500, 464)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever (N=2668, 598)', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (N=2668, 598)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Headache (N=2688, 603)', 'categories': [{'measurements': [{'value': '419', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (N=2688, 603)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Malaise (N=2687, 603)', 'categories': [{'measurements': [{'value': '940', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (N=2687, 603)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia (N=2688, 603)', 'categories': [{'measurements': [{'value': '1445', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (N=2688, 603)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 28 post-final vaccination', 'description': 'Solicited injection-site: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb, Change in Limb Circumference. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, ≥50 mm; Change in limb circumference \\>50 mm increase over pre-vaccination measurement; Extensive limb swelling (ELS) was considered severe. Grade 3 systemic reactions: Fever ≥39.0˚C; Headache, Malaise, and Myalgia Significant, prevents daily activity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'FG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2743'}, {'groupId': 'FG001', 'numSubjects': '629'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2676'}, {'groupId': 'FG001', 'numSubjects': '608'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study participants were enrolled from 28 April to 16 November 2012 at 70 clinic sites in the United States and Puerto Rico.', 'preAssignmentDetails': 'A total of 3372 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2743', 'groupId': 'BG000'}, {'value': '629', 'groupId': 'BG001'}, {'value': '3372', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DTaP-IPV', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly'}, {'id': 'BG001', 'title': 'DAPTACEL®+IPOL®', 'description': 'Children ≥4 to \\<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2743', 'groupId': 'BG000'}, {'value': '629', 'groupId': 'BG001'}, {'value': '3372', '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': '4.4', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '4.4', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '4.4', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1330', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '1636', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1413', 'groupId': 'BG000'}, {'value': '323', 'groupId': 'BG001'}, {'value': '1736', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2743', 'groupId': 'BG000'}, {'value': '629', 'groupId': 'BG001'}, {'value': '3372', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3372}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2013-11-18', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-28', 'studyFirstSubmitDate': '2011-04-29', 'dispFirstSubmitQcDate': '2013-11-18', 'resultsFirstSubmitDate': '2015-04-23', 'studyFirstSubmitQcDate': '2011-04-29', 'dispFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-27', 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Anti-Tetanus antibodies were measured by ELISA. Anti diphtheria antibodies were measured by a toxin neutralization test. Seroprotection for anti-tetanus and anti-diphtheria was defined as antibody concentrations ≥0.1 IU/ml and ≥1.0 IU/ml.'}, {'measure': 'Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection for anti-polio types was defined as antibody titers ≥1:8 dilution.'}, {'measure': 'Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Four-fold rise in booster responses between groups was defined as post/pre-vaccination ≥4.'}, {'measure': 'Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose', 'timeFrame': 'Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination', 'description': 'Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.'}, {'measure': 'Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'timeFrame': 'Day 0 up to Day 28 post-final vaccination', 'description': 'Solicited injection-site: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb, Change in Limb Circumference. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, ≥50 mm; Change in limb circumference \\>50 mm increase over pre-vaccination measurement; Extensive limb swelling (ELS) was considered severe. Grade 3 systemic reactions: Fever ≥39.0˚C; Headache, Malaise, and Myalgia Significant, prevents daily activity.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Booster responses to pertussis antigens \\[pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)\\] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (\\<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but \\<4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.'}, {'measure': 'Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Geometric mean concentrations to pertussis antigens (pertussis toxoid \\[PT\\], filamentous hemagglutinin \\[FHA\\], pertactin \\[PRN\\], and fimbriae types 2 and 3 \\[FIM\\]) were measured by enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration \\<0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but \\<2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.'}, {'measure': 'Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration \\<1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.'}, {'measure': 'Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tetanus', 'Diphtheria', 'Pertussis', 'DTap-IPV', 'DAPTACEL®', 'VARIVAX®'], 'conditions': ['Tetanus', 'Diphtheria', 'Pertussis', 'Measles', 'Polio']}, 'referencesModule': {'references': [{'pmid': '27879555', 'type': 'DERIVED', 'citation': 'Smith MJ, Jordanov E, Sheng X, Tsang PH. Safety and Immunogenicity of DTaP5-IPV Compared With DTaP5 Plus IPV as the Fifth Dose in Children 4-6 Years of Age. Pediatr Infect Dis J. 2017 Mar;36(3):319-325. doi: 10.1097/INF.0000000000001427.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to \\< 7 years of age in the US and Puerto Rico who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only.\n\nPrimary Objectives:\n\n* To compare the pertussis \\[Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)\\] booster responses and geometric mean concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay \\[ELISA\\]) following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination when administered as a 5th dose.\n* To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations when administered as a 5th dose .\n* To compare the Inactivated Poliovirus Vaccine booster responses (as measured by neutralizing assay) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.\n\nObservational Objectives:\n\n* To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.\n* To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL and/or Pentacel vaccines.', 'detailedDescription': 'All participants will be randomized to receive either one dose each of DTap-IPV + Measles, Mumps, and Rubella Virus Vaccine Live (M-M-R®II) + VARIVAX® or one dose each of DAPTACEL® + IPOL® + M-M-R®II + VARIVAX® on Day 0.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged ≥ 4 to \\< 7 years on the day of inclusion\n* Informed consent form has been signed and dated by the parent/guardian before the first study-related procedure\n* Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures\n* Subject has documented completion of primary infant series and booster with DAPTACEL® and/or Pentacel® vaccine(s) only.\n\nExclusion Criteria:\n\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination\n* Planned participation in another clinical trial during the present trial period\n* Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for any influenza vaccine, which may be received at least 2 weeks before study vaccines\n* Planned receipt of any vaccine in the 4 weeks following the trial vaccination except for any influenza vaccine, which may be received at least 2 weeks after study vaccines\n* Receipt of blood or blood-derived products in the past 3 months\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\n* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C\n* History of diphtheria, tetanus, or pertussis infection, confirmed either clinically, serologically, or microbiologically\n* Known systemic hypersensitivity to any of the vaccines' components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances\n* Laboratory-confirmed thrombocytopenia, contraindicating intramuscular vaccination\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination\n* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion\n* Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the investigator."}, 'identificationModule': {'nctId': 'NCT01346293', 'briefTitle': 'Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of DTap-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined With Inactivated Poliovirus Vaccine) Compared to DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL® (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age', 'orgStudyIdInfo': {'id': 'M5I02'}, 'secondaryIdInfos': [{'id': 'U1111-1116-4842', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group 1', 'description': 'Participants will receive concomitantly a dose of DTap-IPV, a dose of M-M-R®II, and a dose of VARIVAX® vaccine on Day 0', 'interventionNames': ['Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group 2', 'description': 'Participants will receive concomitantly a dose of DAPTACEL®, a dose of IPOL®, a dose of M-M-R®II, and a dose of VARIVAX® vaccines on Day 0', 'interventionNames': ['Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + 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