Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-08 @ 3:41 PM
Study NCT ID:
NCT00258895
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2005-11-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022681', 'term': 'Diphtheria-Tetanus-acellular Pertussis Vaccines'}], 'ancestors': [{'id': 'D010567', 'term': 'Pertussis Vaccine'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004168', 'term': 'Diphtheria Toxoid'}, {'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D013745', 'term': 'Tetanus 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 events data were collected from the day of vaccination for 6 months post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'DAPTACEL®-Primed', 'description': 'Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.', 'otherNumAtRisk': 487, 'otherNumAffected': 62, 'seriousNumAtRisk': 487, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Pentacel®-Primed', 'description': 'Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.', 'otherNumAtRisk': 162, 'otherNumAffected': 55, 'seriousNumAtRisk': 162, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Injection site redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Otitis media NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Upper respiratory tract infection NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}], 'seriousEvents': [{'term': 'Thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Gastroenteritis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Otitis media NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Skull fracture NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Staring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Asthma NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Bronchospasm NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 487, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DAPTACEL®-Primed', 'description': 'Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.'}, {'id': 'OG001', 'title': 'Pentacel®-Primed', 'description': 'Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.'}], 'classes': [{'title': 'Any Solicited Local Reaction - Dose 5', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness (> 5 mm)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness (> 50 mm)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling (> 5 mm)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling (> 50 mm)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Tenderness (Incapacitating)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Change in Limb Circumference (> 5 mm)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Change in Limb Circumference (> 40 mm)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Functional Impairment', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Functional Impairment (Incapacitating)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic Reaction - Dose 5', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever (≥ 38.0 ºC)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (> 39.5 ºC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability (Incapacitating)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Crying', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Crying (Incapacitating)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Lethargy', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Lethargy (Incapacitating)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Anorexia', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Anorexia (skipped 2 meals)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Vomiting (per 24 hours)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Vomiting (≥ 3 episodes)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Diarrhea (per 24 hours)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Diarrhea (> 5 diarrhea stools)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 7 days Post-Dose 5', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DAPTACEL®-Primed', 'description': 'Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.'}, {'id': 'OG001', 'title': 'Pentacel®-Primed', 'description': 'Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.'}], 'classes': [{'title': 'Anti-Pertussis (EU/mL)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Filamentous Haemagglutinin (EU/mL)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Fimbriae Types 2 and 3 (EU/mL)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Pertactin (EU/mL)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 to 48 Post-dose 5', 'description': 'Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The anti-Pertussis 4-fold rises were evaluated in the per-protocol immunology population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DAPTACEL®-Primed', 'description': 'Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.'}, {'id': 'OG001', 'title': 'Pentacel®-Primed', 'description': 'Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.'}], 'classes': [{'title': 'Anti-Pertussis (EU/mL)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Fillamentous Haemagglutinin (EU/mL)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Fimbriae Types 2 and 3 (EU/mL)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Pertactin (EU/mL)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 to 48 Post-Dose 5', 'description': 'Booster response calculation: If pre-Dose 5 titer \\< 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The anti-pertussis booster response was assessed in the per-protocol immunogenicity population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DAPTACEL®-Primed', 'description': 'Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.'}, {'id': 'OG001', 'title': 'Pentacel®-Primed', 'description': 'Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.'}], 'classes': [{'title': 'Anti-Diphtheria (IU/mL) ≥ 0.01 Pre-dose 5', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria (IU/mL) ≥ 0.1 Pre-dose 5', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diptheria (IU/mL) ≥ 1.0 Pre-dose 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria (IU/mL) ≥ 0.1 Post-dose 5', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria (IU/mL) ≥ 1.0 Post-dose 5', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus (IU/mL) ≥ 0.01 Pre-dose 5', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus (IU/mL) ≥ 0.1 Pre-dose 5', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus (IU/mL) ≥ 1.0 Pre-dose 5', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus (IU/mL) ≥ 0.1 Post-dose 5', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus (IU/mL) ≥ 1.0 Post-dose 5', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 and between Days 28-48 Post-dose 5', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Antibody responses were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DAPTACEL®-Primed', 'description': 'Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.'}, {'id': 'OG001', 'title': 'Pentacel®-Primed', 'description': 'Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.'}], 'classes': [{'title': 'Anti-Pertussis (EU/mL) Pre-Dose', 'categories': [{'measurements': [{'value': '7.67', 'groupId': 'OG000', 'lowerLimit': '6.66', 'upperLimit': '8.84'}, {'value': '9.80', 'groupId': 'OG001', 'lowerLimit': '7.81', 'upperLimit': '12.29'}]}]}, {'title': 'Anti-Pertussis (EU/mL) Post-Dose', 'categories': [{'measurements': [{'value': '154.32', 'groupId': 'OG000', 'lowerLimit': '139.58', 'upperLimit': '170.62'}, {'value': '180.77', 'groupId': 'OG001', 'lowerLimit': '150.33', 'upperLimit': '217.38'}]}]}, {'title': 'Anti-Filamentous Haemagglutinin (EU/mL) Pre-Dose', 'categories': [{'measurements': [{'value': '5.03', 'groupId': 'OG000', 'lowerLimit': '4.25', 'upperLimit': '5.96'}, {'value': '7.52', 'groupId': 'OG001', 'lowerLimit': '5.45', 'upperLimit': '10.39'}]}]}, {'title': 'Anti-Filamentous Haemagglutinin (EU/mL) Post-Dose', 'categories': [{'measurements': [{'value': '82.11', 'groupId': 'OG000', 'lowerLimit': '73.39', 'upperLimit': '91.88'}, {'value': '120.03', 'groupId': 'OG001', 'lowerLimit': '98.10', 'upperLimit': '146.86'}]}]}, {'title': 'Anti-Fimbriae Types 2 and 3 (EU/mL) Pre-dose', 'categories': [{'measurements': [{'value': '24.45', 'groupId': 'OG000', 'lowerLimit': '21.22', 'upperLimit': '28.16'}, {'value': '34.50', 'groupId': 'OG001', 'lowerLimit': '27.00', 'upperLimit': '44.09'}]}]}, {'title': 'Anti-Fimbriae Types 2 and 3 (EU/mL) Post-dose', 'categories': [{'measurements': [{'value': '450.56', 'groupId': 'OG000', 'lowerLimit': '407.40', 'upperLimit': '498.30'}, {'value': '649.86', 'groupId': 'OG001', 'lowerLimit': '551.73', 'upperLimit': '765.45'}]}]}, {'title': 'Anti-Pertactin (EU/mL) Pre-dose', 'categories': [{'measurements': [{'value': '15.62', 'groupId': 'OG000', 'lowerLimit': '13.72', 'upperLimit': '17.78'}, {'value': '9.16', 'groupId': 'OG001', 'lowerLimit': '7.10', 'upperLimit': '11.81'}]}]}, {'title': 'Anti-Pertactin (EU/mL) Post-dose', 'categories': [{'measurements': [{'value': '229.59', 'groupId': 'OG000', 'lowerLimit': '207.45', 'upperLimit': '254.08'}, {'value': '148.80', 'groupId': 'OG001', 'lowerLimit': '120.63', 'upperLimit': '183.55'}]}]}, {'title': 'Anti-Diphtheria (IU/mL) Pre-dose', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.12'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.14'}]}]}, {'title': 'Anti-Diphtheria (IU/mL) Post-dose', 'categories': [{'measurements': [{'value': '19.59', 'groupId': 'OG000', 'lowerLimit': '17.06', 'upperLimit': '22.51'}, {'value': '22.56', 'groupId': 'OG001', 'lowerLimit': '17.78', 'upperLimit': '28.62'}]}]}, {'title': 'Anti-Tetanus (IU/mL) Pre-dose', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '0.43'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '0.34'}]}]}, {'title': 'Anti-Tetanus (IU/mL) Post-dose', 'categories': [{'measurements': [{'value': '6.21', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '6.89'}, {'value': '4.47', 'groupId': 'OG001', 'lowerLimit': '3.75', 'upperLimit': '5.34'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 and between Days 28-48 post-dose 5', 'unitOfMeasure': 'All units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'GMTs were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DAPTACEL®-Primed', 'description': 'Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.'}, {'id': 'FG001', 'title': 'Pentacel®-Primed', 'description': 'Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '487'}, {'groupId': 'FG001', 'numSubjects': '162'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '477'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 30 March 2005 to 02 March 2006 at 22 US sites.', 'preAssignmentDetails': 'A total of 649 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '649', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DAPTACEL®-Primed', 'description': 'Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.'}, {'id': 'BG001', 'title': 'Pentacel®-Primed', 'description': 'Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '487', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '649', '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': '4.1', 'spread': '0.14', 'groupId': 'BG000'}, {'value': '4.1', 'spread': '0.16', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '0.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '487', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '649', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 649}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2005-11-24', 'resultsFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2005-11-24', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-18', 'studyFirstPostDateStruct': {'date': '2005-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination', 'timeFrame': '0 to 7 days Post-Dose 5'}, {'measure': 'Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination', 'timeFrame': 'Day 28 to 48 Post-dose 5', 'description': 'Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.'}, {'measure': 'Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination', 'timeFrame': 'Day 28 to 48 Post-Dose 5', 'description': 'Booster response calculation: If pre-Dose 5 titer \\< 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.'}, {'measure': 'Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.', 'timeFrame': 'Day 0 and between Days 28-48 Post-dose 5'}, {'measure': 'Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination', 'timeFrame': 'Day 0 and between Days 28-48 post-dose 5'}]}, 'conditionsModule': {'keywords': ['DAPTACEL®', 'Pentacel™', 'Diphtheria', 'Tetanus', 'Pertussis', 'Whooping cough', 'Acellular Pertussis Vaccine Adsorbed'], 'conditions': ['Diphtheria', 'Tetanus', 'Pertussis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\n1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.\n2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.\n\nObservational Objectives:\n\n1. To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.\n2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.\n3. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 4 and \\< 7 years from date of birth at the time of study vaccination\n* Signed and dated Investigational Review Board (IRB)-approved informed consent from a parent or legally authorized representative. Signed and dated IRB-approved assent from subject if required by IRB\n* Judged to be in good health on the basis of reported medical history and physical examination\n* Able and willing to attend the scheduled visits and to comply with the study procedures\n* Has documented complete infant series and the 4th dose of DAPTACEL® or Pentacel™ in Study P3T06 (i.e., 4 previous administrations of DAPTACEL® or Pentacel™).\n\nExclusion Criteria:\n\n* Received a 5th dose of DTaP-containing vaccine\n* a. For subjects in the DAPTACEL® arm: Received a 4th dose of Inactivated Poliovirus Vaccine (IPV) vaccine and/or a 2nd dose of Measles, Mumps, and Rubella (MMR) vaccine scheduled at 4 to 6 years of age.\n\n b. For subjects in the Pentacel™ arm: Received a 2nd dose of MMR vaccine scheduled at 4 to 6 years of age\n* Severe hypersensitivity to any component of the vaccine such as an anaphylactic reaction observed following a previous vaccination\n* Serious underlying chronic disease, including, but not limited to:·Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder·Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. These may include progressive neurologic disorders (e.g., infantile spasms, uncontrolled progressive encephalopathy) and encephalopathy within 7 days following previous vaccination\n* Known or suspected primary or acquired disease of the immune system\n* Administration of immune globulin, other blood products within the last 3 months, injected or oral corticosteroids or other immunomodulator therapy within 6 weeks prior to study vaccination. Individuals on a tapering dose schedule of oral steroids lasting \\< 7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment\n* Had allergy shots started or had changes in regimen or dosing of allergy shots within 4 weeks prior to study vaccination\n* Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (if applicable)\n* Any other condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine\n* Enrolled in another vaccine trial\n* Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months\n* Known or suspected allergy to any of the vaccines or vaccine components intended for use in this study.'}, 'identificationModule': {'nctId': 'NCT00258895', 'briefTitle': 'Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With DAPTACEL® or Pentacel®', 'orgStudyIdInfo': {'id': 'P3T11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DAPTACEL Primed', 'description': 'Participants received Daptacel in Study P3T06.', 'interventionNames': ['Biological: DAPTACEL®: DTaP']}, {'type': 'EXPERIMENTAL', 'label': 'Pentacel Primed', 'description': 'Participants received Pentacel in Study P3T06', 'interventionNames': ['Biological: DAPTACEL®: DTaP']}], 'interventions': [{'name': 'DAPTACEL®: DTaP', 'type': 'BIOLOGICAL', 'otherNames': ['DAPTACEL®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['DAPTACEL Primed']}, {'name': 'DAPTACEL®: DTaP', 'type': 'BIOLOGICAL', 'otherNames': ['DAPTACEL®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Pentacel Primed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'city': 'Bossier City', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.51599, 'lon': -93.73212}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Pembroke', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.68016, 'lon': -79.19504}}, {'city': 'Sylva', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.37371, 'lon': -83.22598}}, {'city': 'Norristown', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.1215, 'lon': -75.3399}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}, {'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}