Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 8:11 PM
Study NCT ID:
NCT00777257
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2008-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D004165', 'term': 'Diphtheria'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509326', 'term': 'adacel'}, {'id': 'D022401', 'term': 'Meningococcal Vaccines'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, '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 over 2 months post-dose 1 vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Tdap + Placebo Vaccines Day 0', 'description': 'Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later', 'otherNumAtRisk': 444, 'otherNumAffected': 0, 'seriousNumAtRisk': 444, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Tdap + Menactra® Vaccines Day 0', 'description': 'Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later', 'otherNumAtRisk': 450, 'otherNumAffected': 0, 'seriousNumAtRisk': 450, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Menactra® + Placebo Vaccines Day 0', 'description': 'Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.', 'otherNumAtRisk': 451, 'otherNumAffected': 0, 'seriousNumAtRisk': 451, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 450, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 444, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 450, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tdap + Placebo Vaccines Day 0', 'description': 'Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later'}, {'id': 'OG001', 'title': 'Tdap + Menactra® Vaccines Day 0', 'description': 'Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later'}, {'id': 'OG002', 'title': 'Menactra® + Placebo Vaccines Day 0', 'description': 'Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.'}], 'classes': [{'title': 'Meningococcal Serogroup A', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}]}, {'title': 'Meningococcal Serogroup C', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}, {'title': 'Meningococcal Serogroup Y', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}, {'title': 'Meningococcal Serogroup W-135', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 28 post-vaccination', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Serum bactericidal activity using baby rabbit complement (SBA-BR) titers for each meningococcal serogroup was evaluated in the per-protocol population'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}, {'value': '383', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tdap + Placebo Vaccines Day 0', 'description': 'Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later'}, {'id': 'OG001', 'title': 'Tdap + Menactra® Vaccines Day 0', 'description': 'Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later'}, {'id': 'OG002', 'title': 'Menactra® + Placebo Vaccines Day 0', 'description': 'Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.'}], 'classes': [{'title': 'Diphtheria toxoid - Day 0', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.3'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.3'}, {'value': '56.2', 'groupId': 'OG002', 'lowerLimit': '48.9', 'upperLimit': '64.6'}]}]}, {'title': 'Diphtheria toxoid - Day 28', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '8.8'}, {'value': '49.8', 'groupId': 'OG001', 'lowerLimit': '43.8', 'upperLimit': '56.7'}, {'value': '38.2', 'groupId': 'OG002', 'lowerLimit': '33.3', 'upperLimit': '43.9'}]}]}, {'title': 'Tetanus toxoid - Day 0', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '0.9'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '0.9'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.1'}]}]}, {'title': 'Tetanus toxoid - Day 28', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '24.7'}, {'value': '16.4', 'groupId': 'OG001', 'lowerLimit': '15.2', 'upperLimit': '17.5'}, {'value': '21.1', 'groupId': 'OG002', 'lowerLimit': '19.6', 'upperLimit': '22.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 and Day 28 post-vaccination', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}, {'value': '451', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tdap + Placebo Vaccines Day 0', 'description': 'Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later'}, {'id': 'OG001', 'title': 'Tdap + Menactra® Vaccines Day 0', 'description': 'Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later'}, {'id': 'OG002', 'title': 'Menactra® + Placebo Vaccines Day 0', 'description': 'Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.'}], 'classes': [{'title': 'Any Solicited Injection Site Reaction-Tdap, Dose 1', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Solicited Inj. Site Reaction-Tdap, Dose 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Erythyma (Dose 1)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Erythema (≥ 2 inches, Dose 1)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any swelling (Dose 1)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 swelling (≥ 2 inches, Dose 1)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain (Dose 1)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain (Incapacitating, Dose 1)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Solicited Inj. Site Reaction-Menactra, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'Grd 3 Solicited Inj Site Reaction-Menactra, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Any Erythyma (Dose 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Erythema (≥ 2 inches, Dose 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any swelling (Dose 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 swelling (≥ 2 inches, Dose 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain (Dose 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain (Incapacitating, Dose 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any Solicited Inj. Site Reaction-Placebo, Dose 1', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Grd 3 Solicited Inj. Site Reaction-Placebo, Dose 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any Erythyma (Dose 1)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Erythema (≥ 2 inches, Dose 1)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any swelling (Dose 1)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 swelling (≥ 2 inches, Dose 1)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain (Dose 1)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain (Incapacitating, Dose 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any Solicited Injection Site Reaction (Dose 2)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Solicited Inj. Site Reaction (Dose 2)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Any Erythyma (Dose 2)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Erythema (≥ 2 inches, Dose 2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any swelling (Dose 2)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 swelling (≥ 2 inches, Dose 2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain (Dose 2)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain (Incapacitating, Dose 2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Any Solicited Systemic Reaction (Dose 1)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Solicited Systemic Reaction (Dose 1)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever (Dose 1)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fever (≥ 40.0 °C, Dose 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Headache (Dose 1)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Grd 3 Headache (prevents daily activities, Dose 1)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any Malaise (Dose 1)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Grd 3 Malaise (prevents daily activities, Dose 1)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any Myalgia (Dose 1)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Grd 3 Myalgia (prevents daily activities, Dose 1)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any Solicited Systemic Reaction (Dose 2)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Solicited Systemic Reaction (Dose 2)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever (Dose 2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fever (≥ 40.0 °C, Dose 2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Headache (Dose 2)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Grd 3 Headache (prevents daily activities, Dose 2)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Any Malaise (Dose 2)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Grd 3 Malaise (prevents daily activities, Dose 2)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Any Myalgia (Dose 2)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Grd 3 Myalgia (prevents daily activities, Dose 2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 7 days post-vaccination', 'description': 'Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated participants intend-to-treat population'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}, {'value': '383', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tdap + Placebo Vaccines Day 0', 'description': 'Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later'}, {'id': 'OG001', 'title': 'Tdap + Menactra® Vaccines Day 0', 'description': 'Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later'}, {'id': 'OG002', 'title': 'Menactra® + Placebo Vaccines Day 0', 'description': 'Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.'}], 'classes': [{'title': 'Pertussis Toxoid - Day 0', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '13.3', 'upperLimit': '17.5'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '16.0'}, {'value': '20.7', 'groupId': 'OG002', 'lowerLimit': '18.0', 'upperLimit': '23.9'}]}]}, {'title': 'Pertussis Toxoid - Day 28', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '79.8', 'upperLimit': '97.1'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '67.0', 'upperLimit': '80.3'}, {'value': '107.4', 'groupId': 'OG002', 'lowerLimit': '97.6', 'upperLimit': '118.2'}]}]}, {'title': 'Filamentous Haemagglutinin - Day 0', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '24.3'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '22.3'}, {'value': '28.5', 'groupId': 'OG002', 'lowerLimit': '25.4', 'upperLimit': '31.9'}]}]}, {'title': 'Filamentous Haemagglutinin - Day 28', 'categories': [{'measurements': [{'value': '179.5', 'groupId': 'OG000', 'lowerLimit': '163.2', 'upperLimit': '197.6'}, {'value': '140.2', 'groupId': 'OG001', 'lowerLimit': '128.0', 'upperLimit': '153.6'}, {'value': '245.1', 'groupId': 'OG002', 'lowerLimit': '226.4', 'upperLimit': '265.2'}]}]}, {'title': 'Pertactin - Day 0', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '10.3'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '9.5'}, {'value': '11.9', 'groupId': 'OG002', 'lowerLimit': '10.4', 'upperLimit': '13.6'}]}]}, {'title': 'Pertactin - Day 28', 'categories': [{'measurements': [{'value': '176.5', 'groupId': 'OG000', 'lowerLimit': '156.6', 'upperLimit': '199.0'}, {'value': '130.3', 'groupId': 'OG001', 'lowerLimit': '116.5', 'upperLimit': '145.9'}, {'value': '213.6', 'groupId': 'OG002', 'lowerLimit': '192.8', 'upperLimit': '236.6'}]}]}, {'title': 'Fimbriae Types 2 and 3 - Day 0', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '15.9'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '14.6'}, {'value': '14.2', 'groupId': 'OG002', 'lowerLimit': '12.2', 'upperLimit': '16.6'}]}]}, {'title': 'Fimbriae Types 2 and 3 - Day 28', 'categories': [{'measurements': [{'value': '1133.4', 'groupId': 'OG000', 'lowerLimit': '979.3', 'upperLimit': '1311.7'}, {'value': '699.1', 'groupId': 'OG001', 'lowerLimit': '602.9', 'upperLimit': '810.7'}, {'value': '832.3', 'groupId': 'OG002', 'lowerLimit': '712.0', 'upperLimit': '972.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 and Day 28 Post-vaccination', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tdap + Placebo Vaccines Day 0', 'description': 'Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later'}, {'id': 'FG001', 'title': 'Tdap + Menactra® Vaccines Day 0', 'description': 'Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later'}, {'id': 'FG002', 'title': 'Menactra® + Placebo Vaccines Day 0', 'description': 'Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '444'}, {'groupId': 'FG001', 'numSubjects': '450'}, {'groupId': 'FG002', 'numSubjects': '451'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '433'}, {'groupId': 'FG001', 'numSubjects': '438'}, {'groupId': 'FG002', 'numSubjects': '442'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Study participants were enrolled from 26 April 2005 through 24 June 2005 in 21 Medical centers in the US', 'preAssignmentDetails': 'A total of 1345 participants that met the inclusion and exclusion criteria were randomized and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'BG000'}, {'value': '450', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}, {'value': '1345', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tdap + Placebo Vaccines Day 0', 'description': 'Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later'}, {'id': 'BG001', 'title': 'Tdap + Menactra® Vaccines Day 0', 'description': 'Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later'}, {'id': 'BG002', 'title': 'Menactra® + Placebo Vaccines Day 0', 'description': 'Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '444', 'groupId': 'BG000'}, {'value': '450', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}, {'value': '1345.0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0.0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0.0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '1.87', 'groupId': 'BG000'}, {'value': '13.0', 'spread': '1.93', 'groupId': 'BG001'}, {'value': '13.3', 'spread': '2.05', 'groupId': 'BG002'}, {'value': '13.1', 'spread': '1.95', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}, {'value': '599.0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}, {'value': '746.0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '444', 'groupId': 'BG000'}, {'value': '450', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}, {'value': '1345.0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2008-10-21', 'resultsFirstSubmitDate': '2009-09-24', 'studyFirstSubmitQcDate': '2008-10-21', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-01', 'studyFirstPostDateStruct': {'date': '2008-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.', 'timeFrame': 'Day 0 to Day 28 post-vaccination'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.', 'timeFrame': 'Day 0 and Day 28 post-vaccination'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.', 'timeFrame': 'Day 0 and Day 28 Post-vaccination'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.', 'timeFrame': '0 to 7 days post-vaccination', 'description': 'Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Meningitis', 'Meningococcemia', 'Pertussis', 'Neisseria meningitidis', 'Tetanus', 'Diphtheria'], 'conditions': ['Meningitis', 'Meningococcemia', 'Pertussis', 'Tetanus', 'Diphtheria']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.\n\nPrimary Objective:\n\nTo determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately.\n\nSecondary Objective:\n\nTo compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Healthy as determined by medical history and physical examination.\n* Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.\n* Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.\n* Informed assent form that has been approved by the IRB signed by the subject.\n* Subject (female) agrees to use measures to prevent pregnancy during the study.\n\nExclusion Criteria :\n\n* Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).\n* Known or suspected impairment of immunologic function.\n* Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.\n* History of documented invasive meningococcal disease or previous meningococcal vaccination.\n* History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.\n* Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \\<7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.\n* Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.\n* Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.\n* Suspected or known hypersensitivity to either of the two study vaccines or their components.\n* Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.\n* Enrolled in another clinical trial.\n* Diagnosed with any 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* For all females, a positive or equivocal urine pregnancy test at time of study vaccination.\n* Nursing mothers.'}, 'identificationModule': {'nctId': 'NCT00777257', 'briefTitle': 'Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of Meningococcal (Groups A, C, Y, and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Adolescents in the US When Administered Concomitantly With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap Vaccine)', 'orgStudyIdInfo': {'id': 'MTA21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group A', 'description': 'Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later', 'interventionNames': ['Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group B', 'description': 'Tdap vaccine + Menactra® vaccine concomitantly on Day 0; placebo 28 days later', 'interventionNames': ['Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group C', 'description': 'Menactra® vaccine + placebo concomitantly on Day 0; Tdap vaccine 28 days later', 'interventionNames': ['Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap']}], 'interventions': [{'name': 'T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.', 'type': 'BIOLOGICAL', 'otherNames': ['ADACEL®', 'Menactra®', 'Sterile Buffered 0.9% Sodium Chloride'], 'description': 'Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular', 'armGroupLabels': ['Study Group A']}, {'name': 'Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®', 'Adacel®', 'Sterile Buffered 0.9% Sodium Chloride'], 'description': 'Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular', 'armGroupLabels': ['Study Group B']}, {'name': 'Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®', 'Adacel®', 'Sterile Buffered 0.9% Sodium Chloride'], 'description': 'Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular', 'armGroupLabels': ['Study Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '80303', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '30062', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '30189', 'city': 'Woodstock', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.10149, 'lon': -84.51938}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01801', 'city': 'Woburn', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.47926, 'lon': -71.15228}}, {'zip': '87108', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28779', 'city': 'Sylva', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.37371, 'lon': -83.22598}}, {'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '44118', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45404', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '18960', 'city': 'Sellersville', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.35399, 'lon': -75.3049}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}