Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-30 @ 8:54 PM
Study NCT ID:
NCT01311557
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2011-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Adacel® Vaccine Administered to Persons 10 Years of Age
Sponsor:
Organization:
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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509326', 'term': 'adacel'}]}}, '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 up to Day 30 post-vaccination', 'description': 'Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants 10 to <11 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.', 'otherNumAtRisk': 651, 'otherNumAffected': 521, 'seriousNumAtRisk': 651, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Participants 11 to <12 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.', 'otherNumAtRisk': 651, 'otherNumAffected': 522, 'seriousNumAtRisk': 651, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection-site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 651, 'numEvents': 521, 'numAffected': 521}, {'groupId': 'EG001', 'numAtRisk': 651, 'numEvents': 522, 'numAffected': 522}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection-site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 651, 'numEvents': 254, 'numAffected': 254}, {'groupId': 'EG001', 'numAtRisk': 651, 'numEvents': 248, 'numAffected': 248}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection-site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 651, 'numEvents': 227, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 651, 'numEvents': 216, 'numAffected': 216}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 651, 'numEvents': 213, 'numAffected': 213}, {'groupId': 'EG001', 'numAtRisk': 651, 'numEvents': 243, 'numAffected': 243}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 651, 'numEvents': 169, 'numAffected': 169}, {'groupId': 'EG001', 'numAtRisk': 651, 'numEvents': 189, 'numAffected': 189}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 651, 'numEvents': 316, 'numAffected': 316}, {'groupId': 'EG001', 'numAtRisk': 651, 'numEvents': 364, 'numAffected': 364}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 651, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '613', 'groupId': 'OG000'}, {'value': '608', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants 10 to <11 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}, {'id': 'OG001', 'title': 'Participants 11 to <12 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}], 'classes': [{'title': 'Anti-Pertussis toxoid (N=577, 566)', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '32.4'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '29.6', 'upperLimit': '34.7'}]}]}, {'title': 'Anti-Filamentous hemagglutinin, Day 30(N=613, 608)', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000', 'lowerLimit': '218', 'upperLimit': '247'}, {'value': '225', 'groupId': 'OG001', 'lowerLimit': '211', 'upperLimit': '239'}]}]}, {'title': 'Anti-Pertactin (N=613, 607)', 'categories': [{'measurements': [{'value': '464', 'groupId': 'OG000', 'lowerLimit': '426', 'upperLimit': '506'}, {'value': '444', 'groupId': 'OG001', 'lowerLimit': '408', 'upperLimit': '482'}]}]}, {'title': 'Anti-Fimbriae types 2 & 3 (N=606, 605)', 'categories': [{'measurements': [{'value': '477', 'groupId': 'OG000', 'lowerLimit': '413', 'upperLimit': '550'}, {'value': '540', 'groupId': 'OG001', 'lowerLimit': '478', 'upperLimit': '611'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.940', 'ciLowerLimit': '0.843', 'ciUpperLimit': '1.05', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Pertussis toxoid (PT) GMT Group 1 / GMT Group 2.\n\nThe GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \\> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.944', 'ciUpperLimit': '1.13', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A two-sided 95% CI was constructed around each of the ratios: anti-Filamentous hemagglutinin (FHA) GMT Group 1 / GMT Group 2.\n\nThe GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \\> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.928', 'ciUpperLimit': '1.18', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A two-sided 95% CI was constructed around each of the ratios: Anti-Pertactin (PRN) GMT Group 1 / GMT Group 2.\n\nThe GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \\> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.882', 'ciLowerLimit': '0.731', 'ciUpperLimit': '1.06', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A two-sided 95% CI was constructed around each of the ratios: anti-Fimbriae types 2 and 3 (FIM) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \\> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 post-vaccination', 'description': 'Anti-Pertussis titers (Pertussis toxoid \\[PT\\], Filamentous hemagglutinin \\[FHA\\], Pertactin \\[PRN\\], Fimbriae types 2 and 3 \\[FIM\\]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Titers (1/dilutions)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers were assessed in the Per-protocol Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '613', 'groupId': 'OG000'}, {'value': '608', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants 10 to <11 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}, {'id': 'OG001', 'title': 'Participants 11 to <12 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}], 'classes': [{'title': 'Anti-Pertussis toxoid (N=554, 549)', 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000'}, {'value': '56.1', 'groupId': 'OG001'}]}]}, {'title': 'Anti-filamentous hemagglutinin (N=609, 605)', 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000'}, {'value': '84.8', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Pertactin (N=600, 600)', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000'}, {'value': '97.5', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Fimbriae types 2 and 3 (N=583, 585)', 'categories': [{'measurements': [{'value': '93.7', 'groupId': 'OG000'}, {'value': '97.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post-vaccination', 'description': 'Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid \\[PT\\], filamentous hemagglutinin \\[FHA\\], pertactin \\[PRN\\], fimbriae types 2 and 3 \\[FIM\\]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were \\> 93 EU/mL for PT, \\> 170 EU/mL for FHA, \\> 115 EU mL for PRN, or \\> 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Anti-pertussis booster response were assessed in the Per-protocol Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '613', 'groupId': 'OG000'}, {'value': '608', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants 10 to <11 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}, {'id': 'OG001', 'title': 'Participants 11 to <12 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}], 'classes': [{'title': 'Anti-Tetanus (N=610, 603)', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}, {'value': '98.8', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria (N=609, 605)', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}, {'value': '98.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post-vaccination', 'description': 'Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were \\> 2.56 EU/mL for diphtheria or \\> 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Anti-Tetanus and anti-Diphtheria booster responses were assessed in the Per-protocol Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '613', 'groupId': 'OG000'}, {'value': '608', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants 10 to <11 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}, {'id': 'OG001', 'title': 'Participants 11 to <12 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}], 'classes': [{'title': 'Anti-Tetanus (Pre-vaccination, N=610, 604)', 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000'}, {'value': '91.2', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus (Post-vaccination, N=613, 607)', 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria (Pre-vaccination, N=610, 605)', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000'}, {'value': '75.9', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria (Post-vaccination, N=612, 608)', 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and 30 days post-vaccination', 'description': 'Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroprotection rates were assessed in the Per Protocol Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '613', 'groupId': 'OG000'}, {'value': '608', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants 10 to <11 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}, {'id': 'OG001', 'title': 'Participants 11 to <12 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}], 'classes': [{'title': 'Anti-Pertussis toxoid; Day 0 (N = 590, 591)', 'categories': [{'measurements': [{'value': '4.96', 'groupId': 'OG000', 'lowerLimit': '4.54', 'upperLimit': '5.42'}, {'value': '4.85', 'groupId': 'OG001', 'lowerLimit': '4.41', 'upperLimit': '5.34'}]}]}, {'title': 'Anti-Pertussis toxoid; Day 30 (N = 577, 566)', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '32.4'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '29.6', 'upperLimit': '34.7'}]}]}, {'title': 'Anti-Filamentous hemagglutinin Day 0 (N=609, 605)', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '24.2'}, {'value': '20.3', 'groupId': 'OG001', 'lowerLimit': '18.5', 'upperLimit': '22.3'}]}]}, {'title': 'Anti-Filamentous hemagglutinin Day 30 (N=613, 608)', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000', 'lowerLimit': '218', 'upperLimit': '247'}, {'value': '225', 'groupId': 'OG001', 'lowerLimit': '211', 'upperLimit': '239'}]}]}, {'title': 'Anti-Pertactin; Day 0 (N = 600, 601)', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '17.1'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '13.5', 'upperLimit': '16.2'}]}]}, {'title': 'Anti-Pertactin; Day 30 (N = 613, 607)', 'categories': [{'measurements': [{'value': '464', 'groupId': 'OG000', 'lowerLimit': '426', 'upperLimit': '506'}, {'value': '444', 'groupId': 'OG001', 'lowerLimit': '408', 'upperLimit': '482'}]}]}, {'title': 'Anti-Fimbriae types 2 and 3; Day 0 (N = 590, 587)', 'categories': [{'measurements': [{'value': '6.77', 'groupId': 'OG000', 'lowerLimit': '6.05', 'upperLimit': '7.57'}, {'value': '7.07', 'groupId': 'OG001', 'lowerLimit': '6.33', 'upperLimit': '7.89'}]}]}, {'title': 'Anti-Fimbriae types 2 and 3; Day 30 (N = 606, 605)', 'categories': [{'measurements': [{'value': '477', 'groupId': 'OG000', 'lowerLimit': '413', 'upperLimit': '550'}, {'value': '540', 'groupId': 'OG001', 'lowerLimit': '478', 'upperLimit': '611'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 post-vaccination', 'description': 'Anti-Pertussis titers (Pertussis toxoid \\[PT\\], Filamentous hemagglutinin \\[FHA\\], Pertactin \\[PRN\\], Fimbriae types 2 and 3 \\[FIM\\]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Titers (1/dilutions)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers were assessed in the Per Protocol Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '650', 'groupId': 'OG000'}, {'value': '649', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants 10 to <11 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}, {'id': 'OG001', 'title': 'Participants 11 to <12 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}], 'classes': [{'title': 'Injection-site Pain (N=644, 645)', 'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000'}, {'value': '80.9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Pain (N=644, 645)', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Erythema (N=644, 645)', 'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000'}, {'value': '38.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Erythema (N=644, 645)', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Swelling (N=644, 645)', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}, {'value': '33.5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Swelling (N=644, 645)', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Fever (N=642, 644)', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (N=642, 644)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Headache (N=644, 646)', 'categories': [{'measurements': [{'value': '33.1', 'groupId': 'OG000'}, {'value': '37.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (N=644, 646)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Malaise (N=644, 646)', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '29.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (N=644, 646)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia (N=644, 645)', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000'}, {'value': '56.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (N=644, 645)', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 7 post-vaccination', 'description': 'Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants 10 to <11 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}, {'id': 'FG001', 'title': 'Participants 11 to <12 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '651'}, {'groupId': 'FG001', 'numSubjects': '651'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '646'}, {'groupId': 'FG001', 'numSubjects': '645'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Study participants were enrolled from 07 March 2011 to 19 May 2011 at 36 clinical centers in the United States.', 'preAssignmentDetails': 'A total of 1302 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'BG000'}, {'value': '651', 'groupId': 'BG001'}, {'value': '1302', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants 10 to <11 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}, {'id': 'BG001', 'title': 'Participants 11 to <12 Years of Age', 'description': 'Participants received 1 dose of Adacel® vaccine at Visit 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '651', 'groupId': 'BG000'}, {'value': '651', 'groupId': 'BG001'}, {'value': '1302', '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': '10.5', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '11.4', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '10.5', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '620', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '346', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '682', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '651', 'groupId': 'BG000'}, {'value': '651', 'groupId': 'BG001'}, {'value': '1302', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2012-04-27', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-01', 'studyFirstSubmitDate': '2011-03-07', 'dispFirstSubmitQcDate': '2012-04-27', 'resultsFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2011-03-07', 'dispFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-01', 'studyFirstPostDateStruct': {'date': '2011-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine', 'timeFrame': 'Day 30 post-vaccination', 'description': 'Anti-Pertussis titers (Pertussis toxoid \\[PT\\], Filamentous hemagglutinin \\[FHA\\], Pertactin \\[PRN\\], Fimbriae types 2 and 3 \\[FIM\\]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine', 'timeFrame': '30 days post-vaccination', 'description': 'Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid \\[PT\\], filamentous hemagglutinin \\[FHA\\], pertactin \\[PRN\\], fimbriae types 2 and 3 \\[FIM\\]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were \\> 93 EU/mL for PT, \\> 170 EU/mL for FHA, \\> 115 EU mL for PRN, or \\> 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.'}, {'measure': 'Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine', 'timeFrame': '30 days post-vaccination', 'description': 'Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were \\> 2.56 EU/mL for diphtheria or \\> 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and 30 days post-vaccination', 'description': 'Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.'}, {'measure': 'Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 post-vaccination', 'description': 'Anti-Pertussis titers (Pertussis toxoid \\[PT\\], Filamentous hemagglutinin \\[FHA\\], Pertactin \\[PRN\\], Fimbriae types 2 and 3 \\[FIM\\]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).'}, {'measure': 'Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine', 'timeFrame': 'Day 0 up to Day 7 post-vaccination', 'description': 'Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tetanus', 'Diphtheria', 'Pertussis', 'Tdap vaccine', 'Adacel®'], 'conditions': ['Tetanus', 'Diphtheria', 'Pertussis']}, 'referencesModule': {'references': [{'pmid': '25230939', 'type': 'DERIVED', 'citation': 'Marshall GS, Pool V, Greenberg DP, Johnson DR, Sheng X, Decker MD. Safety and immunogenicity of tetanus-diphtheria-acellular pertussis vaccine administered to children 10 or 11 years of age. Clin Vaccine Immunol. 2014 Nov;21(11):1560-4. doi: 10.1128/CVI.00474-14. Epub 2014 Sep 17.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age.\n\nPrimary Objectives:\n\n* To compare pertussis antibody responses induced by Adacel® in persons 10 to \\<11 years of age to those induced by Adacel in persons 11 to \\<12 years of age.\n* To compare the booster responses against pertussis antigens induced by Adacel in persons 10 to \\<11 years of age to those induced by Adacel in persons 11 to \\<12 years of age.\n* To compare booster responses against tetanus and diphtheria induced by Adacel in persons 10 to \\<11 years of age to those induced by Adacel in persons 11 to \\<12 years of age.\n\nSecondary Objective:\n\n* To compare seroprotection rates against tetanus and diphtheria induced by Adacel in persons 10 to \\<11 years of age to those induced by Adacel in persons 11 to \\<12 years of age.', 'detailedDescription': 'Study participants will receive a single dose of study vaccine and will then be monitored for safety from the day of vaccination for up to 30 days post-vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age is \\> 10 to \\< 12 years of age at the time of vaccination.\n* Assent form has been signed and dated by the subject, and informed consent has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).\n* Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.\n* For a female of childbearing potential, abstinence or use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.\n* Documented vaccination history of receiving 5 previous doses of DTaP (combination diphtheria, tetanus, and acellular pertussis) vaccine (consisting of 3 infant doses in the first year of life, a 4th dose in the 2nd year of life, and a 5th dose at 4 through 6 years of age).\n\nExclusion Criteria:\n\n* Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.\n* Serious, acute, or chronic disease that is unstable or that, in the opinion of the Investigator, might: (i) interfere with the ability to participate fully in the study; or (ii) interfere with evaluation of the vaccine.\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* Prior receipt of pertussis, diphtheria, or tetanus containing vaccines within the past 5 years.\n* A personal history of physician-diagnosed or laboratory confirmed pertussis disease within the last 2 years.\n* A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine.\n* Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of the immune response.\n* History of allergy to egg proteins, latex, or any constituents of the vaccine.\n* Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.\n* Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the 2nd visit; except that influenza vaccine may have been received between 30 and 15 days (but no less than 15 days) before receiving study vaccine.\n* Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study.\n* Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the parent/guardian.\n* Laboratory-confirmed thrombocytopenia, bleeding disorders, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination, at the discretion of the Investigator.\n* Known pregnancy, or a positive urine or serum pregnancy test.\n* Prior personal history of Guillain-Barré syndrome.\n* Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study.'}, 'identificationModule': {'nctId': 'NCT01311557', 'briefTitle': 'Study of Adacel® Vaccine Administered to Persons 10 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of Adacel® Vaccine Administered to Persons 10 Years of Age', 'orgStudyIdInfo': {'id': 'Td519'}, 'secondaryIdInfos': [{'id': 'U1111-1115-6619', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adacel Vaccine Group 1', 'description': 'Participants enrolled at 10 to \\< 11 years of age', 'interventionNames': ['Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed']}, {'type': 'EXPERIMENTAL', 'label': 'Adacel Vaccine Group 2', 'description': 'Participants enrolled at 11 to \\< 12 years of age', 'interventionNames': ['Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed']}], 'interventions': [{'name': 'Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed', 'type': 'BIOLOGICAL', 'otherNames': ['Adacel®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Adacel Vaccine Group 1']}, {'name': 'Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed', 'type': 'BIOLOGICAL', 'otherNames': ['Adacel®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Adacel Vaccine Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'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': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80501', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '33141', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'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': '40040', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '41017', 'city': 'Crestview Hills', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 39.02728, 'lon': -84.58494}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '42431', 'city': 'Madisonville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.3281, 'lon': -87.49889}}, {'zip': '71037', 'city': 'Haughton', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.53265, 'lon': -93.50406}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '01801', 'city': 'Woburn', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.47926, 'lon': -71.15228}}, {'zip': '55441', 'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '44121', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29812', 'city': 'Barnwell', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.24487, 'lon': -81.35872}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76135', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78205', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84057', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': '23113', 'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}, {'zip': '22180', 'city': 'Vienna', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.90122, 'lon': -77.26526}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '54449', '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', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}