Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-26 @ 12:13 PM
Study NCT ID:
NCT00712959
Status:
COMPLETED
Last Update Posted:
2014-04-30
First Post:
2008-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D004165', 'term': 'Diphtheria'}], 'ancestors': [{'id': 'D001885', 'term': 'Bordetella 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': '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': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'C509326', 'term': 'adacel'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination', 'description': 'The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)', 'otherNumAtRisk': 361, 'otherNumAffected': 309, 'seriousNumAtRisk': 361, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Group 2: Tdap Vaccine-naïve', 'description': 'Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.', 'otherNumAtRisk': 407, 'otherNumAffected': 341, 'seriousNumAtRisk': 407, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Solicited Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numEvents': 309, 'numAffected': 309}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 341, 'numAffected': 341}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Solicited Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 351, 'numEvents': 81, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 120, 'numAffected': 120}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 350, 'numEvents': 103, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 117, 'numAffected': 117}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Solicited Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 351, 'numEvents': 72, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 94, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 351, 'numEvents': 211, 'numAffected': 211}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 216, 'numAffected': 216}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 350, 'numEvents': 142, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 152, 'numAffected': 152}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Arnold-Chiari Malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Animal Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vaginal Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)'}, {'id': 'OG001', 'title': 'Group 2: Tdap Vaccine-naïve', 'description': 'Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.'}], 'classes': [{'title': 'Anti-tetanus Pre-vaccination', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Anti-tetanus Post-vaccination', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria Pre-vaccination', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria Post-vaccination', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and 30 post-vaccination', 'description': 'Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA).\n\nSeroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.'}, {'type': 'PRIMARY', 'title': 'Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)'}, {'id': 'OG001', 'title': 'Group 2: Tdap Vaccine-naïve', 'description': 'Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.'}], 'classes': [{'title': 'Pertussis Toxoid [n=318, 357]', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '105', 'upperLimit': '129'}, {'value': '89.2', 'groupId': 'OG001', 'lowerLimit': '80.2', 'upperLimit': '99.3'}]}]}, {'title': 'Filamentous Haemagglutinin [n=324, 380]', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000', 'lowerLimit': '199', 'upperLimit': '231'}, {'value': '249', 'groupId': 'OG001', 'lowerLimit': '229', 'upperLimit': '272'}]}]}, {'title': 'Pertactin [n=324, 381]', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000', 'lowerLimit': '243', 'upperLimit': '292'}, {'value': '216', 'groupId': 'OG001', 'lowerLimit': '188', 'upperLimit': '247'}]}]}, {'title': 'Fimbriae Types 2 and 3 [n=324, 378]', 'categories': [{'measurements': [{'value': '779', 'groupId': 'OG000', 'lowerLimit': '720', 'upperLimit': '843'}, {'value': '1015', 'groupId': 'OG001', 'lowerLimit': '894', 'upperLimit': '1154'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 post-vaccination', 'description': 'Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean concentrations were assessed in the per-protocol population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)'}, {'id': 'OG001', 'title': 'Group 2: Tdap Vaccine-naïve', 'description': 'Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.'}], 'classes': [{'title': 'Anti-Tetanus [N = 324, 379]', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria [N = 324, 381]', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 post-vaccination', 'description': 'Anti-diphtheria or anti-tetanus booster responses were defined as:\n\nPre-vaccination antibody concentrations of \\< 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to \\< 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster Response to Tetanus and Diptheria antigens were assessed in the per-protocol population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)'}, {'id': 'OG001', 'title': 'Group 2: Tdap Vaccine-naïve', 'description': 'Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.'}], 'classes': [{'title': 'Anti-Pertussis Toxoid [N = 285, 330]', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'Filamentous Haemagglutinin [N = 324, 379]', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Pertactin [N = 324, 381]', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Fimbriae Types 2 and 3 [N = 324, 371]', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 post-vaccination', 'description': 'Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:\n\n* ≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was \\< LLOQ; or\n* ≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but \\< 4 x LLOQ; or\n* ≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ.', 'unitOfMeasure': 'Percentage of Particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster response for each anti-Pertussis antibody was assessed in the per-protocol population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)'}, {'id': 'OG001', 'title': 'Group 2: Tdap Vaccine-naïve', 'description': 'Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.'}], 'classes': [{'title': 'Pertussis Toxoid [Pre, N = 291, 353]', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '17.6'}, {'value': '9.42', 'groupId': 'OG001', 'lowerLimit': '8.20', 'upperLimit': '10.8'}]}]}, {'title': 'Pertussis Toxoid [Post, N = 318, 357]', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '105', 'upperLimit': '129'}, {'value': '89.2', 'groupId': 'OG001', 'lowerLimit': '80.2', 'upperLimit': '99.3'}]}]}, {'title': 'Filamentous Haemagglutinin [Pre, N = 324, 380]', 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000', 'lowerLimit': '31.2', 'upperLimit': '38.7'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '17.7', 'upperLimit': '22.5'}]}]}, {'title': 'Filamentous Haemagglutinin [Post, N = 324, 380]', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000', 'lowerLimit': '199', 'upperLimit': '231'}, {'value': '249', 'groupId': 'OG001', 'lowerLimit': '229', 'upperLimit': '272'}]}]}, {'title': 'Pertactin [Pre, N = 324, 381]', 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '32.7'}, {'value': '8.54', 'groupId': 'OG001', 'lowerLimit': '7.41', 'upperLimit': '9.85'}]}]}, {'title': 'Pertactin [Post, N = 324, 381]', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000', 'lowerLimit': '243', 'upperLimit': '292'}, {'value': '216', 'groupId': 'OG001', 'lowerLimit': '188', 'upperLimit': '247'}]}]}, {'title': 'Fimbriae Types 2 and 3 [Pre, N = 324, 374]', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '139'}, {'value': '37.8', 'groupId': 'OG001', 'lowerLimit': '32.7', 'upperLimit': '43.7'}]}]}, {'title': 'Fimbriae Types 2 and 3 [Post, N=324, 378]', 'categories': [{'measurements': [{'value': '779', 'groupId': 'OG000', 'lowerLimit': '720', 'upperLimit': '843'}, {'value': '1015', 'groupId': 'OG001', 'lowerLimit': '894', 'upperLimit': '1154'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 post-vaccination', 'description': 'Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean concentrations were assessed in the per-protocol population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)'}, {'id': 'OG001', 'title': 'Group 2: Tdap Vaccine-naïve', 'description': 'Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.'}], 'classes': [{'title': 'Anti-Tetanus [Pre, N = 324, 379]', 'categories': [{'measurements': [{'value': '0.835', 'groupId': 'OG000', 'lowerLimit': '0.754', 'upperLimit': '0.924'}, {'value': '0.778', 'groupId': 'OG001', 'lowerLimit': '0.679', 'upperLimit': '0.892'}]}]}, {'title': 'Anti-Tetanus [Post, N = 324, 381]', 'categories': [{'measurements': [{'value': '8.79', 'groupId': 'OG000', 'lowerLimit': '8.06', 'upperLimit': '9.59'}, {'value': '9.64', 'groupId': 'OG001', 'lowerLimit': '8.73', 'upperLimit': '10.7'}]}]}, {'title': 'Anti-Diphtheria [Pre, N = 324, 381]', 'categories': [{'measurements': [{'value': '0.283', 'groupId': 'OG000', 'lowerLimit': '0.235', 'upperLimit': '0.341'}, {'value': '0.198', 'groupId': 'OG001', 'lowerLimit': '0.163', 'upperLimit': '0.240'}]}]}, {'title': 'Anti-Diphtheria [Post, N = 324, 381]', 'categories': [{'measurements': [{'value': '4.06', 'groupId': 'OG000', 'lowerLimit': '3.49', 'upperLimit': '4.71'}, {'value': '2.74', 'groupId': 'OG001', 'lowerLimit': '2.36', 'upperLimit': '3.18'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 post-vaccination', 'description': 'Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean concentrations were assessed in the per-protocol population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)'}, {'id': 'OG001', 'title': 'Group 2: Tdap Vaccine-naïve', 'description': 'Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.'}], 'classes': [{'title': 'Any Pain [N = 352, 404]', 'categories': [{'measurements': [{'value': '309', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain [N = 352, 404]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Erythema [N = 351, 404]', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Erythema [N = 351, 404]', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling [N= 352, 403]', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling [N= 352, 403]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever [N = 356, 405]', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever [N = 356, 405]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache [N = 350, 404]', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache [N = 350, 404]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise [N = 350, 404]', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise [N = 350, 404]', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia [N = 351, 404]', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia [N = 351, 404]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 7 post-vaccination', 'description': 'Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia.\n\nGrade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: \\> 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)'}, {'id': 'FG001', 'title': 'Group 2: Tdap Vaccine-naïve', 'description': 'Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '407'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '404'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 26 June 2008 to 27 February 2009 at 7 medical centers in Canada.', 'preAssignmentDetails': 'A total of 769 participants who met the inclusion and exclusion criteria were enrolled, 768 were vaccinated and evaluated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'BG000'}, {'value': '407', 'groupId': 'BG001'}, {'value': '768', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)'}, {'id': 'BG001', 'title': 'Group 2: Tdap Vaccine-naïve', 'description': 'Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '356', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '758', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '34.6', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '13.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '264', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '407', 'groupId': 'BG001'}, {'value': '768', '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': 769}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'dispFirstSubmitDate': '2011-03-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-01', 'studyFirstSubmitDate': '2008-07-07', 'dispFirstSubmitQcDate': '2011-03-01', 'resultsFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2008-07-09', 'dispFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-01', 'studyFirstPostDateStruct': {'date': '2008-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose', 'timeFrame': 'Day 30 post-vaccination', 'description': 'Anti-diphtheria or anti-tetanus booster responses were defined as:\n\nPre-vaccination antibody concentrations of \\< 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to \\< 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response.'}, {'measure': 'Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose', 'timeFrame': 'Day 30 post-vaccination', 'description': 'Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:\n\n* ≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was \\< LLOQ; or\n* ≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but \\< 4 x LLOQ; or\n* ≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ.'}, {'measure': 'Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 post-vaccination', 'description': 'Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 post-vaccination', 'description': 'Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose', 'timeFrame': 'Day 0 up to Day 7 post-vaccination', 'description': 'Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia.\n\nGrade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: \\> 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose', 'timeFrame': 'Day 0 (pre-vaccination) and 30 post-vaccination', 'description': 'Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA).\n\nSeroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL.'}, {'measure': 'Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose', 'timeFrame': 'Day 30 post-vaccination', 'description': 'Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pertussis', 'Tetanus', 'Diphtheria', 'Acellular pertussis', 'ADACEL®,', 'Tdap vaccine'], 'conditions': ['Pertussis', 'Tetanus', 'Diphtheria']}, 'referencesModule': {'references': [{'pmid': '22115634', 'type': 'RESULT', 'citation': 'Halperin SA, Scheifele D, De Serres G, Noya F, Meekison W, Zickler P, Larrivee L, Langley JM, McNeil SA, Dobson S, Jordanov E, Thakur M, Decker MD, Johnson DR. Immune responses in adults to revaccination with a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine 10 years after a previous dose. Vaccine. 2012 Jan 20;30(5):974-82. doi: 10.1016/j.vaccine.2011.11.035. Epub 2011 Nov 21.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus.\n\nPrimary Objective:\n\n* To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.', 'detailedDescription': 'This is an open-label, multicenter study to describe the immunological response and safety of repeat administration of an adolescent/adult-formulation tetanus-diphtheria-acellular pertussis Tdap vaccine (ADACEL®), 10 years following initial administration of Tdap vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria :\n\n* Received Tdap or Tdap-IPV vaccine in study TD9707 or TD9805.\n* Never previously received Tdap vaccine and has not received any tetanus-, diphtheria , or pertussis-containing vaccine in the past 10 years.\n* Participated in TD9707 or TD9805 but does not meet inclusion/ exclusion criteria or willing to undergo phlebotomy but not willing to receive Tdap (ADACEL®) vaccine.\n* Signed Institutional Review Board (IRB)-approved informed consent form\n* Able to attend all scheduled visits and to comply with all trial procedures\n* For a woman, a negative urine pregnancy test and the use of effective method(s) of contraception, or the inability to become pregnant\n\nExclusion Criteria :\n\n* Any condition listed as a contraindication in the ADACEL® Canadian product monograph\n* 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* Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator\n* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic (injected or oral) corticosteroid therapy. Individuals on a tapering dose schedule of oral steroids lasting less than 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* Febrile illness (temperature ≥ 37.5°C \\[99.5°F\\]) at the time of inclusion\n* History of documented diphtheria, pertussis, or tetanus disease since participation in studies TD9707 or TD9805. Or history of documented diphtheria, pertussis, or tetanus disease in the last 10 years.\n* Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine since participation in study TD9707 or TD9805. For Group 2, known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine in the last 10 years.\n* Receipt of any vaccine, other than influenza vaccine, in the 28-day period prior to Visit 1 or scheduled to receive any vaccine, other than influenza vaccine, in the period between Visit 1 and Visit 2. For influenza vaccine only, defer if received in the 14 days prior to enrollment or scheduled to receive prior to Visit 2.\n* Receipt of blood or blood-derived products in the past 3 months\n* Suspected or known hypersensitivity to any of the vaccine components, or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances\n* Unable to attend the scheduled visits or to comply with the study procedures\n* In females of childbearing potential, known pregnancy or positive serum/urine pregnancy test\n* Breast-feeding woman\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment. Planned participation in another clinical trial during the present trial period\n* Current alcohol or recreational drug use that may interfere with the subject's ability to comply with trial procedures\n* Thrombocytopenia, bleeding disorder, anticoagulation therapy contraindicating intramuscular (IM) vaccination\n* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.\n* Other events which in the judgment of the investigator would preclude vaccination at the time of Visit 1 For Group 3\n* History of documented diphtheria, pertussis, or tetanus disease since participation in study TD9707 or TD9805\n* Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine since participation in study TD9707 or TD9805."}, 'identificationModule': {'nctId': 'NCT00712959', 'briefTitle': 'Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immune Responses in Adults to Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose', 'orgStudyIdInfo': {'id': 'TD526'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Previous Tdap or Tdap-IPV Recipients', 'description': 'Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)', 'interventionNames': ['Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Tdap vaccine-naïve', 'description': 'Participants are age-balanced Tdap vaccine-naïve and will receive Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.', 'interventionNames': ['Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)']}, {'type': 'NO_INTERVENTION', 'label': 'Group 3', 'description': 'Past participants in Study TD9707 and TD9805 did not qualify for Tdap re-administration in this study or were unwilling to receive a second dose of Tdap. They were not included in the analysis for the study'}], 'interventions': [{'name': 'Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)', 'type': 'BIOLOGICAL', 'otherNames': ['Tdap', 'ADACEL®'], 'description': '0.5 ml, IM', 'armGroupLabels': ['Group 1: Previous Tdap or Tdap-IPV Recipients']}, {'name': 'Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)', 'type': 'BIOLOGICAL', 'otherNames': ['Tdap', 'Adacel®'], 'description': '0.5 mL, IM', 'armGroupLabels': ['Group 2: Tdap vaccine-naïve']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3C 4J2', 'city': 'Coquitlam', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.2846, 'lon': -122.78217}}, {'zip': 'V3R 8P8', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'H9H 4Y6', 'city': 'Pierrefonds', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.45989, 'lon': -73.89284}}, {'zip': 'G1E 7G9', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 4J6', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}