Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-02 @ 8:18 AM
Study NCT ID:
NCT02587520
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
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': 'D013745', 'term': 'Tetanus Toxoid'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi Pasteur'}, 'certainAgreement': {'otherDetails': 'The 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': 'Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.', 'description': 'A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Adolescents: SP0173 Formulation 1', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 71, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Adolescents: SP0173 Formulation 2', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 64, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Adolescents: SP0173 Formulation 3', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 67, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Adolescents: SP0173 Formulation 4', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 68, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Adolescents: Adacel®', 'description': 'Healthy participants aged 10-18 years received Adacel®.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 71, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Adolescents: Boostrix®', 'description': 'Healthy participants aged 10-18 years received Boostrix®.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 66, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Adults: SP0173 Formulation 1', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 52, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Adults: SP0173 Formulation 2', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 53, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Adults: SP0173 Formulation 3', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 67, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'Adults: SP0173 Formulation 4', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 54, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Adults: Adacel®', 'description': 'Healthy participants aged 19-64 years received Adacel®.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 62, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Adults: Boostrix®', 'description': 'Healthy participants aged 19-64 years received Boostrix®.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 50, 'seriousNumAtRisk': 72, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG012', 'title': 'Older Adults: SP0173 Formulation 1', 'description': 'Healthy participants aged \\>= 65 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 53, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Older Adults: SP0173 Formulation 2', 'description': 'Healthy participants aged \\>= 65 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 60, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG014', 'title': 'Older Adults: SP0173 Formulation 3', 'description': 'Healthy participants aged \\>= 65 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 58, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG015', 'title': 'Older Adults: SP0173 Formulation 4', 'description': 'Healthy participants aged \\>= 65 years received a single dose of the SP0173 Tdap vaccine.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 53, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG016', 'title': 'Older Adults: Adacel®', 'description': 'Healthy participants aged \\>= 65 years received Adacel®.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 49, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG017', 'title': 'Older Adults: Boostrix®', 'description': 'Healthy participants aged \\>= 65 years received Boostrix®.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 56, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Change In Limb Circumference', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 45, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 49, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 48, 'numAffected': 48}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 40, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 59, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 51, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 49, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 59, 'numAffected': 59}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 48, 'numAffected': 48}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 49, 'numAffected': 49}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 42, 'numAffected': 42}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 49, 'numAffected': 49}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Viral Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 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Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 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'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 1, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '75', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: SP0173 Formulation 1', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.'}, {'id': 'OG001', 'title': 'Adolescents: SP0173 Formulation 2', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG002', 'title': 'Adolescents: SP0173 Formulation 3', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG003', 'title': 'Adolescents: SP0173 Formulation 4', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG004', 'title': 'Adolescents: Adacel®', 'description': 'Healthy participants aged 10-18 years received Adacel®.'}, {'id': 'OG005', 'title': 'Adolescents: Boostrix®', 'description': 'Healthy participants aged 10-18 years received Boostrix®.'}], 'classes': [{'title': 'Injection site pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}]}]}, {'title': 'Injection site erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Injection site swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Upper limb edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}]}, {'title': 'Extensive limb swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '75', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}]}, {'title': 'Malaise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}]}, {'title': 'Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after vaccination', 'description': 'A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature \\& onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set that was defined as those participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, "number analyzed"= number of participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '72', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults: SP0173 Formulation 1', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG001', 'title': 'Adults: SP0173 Formulation 2', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG002', 'title': 'Adults: SP0173 Formulation 3', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG003', 'title': 'Adults: SP0173 Formulation 4', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG004', 'title': 'Adults: Adacel®', 'description': 'Healthy participants aged 19-64 years received Adacel®.'}, {'id': 'OG005', 'title': 'Adults: Boostrix®', 'description': 'Healthy participants aged 19-64 years received Boostrix®.'}], 'classes': [{'title': 'Injection site pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}]}, {'title': 'Injection site erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Injection site swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Upper limb edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}]}, {'title': 'Extensive limb swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '72', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'Malaise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}, {'title': 'Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after vaccination', 'description': 'An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set. Here, "number analyzed"=number of participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Older Adults: SP0173 Formulation 1', 'description': 'Healthy participants aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG001', 'title': 'Older Adults: SP0173 Formulation 2', 'description': 'Healthy participants aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG002', 'title': 'Older Adults: SP0173 Formulation 3', 'description': 'Healthy participants aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG003', 'title': 'Older Adults: SP0173 Formulation 4', 'description': 'Healthy participants aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'OG004', 'title': 'Older Adults: Adacel®', 'description': 'Healthy participants aged \\>=65 years received Adacel®.'}, {'id': 'OG005', 'title': 'Older Adults: Boostrix®', 'description': 'Healthy participants aged \\>=65 years received Boostrix®.'}], 'classes': [{'title': 'Injection site pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}]}, {'title': 'Injection site erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Injection site swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Upper limb edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '74', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}]}, {'title': 'Extensive limb swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '74', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '77', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'Malaise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '77', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '77', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after vaccination', 'description': 'An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set. Here, "number analyzed"=number of participants with available data for each specified category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adolescents: SP0173 Formulation 1', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.'}, {'id': 'FG001', 'title': 'Adolescents: SP0173 Formulation 2', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG002', 'title': 'Adolescents: SP0173 Formulation 3', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG003', 'title': 'Adolescents: SP0173 Formulation 4', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG004', 'title': 'Adolescents: Adacel®', 'description': 'Healthy participants aged 10-18 years received Adacel®.'}, {'id': 'FG005', 'title': 'Adolescents: Boostrix®', 'description': 'Healthy participants aged 10-18 years received Boostrix®.'}, {'id': 'FG006', 'title': 'Adults: SP0173 Formulation 1', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG007', 'title': 'Adults: SP0173 Formulation 2', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG008', 'title': 'Adults: SP0173 Formulation 3', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG009', 'title': 'Adults: SP0173 Formulation 4', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG010', 'title': 'Adults: Adacel®', 'description': 'Healthy participants aged 19-64 years received Adacel®.'}, {'id': 'FG011', 'title': 'Adults: Boostrix®', 'description': 'Healthy participants aged 19-64 years received Boostrix®.'}, {'id': 'FG012', 'title': 'Older Adults: SP0173 Formulation 1', 'description': 'Healthy participants aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG013', 'title': 'Older Adults: SP0173 Formulation 2', 'description': 'Healthy participants aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG014', 'title': 'Older Adults: SP0173 Formulation 3', 'description': 'Healthy subjects aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG015', 'title': 'Older Adults: SP0173 Formulation 4', 'description': 'Healthy subjects aged \\>= 65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'FG016', 'title': 'Older Adults: Adacel®', 'description': 'Healthy participants aged \\>=65 years received Adacel®.'}, {'id': 'FG017', 'title': 'Older Adults: Boostrix®', 'description': 'Healthy participants aged \\>=65 years received Boostrix®.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '79'}, {'groupId': 'FG004', 'numSubjects': '75'}, {'groupId': 'FG005', 'numSubjects': '75'}, {'groupId': 'FG006', 'numSubjects': '76'}, {'groupId': 'FG007', 'numSubjects': '73'}, {'groupId': 'FG008', 'numSubjects': '76'}, {'groupId': 'FG009', 'numSubjects': '76'}, {'groupId': 'FG010', 'numSubjects': '76'}, {'groupId': 'FG011', 'numSubjects': '73'}, {'groupId': 'FG012', 'numSubjects': '77'}, {'groupId': 'FG013', 'numSubjects': '74'}, {'groupId': 'FG014', 'numSubjects': '78'}, {'groupId': 'FG015', 'numSubjects': '72'}, {'groupId': 'FG016', 'numSubjects': '76'}, {'groupId': 'FG017', 'numSubjects': '78'}]}, {'type': 'Safety Analysis Set (SafAS)', 'comment': 'All participants who received study vaccine, analyzed according to vaccine actually received.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '77'}, {'groupId': 'FG003', 'numSubjects': '77'}, {'groupId': 'FG004', 'numSubjects': '75'}, {'groupId': 'FG005', 'numSubjects': '75'}, {'groupId': 'FG006', 'numSubjects': '76'}, {'groupId': 'FG007', 'numSubjects': '73'}, {'groupId': 'FG008', 'numSubjects': '76'}, {'groupId': 'FG009', 'numSubjects': '76'}, {'groupId': 'FG010', 'numSubjects': '76'}, {'groupId': 'FG011', 'numSubjects': '72'}, {'groupId': 'FG012', 'numSubjects': '77'}, {'groupId': 'FG013', 'numSubjects': '73'}, {'groupId': 'FG014', 'numSubjects': '78'}, {'groupId': 'FG015', 'numSubjects': '72'}, {'groupId': 'FG016', 'numSubjects': '76'}, {'groupId': 'FG017', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '77'}, {'groupId': 'FG003', 'numSubjects': '74'}, {'groupId': 'FG004', 'numSubjects': '75'}, {'groupId': 'FG005', 'numSubjects': '72'}, {'groupId': 'FG006', 'numSubjects': '73'}, {'groupId': 'FG007', 'numSubjects': '71'}, {'groupId': 'FG008', 'numSubjects': '73'}, {'groupId': 'FG009', 'numSubjects': '71'}, {'groupId': 'FG010', 'numSubjects': '73'}, {'groupId': 'FG011', 'numSubjects': '69'}, {'groupId': 'FG012', 'numSubjects': '77'}, {'groupId': 'FG013', 'numSubjects': '73'}, {'groupId': 'FG014', 'numSubjects': '78'}, {'groupId': 'FG015', 'numSubjects': '72'}, {'groupId': 'FG016', 'numSubjects': '76'}, {'groupId': 'FG017', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were enrolled in 20 centers in the Unites States (US) from 22 October 2015 to 15 August 2016.', 'preAssignmentDetails': 'A total of 1363 participants were randomized in a 1:1:1 ratio to 1 of the 6 formulation study groups. Randomization was stratified by age (adolescents: age 10-18 years, adults: age 19-64 years, and older adults: age greater than equal to \\[\\>=\\] 65 years).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}, {'value': '75', 'groupId': 'BG005'}, {'value': '76', 'groupId': 'BG006'}, {'value': '73', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}, {'value': '76', 'groupId': 'BG009'}, {'value': '76', 'groupId': 'BG010'}, {'value': '73', 'groupId': 'BG011'}, {'value': '77', 'groupId': 'BG012'}, {'value': '74', 'groupId': 'BG013'}, {'value': '78', 'groupId': 'BG014'}, {'value': '72', 'groupId': 'BG015'}, {'value': '76', 'groupId': 'BG016'}, {'value': '78', 'groupId': 'BG017'}, {'value': '1363', 'groupId': 'BG018'}]}], 'groups': [{'id': 'BG000', 'title': 'Adolescents: SP0173 Formulation 1', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.'}, {'id': 'BG001', 'title': 'Adolescents: SP0173 Formulation 2', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG002', 'title': 'Adolescents: SP0173 Formulation 3', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG003', 'title': 'Adolescents: SP0173 Formulation 4', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG004', 'title': 'Adolescents: Adacel®', 'description': 'Healthy participants aged 10-18 years received Adacel®.'}, {'id': 'BG005', 'title': 'Adolescents: Boostrix®', 'description': 'Healthy participants aged 10-18 years received Boostrix®.'}, {'id': 'BG006', 'title': 'Adults: SP0173 Formulation 1', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG007', 'title': 'Adults: SP0173 Formulation 2', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG008', 'title': 'Adults: SP0173 Formulation 3', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG009', 'title': 'Adults: SP0173 Formulation 4', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG010', 'title': 'Adults: Adacel®', 'description': 'Healthy participants aged 19-64 years received Adacel®.'}, {'id': 'BG011', 'title': 'Adults: Boostrix®', 'description': 'Healthy participants aged 19-64 years received Boostrix®.'}, {'id': 'BG012', 'title': 'Older Adults: SP0173 Formulation 1', 'description': 'Healthy participants aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG013', 'title': 'Older Adults: SP0173 Formulation 2', 'description': 'Healthy participants aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG014', 'title': 'Older Adults: SP0173 Formulation 3', 'description': 'Healthy subjects aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG015', 'title': 'Older Adults: SP0173 Formulation 4', 'description': 'Healthy subjects aged \\>= 65 years received a single dose of the SP0173 Tdap vaccine.'}, {'id': 'BG016', 'title': 'Older Adults: Adacel®', 'description': 'Healthy participants aged \\>=65 years received Adacel®.'}, {'id': 'BG017', 'title': 'Older Adults: Boostrix®', 'description': 'Healthy participants aged \\>=65 years received Boostrix®.'}, {'id': 'BG018', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '11.0', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '11.1', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '10.8', 'spread': '1.4', 'groupId': 'BG003'}, {'value': '10.8', 'spread': '1.5', 'groupId': 'BG004'}, {'value': '11.1', 'spread': '1.6', 'groupId': 'BG005'}, {'value': '42.5', 'spread': '12.5', 'groupId': 'BG006'}, {'value': '41.2', 'spread': '12.1', 'groupId': 'BG007'}, {'value': '40.1', 'spread': '12.8', 'groupId': 'BG008'}, {'value': '42.1', 'spread': '13.0', 'groupId': 'BG009'}, {'value': '41.3', 'spread': '12.7', 'groupId': 'BG010'}, {'value': '42.5', 'spread': '13.2', 'groupId': 'BG011'}, {'value': '71.3', 'spread': '5.4', 'groupId': 'BG012'}, {'value': '71.8', 'spread': '5.4', 'groupId': 'BG013'}, {'value': '70.9', 'spread': '4.8', 'groupId': 'BG014'}, {'value': '70.8', 'spread': '5.1', 'groupId': 'BG015'}, {'value': '70.9', 'spread': '5.0', 'groupId': 'BG016'}, {'value': '71.3', 'spread': '4.8', 'groupId': 'BG017'}, {'value': '41.2', 'spread': '25.9', 'groupId': 'BG018'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}, {'value': '46', 'groupId': 'BG007'}, {'value': '38', 'groupId': 'BG008'}, {'value': '39', 'groupId': 'BG009'}, {'value': '44', 'groupId': 'BG010'}, {'value': '36', 'groupId': 'BG011'}, {'value': '37', 'groupId': 'BG012'}, {'value': '38', 'groupId': 'BG013'}, {'value': '51', 'groupId': 'BG014'}, {'value': '38', 'groupId': 'BG015'}, {'value': '46', 'groupId': 'BG016'}, {'value': '45', 'groupId': 'BG017'}, {'value': '726', 'groupId': 'BG018'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}, {'value': '38', 'groupId': 'BG008'}, {'value': '37', 'groupId': 'BG009'}, {'value': '32', 'groupId': 'BG010'}, {'value': '37', 'groupId': 'BG011'}, {'value': '40', 'groupId': 'BG012'}, {'value': '36', 'groupId': 'BG013'}, {'value': '27', 'groupId': 'BG014'}, {'value': '34', 'groupId': 'BG015'}, {'value': '30', 'groupId': 'BG016'}, {'value': '33', 'groupId': 'BG017'}, {'value': '637', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}, {'value': '15', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '12', 'groupId': 'BG013'}, {'value': '13', 'groupId': 'BG014'}, {'value': '15', 'groupId': 'BG015'}, {'value': '12', 'groupId': 'BG016'}, {'value': '13', 'groupId': 'BG017'}, {'value': '179', 'groupId': 'BG018'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}, {'value': '69', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}, {'value': '54', 'groupId': 'BG007'}, {'value': '68', 'groupId': 'BG008'}, {'value': '65', 'groupId': 'BG009'}, {'value': '61', 'groupId': 'BG010'}, {'value': '63', 'groupId': 'BG011'}, {'value': '64', 'groupId': 'BG012'}, {'value': '59', 'groupId': 'BG013'}, {'value': '64', 'groupId': 'BG014'}, {'value': '55', 'groupId': 'BG015'}, {'value': '63', 'groupId': 'BG016'}, {'value': '61', 'groupId': 'BG017'}, {'value': '1171', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '13', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '8', 'groupId': 'BG018'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '16', 'groupId': 'BG018'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '3', 'groupId': 'BG018'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}, {'value': '18', 'groupId': 'BG009'}, {'value': '23', 'groupId': 'BG010'}, {'value': '19', 'groupId': 'BG011'}, {'value': '7', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '8', 'groupId': 'BG014'}, {'value': '5', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '10', 'groupId': 'BG017'}, {'value': '203', 'groupId': 'BG018'}]}, {'title': 'White', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}, {'value': '65', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}, {'value': '51', 'groupId': 'BG007'}, {'value': '46', 'groupId': 'BG008'}, {'value': '53', 'groupId': 'BG009'}, {'value': '52', 'groupId': 'BG010'}, {'value': '51', 'groupId': 'BG011'}, {'value': '69', 'groupId': 'BG012'}, {'value': '64', 'groupId': 'BG013'}, {'value': '70', 'groupId': 'BG014'}, {'value': '66', 'groupId': 'BG015'}, {'value': '69', 'groupId': 'BG016'}, {'value': '68', 'groupId': 'BG017'}, {'value': '1109', 'groupId': 'BG018'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '24', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-13', 'size': 902086, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-18T11:22', 'hasProtocol': True}, {'date': '2016-12-13', 'size': 622764, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-18T07:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1363}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2018-02-19', 'completionDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2015-10-22', 'dispFirstSubmitQcDate': '2018-02-19', 'resultsFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2015-10-23', 'dispFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-18', 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years', 'timeFrame': 'Within 7 days after vaccination', 'description': 'A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature \\& onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.'}, {'measure': 'Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years', 'timeFrame': 'Within 7 days after vaccination', 'description': 'An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.'}, {'measure': 'Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years', 'timeFrame': 'Within 7 days after vaccination', 'description': 'An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tetanus', 'Diphtheria', 'Pertussis', 'SP0173', 'Tdap vaccine'], 'conditions': ['Tetanus', 'Diphtheria', 'Pertussis', 'Whooping Cough']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This was a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the United States (US).\n\nPrimary Objective\n\n* To describe the safety profile of each SP0173 investigational formulation.\n\nObservational Objective:\n\n* To describe the immunogenicity of each SP0173 investigational formulation.', 'detailedDescription': 'All participants received a single dose of vaccine, and were assessed for immunogenicity at baseline (pre-vaccination) and at 30 days post-vaccination. They were also monitored for safety from day of vaccination up to Day 180 post-vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 10 to 18 years, 19 to 64 years, or \\>= 65 years on the day of inclusion.\n* Informed consent form had been signed and dated by the participant, or assent form had been signed and dated by the participant and informed consent form had been signed and dated by the parent/guardian\n* Participant or participant and parent/guardian able to attend all scheduled visits and to comply with all study procedures.\n\nExclusion Criteria:\n\n* Participant was pregnant, or lactating, or of childbearing potential, (to be considered of non-childbearing potential, a female must be premenarche or post-menopausal for at least 1 year) surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.\n* Participation at the time of study enrollment or planned participation during the present study period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.\n* Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine between Visit 1 and Visit 2.\n* Known or suspected receipt of a tetanus toxoid, reduced diphtheria toxoid, and Acellular pertussis (Tdap) vaccine or Tdap-containing vaccine at any point in time, or receipt of a tetanus and diphtheria containing vaccine in the preceding 5 years.\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months.\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 corticosteroids therapy.\n* History of diphtheria, tetanus, or pertussis infection (confirmed either serologically or microbiologically).\n* Known or suspected systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the study vaccine or a vaccine containing the same substances.\n* Laboratory-confirmed / self-reported thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.\n* History of encephalopathy (e.g., coma, decreased level of consciousness, or prolonged seizures) not attributable to another identifiable cause within 7 days of administration of a previous dose of diphtheria and tetanus toxoids and pertussis (DTP), or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine.\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.\n* Current alcohol abuse or drug addiction.\n* Chronic illness that was at a stage where it might interfere with trial conduct or completion.\n* Moderate or severe acute illness/infection on the day of vaccination or febrile illness (temperature \\>= 100.4°F).\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': 'NCT02587520', 'briefTitle': 'Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults', 'orgStudyIdInfo': {'id': 'ADC01'}, 'secondaryIdInfos': [{'id': 'U1111-1161-3027', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adolescents: SP0173 Formulation 1', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'Adolescents: SP0173 Formulation 2', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2']}, {'type': 'EXPERIMENTAL', 'label': 'Adolescents: SP0173 Formulation 3', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3']}, {'type': 'EXPERIMENTAL', 'label': 'Adolescents: SP0173 Formulation 4', 'description': 'Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adolescents: Adacel®', 'description': 'Healthy participants aged 10-18 years received Adacel®.', 'interventionNames': ['Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adolescents: Boostrix®', 'description': 'Healthy participants aged 10-18 years received Boostrix®.', 'interventionNames': ['Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Adults: SP0173 Formulation 1', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'Adults: SP0173 Formulation 2', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2']}, {'type': 'EXPERIMENTAL', 'label': 'Adults: SP0173 Formulation 3', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3']}, {'type': 'EXPERIMENTAL', 'label': 'Adults: SP0173 Formulation 4', 'description': 'Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adults: Adacel®', 'description': 'Healthy participants aged 19-64 years received Adacel®.', 'interventionNames': ['Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adults: Boostrix®', 'description': 'Healthy participants aged 19-64 years received Boostrix®.', 'interventionNames': ['Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Older Adults: SP0173 Formulation 1', 'description': 'Healthy participants aged greater than equal to (\\>=65) years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'Older Adults: SP0173 Formulation 2', 'description': 'Healthy participants aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2']}, {'type': 'EXPERIMENTAL', 'label': 'Older Adults: SP0173 Formulation 3', 'description': 'Healthy participants aged \\>=65 years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3']}, {'type': 'EXPERIMENTAL', 'label': 'Older Adults: SP0173 Formulation 4', 'description': 'Healthy participants aged \\>= 65 years received a single dose of the SP0173 Tdap vaccine.', 'interventionNames': ['Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Older Adults: Adacel®', 'description': 'Healthy participants aged \\>=65 years received Adacel®.', 'interventionNames': ['Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Older Adults: Boostrix®', 'description': 'Healthy participants aged \\>=65 years received Boostrix®.', 'interventionNames': ['Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine']}], 'interventions': [{'name': 'Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1', 'type': 'BIOLOGICAL', 'otherNames': ['SP0173'], 'description': '0.5 milliliter (mL), Intramuscular', 'armGroupLabels': ['Adolescents: SP0173 Formulation 1', 'Adults: SP0173 Formulation 1', 'Older Adults: SP0173 Formulation 1']}, {'name': 'Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2', 'type': 'BIOLOGICAL', 'otherNames': ['SP0173'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Adolescents: SP0173 Formulation 2', 'Adults: SP0173 Formulation 2', 'Older Adults: SP0173 Formulation 2']}, {'name': 'Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3', 'type': 'BIOLOGICAL', 'otherNames': ['SP0173'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Adolescents: SP0173 Formulation 3', 'Adults: SP0173 Formulation 3', 'Older Adults: SP0173 Formulation 3']}, {'name': 'Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4', 'type': 'BIOLOGICAL', 'otherNames': ['SP0173'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Adolescents: SP0173 Formulation 4', 'Adults: SP0173 Formulation 4', 'Older Adults: SP0173 Formulation 4']}, {'name': 'Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Adolescents: Adacel®', 'Adults: Adacel®', 'Older Adults: Adacel®']}, {'name': 'Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Adolescents: Boostrix®', 'Adults: Boostrix®', 'Older Adults: Boostrix®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 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Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}