Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-01 @ 12:44 AM
Study NCT ID:
NCT00337428
Status:
COMPLETED
Last Update Posted:
2016-11-16
First Post:
2006-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Denmark', 'Finland', 'Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Safety results have been previously reported in the literature.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from Day 1 until Month 7.', 'description': 'AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).', 'eventGroups': [{'id': 'EG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.', 'otherNumAtRisk': 420, 'otherNumAffected': 405, 'seriousNumAtRisk': 420, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.', 'otherNumAtRisk': 423, 'otherNumAffected': 406, 'seriousNumAtRisk': 423, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 53, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 60, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site bruising-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site erythema-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 98, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 85, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site haematoma-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site induration-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site pain-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 641, 'numAffected': 335}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 630, 'numAffected': 304}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site pruritus-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site swelling-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 131, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 119, 'numAffected': 90}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site bruising-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site erythema-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 77, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 80, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site haematoma-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site induration-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site irritation-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site pain-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 383, 'numAffected': 350}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 373, 'numAffected': 346}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site pruritus-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site swelling-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 132, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 132, 'numAffected': 131}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site warmth-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 29, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 193, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 168, 'numAffected': 112}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Eating disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Listless', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Metrorrhagia', 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'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Subcutaneous nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site irritation-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site warmth-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site anaesthesia-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site discolouration-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site discolouration-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site haemorrhage-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site haemorrhage-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site mass-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site movement impairment-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site movement impairment-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site nodule-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site nodule-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site papule-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site rash-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site reaction-qHPV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Injection site reaction-Repevax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}], 'seriousEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Ligament disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1151.3', 'groupId': 'OG000', 'lowerLimit': '1007.5', 'upperLimit': '1315.7'}, {'value': '1244.9', 'groupId': 'OG001', 'lowerLimit': '1092.4', 'upperLimit': '1418.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.', 'unitOfMeasure': 'milliMerck units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1338.3', 'groupId': 'OG000', 'lowerLimit': '1209.0', 'upperLimit': '1481.4'}, {'value': '1460.7', 'groupId': 'OG001', 'lowerLimit': '1322.4', 'upperLimit': '1613.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Serum antibodies to HPV Type 11 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.', 'unitOfMeasure': 'milliMerck units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '5835.7', 'groupId': 'OG000', 'lowerLimit': '5195.7', 'upperLimit': '6554.6'}, {'value': '6508.1', 'groupId': 'OG001', 'lowerLimit': '5810.3', 'upperLimit': '7289.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Serum antibodies to HPV Type 16 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.', 'unitOfMeasure': 'milliMerck units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1096.0', 'groupId': 'OG000', 'lowerLimit': '958.8', 'upperLimit': '1252.8'}, {'value': '1308.8', 'groupId': 'OG001', 'lowerLimit': '1148.1', 'upperLimit': '1491.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Serum antibodies to HPV Type 18 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.', 'unitOfMeasure': 'milliMerck units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '367', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Seroconversion to HPV Type 6 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '367', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Seroconversion to HPV Type 11 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥16 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '370', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Seroconversion to HPV Type 16 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Seroconversion to HPV Type 18 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥24 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '380', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Diphtheria antitoxin titers were measured using a neutralization assay in Vero cell culture that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Diphtheria Antitoxin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '381', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Tetanus antitoxin titers were measured using an indirect, non-competitive enzyme immunoassay (EIA) that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Tetanus Immunoglobulin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '367', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '369', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000', 'lowerLimit': '33.2', 'upperLimit': '43.7'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '31.1', 'upperLimit': '40.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Serum antibodies to Pertussis Toxoid Antibody (anti-PT) were measured with an enzyme-linked immunosorbent assay (ELISA). Titers were reported in ELISA units/mL (ELU/mL) and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.', 'unitOfMeasure': 'ELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '140.3', 'groupId': 'OG000', 'lowerLimit': '127.5', 'upperLimit': '154.4'}, {'value': '140.7', 'groupId': 'OG001', 'lowerLimit': '127.9', 'upperLimit': '154.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Serum antibodies to Pertussis Filamentous Haemagglutin Antibody (anti-FHA) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 3.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.', 'unitOfMeasure': 'ELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '504.1', 'groupId': 'OG000', 'lowerLimit': '442.7', 'upperLimit': '574.0'}, {'value': '552.8', 'groupId': 'OG001', 'lowerLimit': '485.9', 'upperLimit': '629.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Serum antibodies to Pertussis Pertactin (anti-PRN) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.', 'unitOfMeasure': 'ELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'OG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '561.2', 'groupId': 'OG000', 'lowerLimit': '478.9', 'upperLimit': '657.7'}, {'value': '506.4', 'groupId': 'OG001', 'lowerLimit': '432.5', 'upperLimit': '592.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Serum antibodies to Pertussis Fimbrial Agglutinogens Antibody (anti-FIM) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV Type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.', 'unitOfMeasure': 'ELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'FG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '419'}, {'groupId': 'FG001', 'numSubjects': '424'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '415'}, {'groupId': 'FG001', 'numSubjects': '421'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Time', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Unwilling to Continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Anorexia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study enrolled healthy participants, 11-17 years old, with 0 lifetime sexual partners, vaccinated against diphtheria, tetanus, pertussis and polio but had not received the vaccine in the past 5 years or any prior human papillomavirus (HPV) vaccine. Additional inclusion and exclusion criteria applied.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'BG000'}, {'value': '424', 'groupId': 'BG001'}, {'value': '843', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'qHPV Vaccine + REPEVAX™ (Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.'}, {'id': 'BG001', 'title': 'qHPV Vaccine + REPEVAX™ (Non-Concomitant)', 'description': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '12.1', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '12.1', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '583', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Multi-racial', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '413', 'groupId': 'BG000'}, {'value': '415', 'groupId': 'BG001'}, {'value': '828', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 843}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2006-06-14', 'resultsFirstSubmitDate': '2010-01-14', 'studyFirstSubmitQcDate': '2006-06-15', 'lastUpdatePostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-14', 'studyFirstPostDateStruct': {'date': '2006-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.'}, {'measure': 'Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3)', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Serum antibodies to HPV Type 11 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.'}, {'measure': 'Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3)', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Serum antibodies to HPV Type 16 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.'}, {'measure': 'Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3)', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Serum antibodies to HPV Type 18 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.'}, {'measure': 'Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Seroconversion to HPV Type 6 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.'}, {'measure': 'Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3)', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Seroconversion to HPV Type 11 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥16 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.'}, {'measure': 'Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Seroconversion to HPV Type 16 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.'}, {'measure': 'Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3)', 'timeFrame': 'Up to 7 Months (4 Weeks Postdose 3)', 'description': 'Seroconversion to HPV Type 18 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥24 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.'}, {'measure': 'Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Diphtheria antitoxin titers were measured using a neutralization assay in Vero cell culture that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Diphtheria Antitoxin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.'}, {'measure': 'Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Tetanus antitoxin titers were measured using an indirect, non-competitive enzyme immunoassay (EIA) that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Tetanus Immunoglobulin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.'}, {'measure': 'Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.'}, {'measure': 'Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.'}, {'measure': 'Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.'}, {'measure': 'Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Serum antibodies to Pertussis Toxoid Antibody (anti-PT) were measured with an enzyme-linked immunosorbent assay (ELISA). Titers were reported in ELISA units/mL (ELU/mL) and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.'}, {'measure': 'Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Serum antibodies to Pertussis Filamentous Haemagglutin Antibody (anti-FHA) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 3.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.'}, {'measure': 'Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Serum antibodies to Pertussis Pertactin (anti-PRN) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.'}, {'measure': 'Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™', 'timeFrame': 'Up to 1 Month (1 Month Postdose 1)', 'description': 'Serum antibodies to Pertussis Fimbrial Agglutinogens Antibody (anti-FIM) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV Type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.'}]}, 'conditionsModule': {'conditions': ['Neoplasms, Glandular and Epithelial', 'Diphtheria', 'Tetanus', 'Whooping Cough', 'Poliomyelitis']}, 'referencesModule': {'references': [{'pmid': '19952980', 'type': 'RESULT', 'citation': 'Vesikari T, Van Damme P, Lindblad N, Pfletschinger U, Radley D, Ryan D, Vuocolo S, Haupt RM, Guris D. An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) vaccine given concomitantly with diphtheria, tetanus, pertussis, and poliomyelitis vaccine in healthy adolescents 11 to 17 years of age. Pediatr Infect Dis J. 2010 Apr;29(4):314-8. doi: 10.1097/INF.0b013e3181c177fb.'}]}, 'descriptionModule': {'briefSummary': 'Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus \\[Types 6, 11, 16, 18\\] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be healthy boys or girls, 11-17 years of age\n* Must be a virgin with no intention of becoming sexually active during the study period\n* Must have been properly vaccinated against diphtheria, tetanus, pertussis and polio\n\nExclusion Criteria:\n\n* Must not have received a vaccine against diphtheria, tetanus, pertussis and polio in the past 5 years\n* Must not have received any prior human papillomavirus (HPV) vaccine'}, 'identificationModule': {'nctId': 'NCT00337428', 'briefTitle': 'Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Gardasil (V501) Given Concomitantly With REPEVAX™ in Healthy Adolescents 11-17 Years of Age', 'orgStudyIdInfo': {'id': 'V501-024'}, 'secondaryIdInfos': [{'id': '2005_093'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Concomitant/CMF', 'interventionNames': ['Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)', 'Biological: Comparator: REPEVAX™ (Concomitant)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Non-Concomitant/CMF', 'interventionNames': ['Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)', 'Biological: Comparator: REPEVAX™ (Non-Concomitant)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Concomitant/FMF', 'interventionNames': ['Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)', 'Biological: Comparator: REPEVAX™ (Concomitant)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Non-Concomitant/FMF', 'interventionNames': ['Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)', 'Biological: Comparator: REPEVAX™ (Non-Concomitant)']}], 'interventions': [{'name': 'Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)', 'type': 'BIOLOGICAL', 'description': 'GARDASIL™ (quadrivalent human papillomavirus \\[types 6, 11, 16, 18\\] virus-like particle \\[VLP\\] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)', 'type': 'BIOLOGICAL', 'description': 'GARDASIL™ (quadrivalent human papillomavirus \\[types 6, 11, 16, 18\\] virus-like particle \\[VLP\\] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.', 'armGroupLabels': ['Group 3', 'Group 4']}, {'name': 'Comparator: REPEVAX™ (Concomitant)', 'type': 'BIOLOGICAL', 'description': 'REPEVAX™ (diphtheria, tetanus, pertussis \\[acellular, component\\] and poliomyelitis \\[inactivated\\] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.', 'armGroupLabels': ['Group 1', 'Group 3']}, {'name': 'Comparator: REPEVAX™ (Non-Concomitant)', 'type': 'BIOLOGICAL', 'description': 'REPEVAX™ (diphtheria, tetanus, pertussis \\[acellular, component\\] and poliomyelitis \\[inactivated\\] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.', 'armGroupLabels': ['Group 2', 'Group 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}