Viewing Study NCT01461993

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Ignite Creation Date: 2025-12-25 @ 1:27 AM
Ignite Modification Date: 2025-12-27 @ 11:14 PM
Study NCT ID: NCT01461993
Status: COMPLETED
Last Update Posted: 2018-12-19
First Post: 2011-09-28
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068857', 'term': 'Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18'}, {'id': 'C484699', 'term': 'factor H-binding protein, Neisseria meningitidis'}], 'ancestors': [{'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D053918', 'term': 'Papillomavirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)', 'description': 'Events collected on case report form were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule', 'otherNumAtRisk': 992, 'otherNumAffected': 308, 'seriousNumAtRisk': 992, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Group 2: rLP2086 + Saline', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule', 'otherNumAtRisk': 990, 'otherNumAffected': 289, 'seriousNumAtRisk': 990, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Group 3: Saline + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule', 'otherNumAtRisk': 501, 'otherNumAffected': 168, 'seriousNumAtRisk': 501, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Viral pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Lymphoid tissue hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Burns first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Epiphysiolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nodular fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cyclothymic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oppositional defiant disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 992, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 501, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '813', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'OG001', 'title': 'Group 3: Saline + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}], 'classes': [{'title': 'HPV-6', 'categories': [{'measurements': [{'value': '451.8', 'groupId': 'OG000', 'lowerLimit': '417.50', 'upperLimit': '489.01'}, {'value': '550.3', 'groupId': 'OG001', 'lowerLimit': '490.44', 'upperLimit': '617.58'}]}]}, {'title': 'HPV-11', 'categories': [{'measurements': [{'value': '892.9', 'groupId': 'OG000', 'lowerLimit': '839.52', 'upperLimit': '949.57'}, {'value': '1084.3', 'groupId': 'OG001', 'lowerLimit': '997.28', 'upperLimit': '1178.96'}]}]}, {'title': 'HPV-16', 'categories': [{'measurements': [{'value': '3695.4', 'groupId': 'OG000', 'lowerLimit': '3426.32', 'upperLimit': '3985.67'}, {'value': '4763.4', 'groupId': 'OG001', 'lowerLimit': '4285.85', 'upperLimit': '5294.21'}]}]}, {'title': 'HPV-18', 'categories': [{'measurements': [{'value': '744.0', 'groupId': 'OG000', 'lowerLimit': '687.67', 'upperLimit': '804.96'}, {'value': '1047.4', 'groupId': 'OG001', 'lowerLimit': '939.00', 'upperLimit': '1168.25'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.94', 'groupDescription': 'HPV-6', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority criteria margin was 1.5-fold.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.91', 'groupDescription': 'HPV-11', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority criteria margin was 1.5-fold.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.88', 'groupDescription': 'HPV-16', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority criteria margin was 1.5-fold.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.81', 'groupDescription': 'HPV-18', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority criteria margin was 1.5-fold.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after Vaccination 3', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '814', 'groupId': 'OG000'}, {'value': '812', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'OG001', 'title': 'Group 2: rLP2086 + Saline', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}], 'classes': [{'title': 'PMB80 [A22] (N= 803, 801)', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '50.22', 'upperLimit': '56.66'}, {'value': '57.8', 'groupId': 'OG001', 'lowerLimit': '54.44', 'upperLimit': '61.44'}]}]}, {'title': 'PMB2948 [B24] (N= 788, 793)', 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000', 'lowerLimit': '24.14', 'upperLimit': '27.56'}, {'value': '28.0', 'groupId': 'OG001', 'lowerLimit': '26.24', 'upperLimit': '29.87'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.00', 'groupDescription': 'PMB80 \\[A22\\]', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority criteria margin was 1.5-fold.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.01', 'groupDescription': 'PMB2948 \\[B24\\]', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority criteria margin was 1.5-fold.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after Vaccination 3', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '809', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'OG001', 'title': 'Group 3: Saline + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}], 'classes': [{'title': 'HPV-6 (N= 802, 414)', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-11 (N= 801, 417)', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000'}, {'value': '99.5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 (N= 800, 413)', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000'}, {'value': '99.5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 (N= 805, 418)', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}, {'value': '99.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 3', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '814', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'OG001', 'title': 'Group 3: Saline + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}], 'classes': [{'title': 'HPV-6', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-11', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '814', 'groupId': 'OG000'}, {'value': '812', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'OG001', 'title': 'Group 2: rLP2086 + Saline', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}], 'classes': [{'title': 'Before Vaccination 1:PMB80[A22] 1:16 (N= 794, 799)', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB80[A22] 1:16 (N= 794, 801)', 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000'}, {'value': '85.8', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB80[A22] 1:16 (N= 803, 801)', 'categories': [{'measurements': [{'value': '94.0', 'groupId': 'OG000'}, {'value': '96.3', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1:PMB2001[A56] 1:8(N= 757, 740)', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2001[A56] 1:8 (N= 790,795)', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000'}, {'value': '98.5', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2001[A56] 1:8 (N= 796,802)', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '99.4', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1:PMB2948[B24] 1:8(N= 801, 793)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2948[B24] 1:8 (N= 770,770)', 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}, {'value': '74.2', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2948[B24] 1:8 (N= 788,793)', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000'}, {'value': '92.6', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1:PMB2707[B44] 1:8(N= 806, 805)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2707[B44] 1:8 (N= 783,776)', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2707[B44] 1:8 (N= 799,795)', 'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination 1, 1 month after vaccination (Vac) 2, 3', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '814', 'groupId': 'OG000'}, {'value': '812', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'OG001', 'title': 'Group 2: rLP2086 + Saline', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}], 'classes': [{'title': 'Before Vaccination 1: PMB80 [A22] 1:4 (N=794,799)', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB80 [A22] 1:8 (N=794,799)', 'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB80 [A22] 1:32 (N=794,799)', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB80 [A22] 1:64 (N=794,799)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB80[A22] 1:128 (N=794,799)', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB80 [A22] 1:4 (N=794,801)', 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000'}, {'value': '86.3', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB80 [A22] 1:8 (N=794,801)', 'categories': [{'measurements': [{'value': '83.2', 'groupId': 'OG000'}, {'value': '86.1', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB80 [A22] 1:32 (N=794,801)', 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000'}, {'value': '69.7', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB80 [A22] 1:64 (N=794,801)', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}, {'value': '35.8', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB80 [A22] 1:128 (N=794,801)', 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}, {'value': '13.0', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB80 [A22] 1:4 (N=803,801)', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}, {'value': '96.4', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB80 [A22] 1:8 (N=803,801)', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}, {'value': '96.4', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB80 [A22] 1:32 (N=803,801)', 'categories': [{'measurements': [{'value': '86.3', 'groupId': 'OG000'}, {'value': '87.0', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB80 [A22] 1:64 (N=803,801)', 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000'}, {'value': '61.0', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB80 [A22] 1:128 (N=803,801)', 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000'}, {'value': '31.6', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2001[A56] 1:4 (N=757,740)', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2001[A56] 1:16(N=757,740)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2001[A56] 1:32(N=757,740)', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2001[A56] 1:64(N=757,740)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1:PMB2001[A56] 1:128(N=757,740)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2001 [A56] 1:4 (N=790,795)', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000'}, {'value': '98.7', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2001[A56] 1:16 (N=790,795)', 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}, {'value': '98.4', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2001[A56] 1:32 (N=790,795)', 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000'}, {'value': '93.7', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2001[A56] 1:64 (N=790,795)', 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000'}, {'value': '76.6', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2001[A56] 1:128(N=790,795)', 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000'}, {'value': '41.5', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2001 [A56] 1:4 (n=796,802)', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '99.4', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2001[A56] 1:16 (N=796,802)', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '99.4', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2001[A56] 1:32 (N=796,802)', 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}, {'value': '97.3', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2001[A56] 1:64 (N=796,802)', 'categories': [{'measurements': [{'value': '88.1', 'groupId': 'OG000'}, {'value': '89.2', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2001[A56] 1:128(N=796,802)', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '67.2', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2948[B24] 1:4 (N=801,793)', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2948[B24] 1:16(N=801,793)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2948[B24] 1:32(N=801,793)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2948[B24] 1:64(N=801,793)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1:PMB2948[B24] 1:128(N=801,793)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2948 [B24] 1:4 (N=770,770)', 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000'}, {'value': '77.1', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2948[B24] 1:16 (N=770,770)', 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000'}, {'value': '68.8', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2948[B24] 1:32 (N=770,770)', 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000'}, {'value': '38.7', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2948[B24] 1:64 (N=770,770)', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2948[B24] 1:128(N=770,770)', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2948 [B24] 1:4 (N=788,793)', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000'}, {'value': '92.8', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2948[B24] 1:16 (N=788,793)', 'categories': [{'measurements': [{'value': '86.3', 'groupId': 'OG000'}, {'value': '89.2', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2948[B24] 1:32 (N=788,793)', 'categories': [{'measurements': [{'value': '57.2', 'groupId': 'OG000'}, {'value': '60.9', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2948[B24] 1:64 (N=788,793)', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '25.2', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2948[B24] 1:128(N=788,793)', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2707[B44] 1:4 (N=806,805)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2707[B44] 1:16(N=806,805)', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2707[B44] 1:32(N=806,805)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1: PMB2707[B44] 1:64(N=806,805)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Before Vaccination 1:PMB2707[B44] 1:128(N=806,805)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2707 [B44] 1:4 (N=783,776)', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '60.1', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2707[B44] 1:16 (N=783,776)', 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}, {'value': '49.9', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2707[B44] 1:32 (N=783,776)', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000'}, {'value': '26.9', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2707[B44] 1:64 (N=783,776)', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 2: PMB2707[B44] 1:128(N=783,776)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2707 [B44] 1:4 (N=799,795)', 'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000'}, {'value': '86.5', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2707[B44] 1:16 (N=799,795)', 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000'}, {'value': '82.4', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2707[B44] 1:32 (N=799,795)', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '62.3', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2707[B44] 1:64 (N=799,795)', 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000'}, {'value': '39.4', 'groupId': 'OG001'}]}]}, {'title': '1 month after Vac 3: PMB2707[B44] 1:128(N=799,795)', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before Vaccination 1, 1 month after Vaccination 2, 3', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '814', 'groupId': 'OG000'}, {'value': '812', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'OG001', 'title': 'Group 2: rLP2086 + Saline', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}], 'classes': [{'title': 'Before Vaccination 1: PMB80 [A22] (N=794,799)', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '9.28', 'upperLimit': '9.96'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '9.58', 'upperLimit': '10.33'}]}]}, {'title': '1 month after Vac 2: PMB80 [A22] (N=794,801)', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000', 'lowerLimit': '29.96', 'upperLimit': '33.94'}, {'value': '33.7', 'groupId': 'OG001', 'lowerLimit': '31.69', 'upperLimit': '35.85'}]}]}, {'title': 'Before Vaccination 1: PMB2001 [A56] (N=757,740)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.78', 'upperLimit': '5.32'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.75', 'upperLimit': '5.28'}]}]}, {'title': '1 month after Vac 2: PMB2001 [A56] (N=790,795)', 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '66.17', 'upperLimit': '75.34'}, {'value': '76.3', 'groupId': 'OG001', 'lowerLimit': '71.93', 'upperLimit': '80.99'}]}]}, {'title': '1 month after Vac 3: PMB2001 [A56] (N=796,802)', 'categories': [{'measurements': [{'value': '117.2', 'groupId': 'OG000', 'lowerLimit': '110.14', 'upperLimit': '124.76'}, {'value': '128.2', 'groupId': 'OG001', 'lowerLimit': '120.65', 'upperLimit': '136.27'}]}]}, {'title': 'Before Vaccination 1: PMB2948 [B24] (N=801,793)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '4.23', 'upperLimit': '4.46'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '4.35', 'upperLimit': '4.65'}]}]}, {'title': '1 month after Vac 2: PMB2948 [B24] (N=770,770)', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '13.88', 'upperLimit': '16.15'}, {'value': '16.3', 'groupId': 'OG001', 'lowerLimit': '15.15', 'upperLimit': '17.62'}]}]}, {'title': 'Before Vaccination 1: PMB2707 [B44] (N=806,805)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '4.04', 'upperLimit': '4.15'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '4.10', 'upperLimit': '4.31'}]}]}, {'title': '1 month after Vac 2: PMB2707 [B44] (N=783,776)', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '10.21', 'upperLimit': '12.01'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '10.94', 'upperLimit': '12.96'}]}]}, {'title': '1 month after Vac 3: PMB2707 [B44] (N=799,795)', 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000', 'lowerLimit': '24.99', 'upperLimit': '29.68'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '29.25', 'upperLimit': '34.82'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before Vaccination 1, 1 month after Vaccination 2, 3', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '992', 'groupId': 'OG000'}, {'value': '990', 'groupId': 'OG001'}, {'value': '501', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'OG001', 'title': 'Group 2: rLP2086 + Saline', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'OG002', 'title': 'Group 3: Saline + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}], 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '47.0'}, {'value': '41.7', 'groupId': 'OG001', 'lowerLimit': '38.6', 'upperLimit': '44.9'}, {'value': '49.5', 'groupId': 'OG002', 'lowerLimit': '45.0', 'upperLimit': '54.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Vaccination 1 up to 1 month after Vaccination 3', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'FG001', 'title': 'Group 2: rLP2086 + Saline', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'FG002', 'title': 'Group 3: Saline + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '999'}, {'groupId': 'FG001', 'numSubjects': '998'}, {'groupId': 'FG002', 'numSubjects': '502'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '848'}, {'groupId': 'FG001', 'numSubjects': '841'}, {'groupId': 'FG002', 'numSubjects': '438'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '157'}, {'groupId': 'FG002', 'numSubjects': '64'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'No longer met eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Did not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '999', 'groupId': 'BG000'}, {'value': '998', 'groupId': 'BG001'}, {'value': '502', 'groupId': 'BG002'}, {'value': '2499', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: rLP2086 + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'BG001', 'title': 'Group 2: rLP2086 + Saline', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'BG002', 'title': 'Group 3: Saline + Gardasil', 'description': 'Randomized to receive on a 0, 2-, 6- month schedule'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '11 - less than (<) 15 years', 'categories': [{'measurements': [{'value': '647', 'groupId': 'BG000'}, {'value': '660', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}, {'value': '1650', 'groupId': 'BG003'}]}]}, {'title': '15 - <18 years', 'categories': [{'measurements': [{'value': '352', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}, {'value': '849', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '341', 'groupId': 'BG000'}, {'value': '332', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '843', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '658', 'groupId': 'BG000'}, {'value': '666', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}, {'value': '1656', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2499}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'dispFirstSubmitDate': '2014-07-25', 'completionDateStruct': {'date': '2013-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2011-09-28', 'dispFirstSubmitQcDate': '2014-07-25', 'resultsFirstSubmitDate': '2014-11-21', 'studyFirstSubmitQcDate': '2011-10-26', 'dispFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-21', 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens', 'timeFrame': '1 month after Vaccination 3'}, {'measure': 'Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]', 'timeFrame': '1 month after Vaccination 3'}, {'measure': 'Percentage of Participants With at Least One Adverse Event (AE)', 'timeFrame': 'Vaccination 1 up to 1 month after Vaccination 3'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)', 'timeFrame': '1 month after Vaccination 3'}, {'measure': 'Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants', 'timeFrame': 'Before vaccination 1'}, {'measure': 'Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)', 'timeFrame': 'Before vaccination 1, 1 month after vaccination (Vac) 2, 3'}, {'measure': 'Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level', 'timeFrame': 'Before Vaccination 1, 1 month after Vaccination 2, 3'}, {'measure': 'Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)', 'timeFrame': 'Before Vaccination 1, 1 month after Vaccination 2, 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vaccine', 'rLP2086', 'Gardasil', 'HPV', 'meningitis B', 'N. meningitidis serogroup B', 'adolescents', 'single-blind', 'Meningococcal Vaccines'], 'conditions': ['Vaccines', 'Meningococcal Vaccines']}, 'referencesModule': {'references': [{'pmid': '41276263', 'type': 'DERIVED', 'citation': 'Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.'}, {'pmid': '35164991', 'type': 'DERIVED', 'citation': 'Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.'}, {'pmid': '32681472', 'type': 'DERIVED', 'citation': 'Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent children between the ages of 11 and 17 years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects from 11 to 17 years old at the time of they start the study.\n* Subject must be healthy which will be determined by obtaining subject's medical history, receiving a physical examination and by judgment of the investigator.\n\nExclusion Criteria:\n\n* Previous vaccination with any meningococcal serogroup B vaccine.\n* Previous vaccination with any HPV vaccine.\n* Contraindication to vaccination with Gardasil or any HPV vaccine."}, 'identificationModule': {'nctId': 'NCT01461993', 'briefTitle': 'A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Gardasil (Registered) (Hpv) Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged >=11 To <18 Years', 'orgStudyIdInfo': {'id': 'B1971011'}, 'secondaryIdInfos': [{'id': '6108A1-2007', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'rLP2086 + Gardasil', 'interventionNames': ['Biological: rLP2086 and Gardasil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'rLP2086 and saline', 'interventionNames': ['Biological: rLP2086']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Saline + Gardasil', 'interventionNames': ['Biological: Gardasil']}], 'interventions': [{'name': 'rLP2086 and Gardasil', 'type': 'BIOLOGICAL', 'description': 'Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.', 'armGroupLabels': ['Group 1']}, {'name': 'rLP2086', 'type': 'BIOLOGICAL', 'description': 'Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.', 'armGroupLabels': ['Group 2']}, {'name': 'Gardasil', 'type': 'BIOLOGICAL', 'description': 'Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36526', 'city': 'Daphne', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research Inc.', 'geoPoint': {'lat': 30.60353, 'lon': -87.9036}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': "The Children's Clinic of Jonesboro, PA", 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Pediatric Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Clinical Trials, LLC', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pediatric Care Medical Group', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92557', 'city': 'Moreno Valley', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Health Care - Moreno Valley Pediatrics', 'geoPoint': {'lat': 33.93752, 'lon': -117.23059}}, {'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 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