Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 9:47 AM
Study NCT ID:
NCT01462357
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2011-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510352', 'term': 'human papillomavirus vaccine, L1 type 16, 18'}, {'id': 'D000068857', 'term': 'Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18'}], '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': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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}}, 'adverseEventsModule': {'timeFrame': 'Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).', 'eventGroups': [{'id': 'EG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.', 'otherNumAtRisk': 359, 'deathsNumAtRisk': 359, 'otherNumAffected': 343, 'seriousNumAtRisk': 359, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.', 'otherNumAtRisk': 358, 'deathsNumAtRisk': 358, 'otherNumAffected': 321, 'seriousNumAtRisk': 358, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.', 'otherNumAtRisk': 358, 'deathsNumAtRisk': 358, 'otherNumAffected': 324, 'seriousNumAtRisk': 358, 'deathsNumAffected': 1, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 98, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 119, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 108, 'numAffected': 67}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 370, 'numAffected': 191}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 261, 'numAffected': 135}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 288, 'numAffected': 157}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 374, 'numAffected': 192}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 359, 'numAffected': 199}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 390, 'numAffected': 193}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 69, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 103, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 91, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 241, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 213, 'numAffected': 134}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 232, 'numAffected': 152}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 267, 'numAffected': 166}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 230, 'numAffected': 144}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 254, 'numAffected': 136}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 784, 'numAffected': 329}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 613, 'numAffected': 277}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 669, 'numAffected': 295}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 70, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 71, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 65, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 32, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 288, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 146, 'numAffected': 98}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 200, 'numAffected': 118}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 33, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 34, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 36, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 33, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abortion spontaneous incomplete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epstein-Barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Erythema nodosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Juvenile idiopathic arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mouth cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Syncope', 'stats': 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The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8244.1', 'groupId': 'OG000', 'lowerLimit': '7678.3', 'upperLimit': '8851.7'}, {'value': '5056.0', 'groupId': 'OG001', 'lowerLimit': '4596.5', 'upperLimit': '5561.5'}, {'value': '4807.4', 'groupId': 'OG002', 'lowerLimit': '4420.8', 'upperLimit': '5227.7'}]}]}, {'title': 'Anti-HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5277.4', 'groupId': 'OG000', 'lowerLimit': '4858.6', 'upperLimit': '5732.4'}, {'value': '1207.2', 'groupId': 'OG001', 'lowerLimit': '1092.9', 'upperLimit': '1333.4'}, {'value': '1653.5', 'groupId': 'OG002', 'lowerLimit': '1484.4', 'upperLimit': '1841.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.69', 'groupDescription': 'Immune response to anti-HPV-16 in terms of Geometric Mean Titers (GMT): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% CI for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.26', 'groupDescription': 'Immune response to anti-HPV-18 in terms of GMT: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 7 (i.e. one month after the last dose of study vaccine)', 'description': 'Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.'}, {'type': 'PRIMARY', 'title': 'Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-HPV-16', 'categories': [{'measurements': [{'value': '8256.4', 'groupId': 'OG000', 'lowerLimit': '7650.3', 'upperLimit': '8910.6'}, {'value': '4886.1', 'groupId': 'OG001', 'lowerLimit': '4435.4', 'upperLimit': '5382.6'}, {'value': '4789.2', 'groupId': 'OG002', 'lowerLimit': '4409.6', 'upperLimit': '5201.4'}]}]}, {'title': 'Anti-HPV-18', 'categories': [{'measurements': [{'value': '5267.8', 'groupId': 'OG000', 'lowerLimit': '4857.1', 'upperLimit': '5713.2'}, {'value': '1166.3', 'groupId': 'OG001', 'lowerLimit': '1056', 'upperLimit': '1288.2'}, {'value': '1635.8', 'groupId': 'OG002', 'lowerLimit': '1470', 'upperLimit': '1820.4'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.52', 'ciLowerLimit': '3.97', 'ciUpperLimit': '5.13', 'groupDescription': 'Anti-HPV-18 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-18 antibodies.'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '1.49', 'ciUpperLimit': '1.91', 'groupDescription': 'Anti-HPV-16 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-16 antibodies.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 7 (i.e. one month after the last dose of study vaccine)', 'description': 'Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC which included all subjects, regardless of serostatus, who received at least one dose of vaccine in this study and for whom data were available at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-HPV-16, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-16, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '316', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '319', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '319', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-16, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '316', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-16, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '307', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '314', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '307', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-16, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0 and Months 12, 18, 24 and 36', 'description': 'Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥ 19 and 18 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Month 36 ATP cohort for immunogenicity, which included subjects who returned for blood sampling at Month 36, for whom data concerning immunogenicity outcome measures were available at the specified time points and who were seronegative before vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-HPV-16/18 Antibody Titers as Assessed by ELISA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-HPV-16, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '9.5'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '9.5'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '9.5', 'upperLimit': '9.5'}]}]}, {'title': 'Anti-HPV-18, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '9.0'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '9.0'}, {'value': '9.0', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '9.0'}]}]}, {'title': 'Anti-HPV-16, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2209.2', 'groupId': 'OG000', 'lowerLimit': '2014', 'upperLimit': '2423.4'}, {'value': '1294.8', 'groupId': 'OG001', 'lowerLimit': '1160.4', 'upperLimit': '1444.9'}, {'value': '1600.7', 'groupId': 'OG002', 'lowerLimit': '1457.3', 'upperLimit': '1758.2'}]}]}, {'title': 'Anti-HPV-18, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '319', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1299.3', 'groupId': 'OG000', 'lowerLimit': '1176.2', 'upperLimit': '1435.6'}, {'value': '266.6', 'groupId': 'OG001', 'lowerLimit': '236.3', 'upperLimit': '300.8'}, {'value': '478.5', 'groupId': 'OG002', 'lowerLimit': '422.8', 'upperLimit': '541.6'}]}]}, {'title': 'Anti-HPV-16, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1488.8', 'groupId': 'OG000', 'lowerLimit': '1365.5', 'upperLimit': '1623.3'}, {'value': '684.4', 'groupId': 'OG001', 'lowerLimit': '605.8', 'upperLimit': '773.2'}, {'value': '824.0', 'groupId': 'OG002', 'lowerLimit': '744.4', 'upperLimit': '912.2'}]}]}, {'title': 'Anti-HPV-18, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '754.2', 'groupId': 'OG000', 'lowerLimit': '682.6', 'upperLimit': '833.2'}, {'value': '134.8', 'groupId': 'OG001', 'lowerLimit': '118.1', 'upperLimit': '154'}, {'value': '231.3', 'groupId': 'OG002', 'lowerLimit': '202.4', 'upperLimit': '264.4'}]}]}, {'title': 'Anti-HPV-16, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '307', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1285.0', 'groupId': 'OG000', 'lowerLimit': '1181.1', 'upperLimit': '1398.0'}, {'value': '514.1', 'groupId': 'OG001', 'lowerLimit': '455.4', 'upperLimit': '580.3'}, {'value': '637.1', 'groupId': 'OG002', 'lowerLimit': '575.8', 'upperLimit': '704.9'}]}]}, {'title': 'Anti-HPV-18, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '613.7', 'groupId': 'OG000', 'lowerLimit': '555.0', 'upperLimit': '678.6'}, {'value': '106.3', 'groupId': 'OG001', 'lowerLimit': '93.2', 'upperLimit': '121.3'}, {'value': '182.0', 'groupId': 'OG002', 'lowerLimit': '159.3', 'upperLimit': '208.0'}]}]}, {'title': 'Anti-HPV-16, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1061.4', 'groupId': 'OG000', 'lowerLimit': '971.8', 'upperLimit': '1159.4'}, {'value': '379.8', 'groupId': 'OG001', 'lowerLimit': '333.4', 'upperLimit': '432.7'}, {'value': '472.4', 'groupId': 'OG002', 'lowerLimit': '425', 'upperLimit': '525.0'}]}]}, {'title': 'Anti-HPV-18, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '486.5', 'groupId': 'OG000', 'lowerLimit': '437.8', 'upperLimit': '540.6'}, {'value': '71.0', 'groupId': 'OG001', 'lowerLimit': '62.0', 'upperLimit': '81.2'}, {'value': '119.1', 'groupId': 'OG002', 'lowerLimit': '103.4', 'upperLimit': '137.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 and Months 12, 18, 24 and 36', 'description': 'Anti-HPV 16/18 antibody titers were presented as GMTs and expressed in EL.U/mL based on ELISA.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Month 36 ATP cohort for immunogenicity, which included subjects who returned for blood sampling at Month 36, for whom data concerning immunogenicity outcome measures were available at the specified time points and who were seronegative before vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '174.0', 'groupId': 'OG000', 'lowerLimit': '159.3', 'upperLimit': '190.1'}, {'value': '62.3', 'groupId': 'OG001', 'lowerLimit': '54.7', 'upperLimit': '71.0'}, {'value': '77.4', 'groupId': 'OG002', 'lowerLimit': '69.6', 'upperLimit': '86.0'}]}]}, {'title': 'Anti-HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000', 'lowerLimit': '76.7', 'upperLimit': '94.8'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '14.3'}, {'value': '20.9', 'groupId': 'OG002', 'lowerLimit': '18.2', 'upperLimit': '24.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 36', 'description': 'Data at Month 36 were also expressed as International Units per milliliter (IU/mL). Conversion factor from EU/mL to IU/mL was determined to be 1/6.1 for HPV-16 and 1/5.7 for HPV-18, using the WHO International Standards (NIBSC codes 05-134 and 10-140 for HPV-16 and HPV-18, respectively). The assay cut-offs were therefore 3.1 IU/mL and 3.2 IU/mL for anti-HPV-16 and anti-HPV-18 antibodies, respectively.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Month 36 ATP cohort for immunogenicity, which included subjects who returned for blood sampling at Month 36, for whom data concerning immunogenicity outcome measures were available at the specified time point and who were seronegative before vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-HPV-16, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-16, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-16, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-16, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-16, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-16, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HPV-18, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0 and Months 7, 12, 18, 24 and 36', 'description': 'Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥40 ED50) in the serum of subjects seronegative before vaccination. The assay was performed on a subset of approximately 100 subjects per study group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a subset of approximately 100 subjects per study group, who returned for blood sampling at Month 36, for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-HPV-16, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'Anti-HPV-18, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'Anti-HPV-16, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52868.5', 'groupId': 'OG000', 'lowerLimit': '44171.0', 'upperLimit': '63278.5'}, {'value': '19130.1', 'groupId': 'OG001', 'lowerLimit': '15166.8', 'upperLimit': '24129.0'}, {'value': '22182.7', 'groupId': 'OG002', 'lowerLimit': '17611.7', 'upperLimit': '27940.1'}]}]}, {'title': 'Anti-HPV-18, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24068.5', 'groupId': 'OG000', 'lowerLimit': '19293.2', 'upperLimit': '30025.8'}, {'value': '4726.5', 'groupId': 'OG001', 'lowerLimit': '3600.9', 'upperLimit': '6204.0'}, {'value': '8243.9', 'groupId': 'OG002', 'lowerLimit': '6276.2', 'upperLimit': '10828.4'}]}]}, {'title': 'Anti-HPV-16, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10695.9', 'groupId': 'OG000', 'lowerLimit': '8564.9', 'upperLimit': '13357.1'}, {'value': '4280.1', 'groupId': 'OG001', 'lowerLimit': '3245.9', 'upperLimit': '5643.6'}, {'value': '5843.8', 'groupId': 'OG002', 'lowerLimit': '4599.8', 'upperLimit': '7424.1'}]}]}, {'title': 'Anti-HPV-18, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3683.3', 'groupId': 'OG000', 'lowerLimit': '2914.4', 'upperLimit': '4655.2'}, {'value': '689.0', 'groupId': 'OG001', 'lowerLimit': '517.2', 'upperLimit': '917.8'}, {'value': '1788.6', 'groupId': 'OG002', 'lowerLimit': '1308.6', 'upperLimit': '2444.7'}]}]}, {'title': 'Anti-HPV-16, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8436.3', 'groupId': 'OG000', 'lowerLimit': '6650.6', 'upperLimit': '10701.4'}, {'value': '2129.7', 'groupId': 'OG001', 'lowerLimit': '1512.8', 'upperLimit': '2998.1'}, {'value': '2987.2', 'groupId': 'OG002', 'lowerLimit': '2218.5', 'upperLimit': '4022.3'}]}]}, {'title': 'Anti-HPV-18, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2426.3', 'groupId': 'OG000', 'lowerLimit': '1885.7', 'upperLimit': '3121.7'}, {'value': '295.7', 'groupId': 'OG001', 'lowerLimit': '217.0', 'upperLimit': '402.8'}, {'value': '812.1', 'groupId': 'OG002', 'lowerLimit': '577.0', 'upperLimit': '1143.0'}]}]}, {'title': 'Anti-HPV-16, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5036.7', 'groupId': 'OG000', 'lowerLimit': '4097.8', 'upperLimit': '6190.7'}, {'value': '1211.8', 'groupId': 'OG001', 'lowerLimit': '893.8', 'upperLimit': '1642.9'}, {'value': '1967.2', 'groupId': 'OG002', 'lowerLimit': '1507.5', 'upperLimit': '2567.2'}]}]}, {'title': 'Anti-HPV-18, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1763.0', 'groupId': 'OG000', 'lowerLimit': '1384.5', 'upperLimit': '2245.0'}, {'value': '237.1', 'groupId': 'OG001', 'lowerLimit': '177.2', 'upperLimit': '317.1'}, {'value': '573.1', 'groupId': 'OG002', 'lowerLimit': '421.5', 'upperLimit': '779.3'}]}]}, {'title': 'Anti-HPV-16, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4357.8', 'groupId': 'OG000', 'lowerLimit': '3577.8', 'upperLimit': '5307.9'}, {'value': '1128.9', 'groupId': 'OG001', 'lowerLimit': '857.4', 'upperLimit': '1486.4'}, {'value': '1577.0', 'groupId': 'OG002', 'lowerLimit': '1210.4', 'upperLimit': '2054.5'}]}]}, {'title': 'Anti-HPV-18, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1613.9', 'groupId': 'OG000', 'lowerLimit': '1267.6', 'upperLimit': '2054.7'}, {'value': '185.8', 'groupId': 'OG001', 'lowerLimit': '140.4', 'upperLimit': 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Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '350', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '350', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC, which included all subjects with at least one study vaccine administered and who had their symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Any Arthralgia - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Any Arthralgia - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Any Arthralgia - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Any Arthralgia - 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Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Related Rash - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Related Rash - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature ( ≥ 37.5°C) - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature ( ≥ 37.5°C) - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature ( ≥ 37.5°C) - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature ( ≥ 37.5°C) - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature ( > 39.0°C) - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature ( > 39.0°C) - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature ( > 39.0°C) - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature ( > 39.0°C) - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Any Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Any Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Any Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Any Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Related Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Related Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Related Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (\\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC, which included all subjects with at least one study vaccine administered and who had their symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Subjects with any AE(s)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with any Grade 3 AE(s)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with any Related AE(s)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 12', 'description': 'pIMDs were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Medically Significant Conditions (MSCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period)', 'description': 'MSCs were defined as AEs prompting emergency room (ER) or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period)', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With SAEs Related to the Investigational Product, to Study Participation, to GSK Concomitant Products or Any Fatal SAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Related SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fatal SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period)', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related = an event assessed by the investigator as causally related to the investigational product, to study participation or to GSK concomitant products.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Live infant NO ACA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Live infant CA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Elective termination NO ACA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Elective termination CA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ectopic pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Spontaneous abortion NO ACA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Stillbirth NO ACA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Stillbirth CA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lost to follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pregnancy ongoing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period)', 'description': 'Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant congenital anomaly (CA), Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Using a Concomitant Medication Throughout the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Any, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}]}, {'title': 'Any antipyretic, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Prophylactic antipyretic, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any antibiotic, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Prophylactic antibiotic, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Any antipyretic, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Prophylactic antipyretic, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any antibiotic, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Prophylactic antibiotic, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Any antipyretic, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Prophylactic antipyretic, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any antibiotic, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Prophylactic antibiotic, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}]}, {'title': 'Any antipyretic, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Prophylactic antipyretic, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any antibiotic, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Prophylactic antibiotic, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period) following vaccination after each dose and across doses', 'description': 'The number of subjects who have used any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Completing the Vaccination Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '346', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period)', 'description': 'The number of subjects who have completed the three-dose vaccination schedule in all groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'FG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'FG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '359'}, {'groupId': 'FG001', 'numSubjects': '358'}, {'groupId': 'FG002', 'numSubjects': '358'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '351'}, {'groupId': 'FG001', 'numSubjects': '339'}, {'groupId': 'FG002', 'numSubjects': '346'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': '1079 subjects entered this study, of which 4 subjects signed an informed consent but did not receive a single dose of the vaccine and were hence not counted as starting the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}, {'value': '1075', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervarix 2 Dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'BG001', 'title': 'Gardasil 2 Dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'BG002', 'title': 'Gardasil 3 Dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '1.64', 'groupId': 'BG000'}, {'value': '11.5', 'spread': '1.56', 'groupId': 'BG001'}, {'value': '11.6', 'spread': '1.64', 'groupId': 'BG002'}, {'value': '11.53', 'spread': '1.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '359', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}, {'value': '1075', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African Heritage / African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Asian - Central / South Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '536', 'groupId': 'BG003'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}]}, {'title': 'White - Arabic / North African Heritage', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'White - Caucasian / European Heritage', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '258', 'groupId': 'BG003'}]}]}, {'title': 'White - Caucasian / African Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'African - White / Caucasian Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1079}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2015-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2011-10-27', 'resultsFirstSubmitDate': '2014-08-11', 'studyFirstSubmitQcDate': '2011-10-27', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-25', 'studyFirstPostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity', 'timeFrame': 'At Month 7 (i.e. one month after the last dose of study vaccine)', 'description': 'Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to (≥) 19 and 18 ELISA units per milliliter (EL.U/mL), respectively), in the serum of subjects seronegative before vaccination.'}, {'measure': 'Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity', 'timeFrame': 'At Month 7 (i.e. one month after the last dose of study vaccine)', 'description': 'Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.'}, {'measure': 'Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC)', 'timeFrame': 'At Month 7 (i.e. one month after the last dose of study vaccine)', 'description': 'Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.'}], 'secondaryOutcomes': [{'measure': 'Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA', 'timeFrame': 'At Day 0 and Months 12, 18, 24 and 36', 'description': 'Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥ 19 and 18 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination.'}, {'measure': 'Anti-HPV-16/18 Antibody Titers as Assessed by ELISA', 'timeFrame': 'At Day 0 and Months 12, 18, 24 and 36', 'description': 'Anti-HPV 16/18 antibody titers were presented as GMTs and expressed in EL.U/mL based on ELISA.'}, {'measure': 'Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 36', 'timeFrame': 'At Month 36', 'description': 'Data at Month 36 were also expressed as International Units per milliliter (IU/mL). Conversion factor from EU/mL to IU/mL was determined to be 1/6.1 for HPV-16 and 1/5.7 for HPV-18, using the WHO International Standards (NIBSC codes 05-134 and 10-140 for HPV-16 and HPV-18, respectively). The assay cut-offs were therefore 3.1 IU/mL and 3.2 IU/mL for anti-HPV-16 and anti-HPV-18 antibodies, respectively.'}, {'measure': 'Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity', 'timeFrame': 'At Day 0 and Months 7, 12, 18, 24 and 36', 'description': 'Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥40 ED50) in the serum of subjects seronegative before vaccination. The assay was performed on a subset of approximately 100 subjects per study group.'}, {'measure': 'Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity', 'timeFrame': 'At Day 0 and Months 7, 12, 18, 24 and 36', 'description': 'Anti-HPV 16/18 antibody titers were presented as GMT and expressed in titers using the PBNA. The assay was performed on a subset of approximately 100 subjects per study group.'}, {'measure': 'Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC', 'timeFrame': 'At Day 0 and Months 7, 12, 18, 24 and 36', 'description': 'Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥40 ED50) in the serum of subjects seronegative before vaccination. The assay was performed on a subset of approximately 100 subjects per study group.'}, {'measure': 'Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC', 'timeFrame': 'At Day 0 and Months 7, 12, 18, 24 and 36', 'description': 'Anti-HPV 16/18 antibody titers were presented as GMT and expressed in titers using the PBNA. The assay was performed on a subset of approximately 100 subjects per study group.'}, {'measure': 'T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)', 'timeFrame': 'At Day 0 and Months 7, 12, 24 and 36', 'description': 'Among immune markers expressed were Interleukin-2 (IL-2), Interferon-gamma (IFN-γ), Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L). The assay was performed on a sub-cohort of approximately 100 subjects per study group.'}, {'measure': 'B-cell-mediated Immune Responses in the Sub-cohort for CMI', 'timeFrame': 'At Day 0 and Months 7, 12, 24 and 36', 'description': 'The frequency of B-cell Elispot response to HPV-16/18 by overall status was presented. The assay was performed on a sub-cohort of approximately 100 subjects per study group.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (\\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)', 'timeFrame': 'From Day 0 up to Month 12', 'description': 'pIMDs were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.'}, {'measure': 'Number of Subjects With Medically Significant Conditions (MSCs)', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period)', 'description': 'MSCs were defined as AEs prompting emergency room (ER) or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period)', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.'}, {'measure': 'Number of Subjects With SAEs Related to the Investigational Product, to Study Participation, to GSK Concomitant Products or Any Fatal SAE', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period)', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related = an event assessed by the investigator as causally related to the investigational product, to study participation or to GSK concomitant products.'}, {'measure': 'Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period)', 'description': 'Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant congenital anomaly (CA), Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.'}, {'measure': 'Number of Subjects Using a Concomitant Medication Throughout the Study Period', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period) following vaccination after each dose and across doses', 'description': 'The number of subjects who have used any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.'}, {'measure': 'Number of Subjects Completing the Vaccination Schedule', 'timeFrame': 'From Day 0 up to Month 36 (throughout the study period)', 'description': 'The number of subjects who have completed the three-dose vaccination schedule in all groups.'}]}, 'conditionsModule': {'keywords': ['Human papillomavirus', 'Safety', 'HPV vaccine', 'Immune response'], 'conditions': ['Infections, Papillomavirus']}, 'referencesModule': {'availIpds': [{'id': '115411', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115411', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115411', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115411', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115411', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115411', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '26062002', 'type': 'BACKGROUND', 'citation': 'Leung TF, Liu AP, Lim FS, Thollot F, Oh HM, Lee BW, Rombo L, Tan NC, Rouzier R, Friel D, De Muynck B, De Simoni S, Suryakiran P, Hezareh M, Folschweiller N, Thomas F, Struyf F. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial. Hum Vaccin Immunother. 2015;11(7):1689-702. doi: 10.1080/21645515.2015.1050570.'}, {'pmid': '29174109', 'type': 'BACKGROUND', 'citation': 'Leung TF, Liu AP, Lim FS, Thollot F, Oh HML, Lee BW, Rombo L, Tan NC, Rouzier R, De Simoni S, Suryakiran P, Hezareh M, Thomas F, Folschweiller N, Struyf F. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and 4vHPV vaccine administered according to two- or three-dose schedules in girls aged 9-14 years: Results to month 36 from a randomized trial. Vaccine. 2018 Jan 2;36(1):98-106. doi: 10.1016/j.vaccine.2017.11.034. Epub 2017 Nov 23.'}, {'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.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes can and will comply with the requirements of the protocol and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) (LAR\\[s\\]) can and will comply with the requirements of the protocol.\n* A female between, and including, 9 and 14 years of age at the time of the first vaccination.\n* Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, if capable, the subject should sign and personally date a written informed assent.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Female subjects of non-childbearing potential may be enrolled in the study.\n* Female subjects of childbearing potential may be enrolled in the study, if the subject:\n\n * has practiced adequate contraception for 30 days prior to vaccination, and\n * has a negative pregnancy test on the day of vaccination, and\n * has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.\n* Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than those foreseen in the protocol.\n* Child in care.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 36).\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.\n* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.\n* Cancer or autoimmune disease under treatment.\n* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).\n* Previous administration of vaccine components.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Family history of congenital or hereditary immunodeficiency.\n* Major congenital defects or serious chronic illness.\n* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.\n* Acute disease and/or fever at the time of enrolment.\n* Drug and/or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT01462357', 'briefTitle': "Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females", 'orgStudyIdInfo': {'id': '115411'}, 'secondaryIdInfos': [{'id': '2011-002035-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervarix 2 dose Group', 'description': 'Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.', 'interventionNames': ['Biological: Cervarix', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Gardasil 2 dose Group', 'description': 'Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.', 'interventionNames': ['Biological: Gardasil', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Gardasil 3 dose Group', 'description': 'Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.', 'interventionNames': ['Biological: Gardasil']}], 'interventions': [{'name': 'Cervarix', 'type': 'BIOLOGICAL', 'description': '2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6.', 'armGroupLabels': ['Cervarix 2 dose Group']}, {'name': 'Gardasil', 'type': 'BIOLOGICAL', 'description': '2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gardasil 2 dose Group) or at Day 0, Month 2 and Month 6 (Gardasil 3 dose Group), respectively.', 'armGroupLabels': ['Gardasil 2 dose Group', 'Gardasil 3 dose Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 2 to maintain blinding.', 'armGroupLabels': ['Cervarix 2 dose Group', 'Gardasil 2 dose Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100', 'city': 'Dax', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'zip': '83300', 'city': 'Draguignan', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.53692, 'lon': 6.46458}}, {'zip': '54270', 'city': 'Essey-lès-Nancy', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.705, 'lon': 6.22691}}, {'zip': '76620', 'city': 'Le Havre', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'zip': '06300', 'city': 'Nice', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '19300', 'city': "Rosiers-d'Égletons", 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.37738, 'lon': 2.00813}}, {'zip': '37540', 'city': 'Saint Cyr Sur Loir', 'country': 'France', 'facility': 'GSK Investigational Site'}, {'zip': '31600', 'city': 'Seysses', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.49801, 'lon': 1.31081}}, {'zip': '37100', 'city': 'Tours', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Pokfulam', 'country': 'Hong Kong', 'facility': 'GSK Investigational Site'}, {'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '228510', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '229899', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '768826', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': 'SE-631 88', 'city': 'Eskilstuna', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.36661, 'lon': 16.5077}}, {'zip': 'SE-581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': 'SE-701 16', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com/Posting.aspx?ID=4513', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below).', 'ipdSharing': 'YES', 'description': 'IPD is available via the Clinical Study Data Request site (click on the link provided below).', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}