Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT00092534
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2004-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D003218', 'term': 'Condylomata Acuminata'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'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': 'D014860', 'term': 'Warts'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068857', 'term': 'Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}], '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'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Executive Vice President, Clinical and Quantitative Sciences', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From randomization in the Base Study to up to 10 years after completion of the Base Study (up to 14 years)', 'description': 'The number of participants at risk includes randomized participants who had follow-up data available. Both serious adverse events (SAEs) and nonserious AEs were collected in the Base Study. Safety data for the LTFU were evaluated based on health outcomes data available from the national registries; in addition, AEs and SAEs associated with blood draws at LTFU Year 5 and Year 10 were also collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Base Study Group 1: qHPV Vaccine', 'description': 'During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) during the Vaccination Period and were followed for up to 4 years during the Base Study Follow-Up.', 'otherNumAtRisk': 6082, 'deathsNumAtRisk': 6082, 'otherNumAffected': 551, 'seriousNumAtRisk': 6082, 'deathsNumAffected': 7, 'seriousNumAffected': 46}, {'id': 'EG001', 'title': 'Base Study Group 2: Placebo', 'description': 'Participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) during the Base Study Vaccination Period, and then received 3 qHPV vaccinations during the 4-year Base Study EXT.', 'otherNumAtRisk': 6075, 'deathsNumAtRisk': 6075, 'otherNumAffected': 499, 'seriousNumAtRisk': 6075, 'deathsNumAffected': 5, 'seriousNumAffected': 56}, {'id': 'EG002', 'title': 'Base Study EXT', 'description': 'Participants who received placebo (N=581) or an incomplete qHPV vaccine regimen (N=13) were enrolled to receive qHPV vaccine during the base study extension; participants designated as "Not Completed" are those who did not complete all three vaccinations and/or all required follow-up visits.', 'otherNumAtRisk': 594, 'deathsNumAtRisk': 594, 'otherNumAffected': 0, 'seriousNumAtRisk': 594, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.', 'otherNumAtRisk': 2448, 'deathsNumAtRisk': 2448, 'otherNumAffected': 0, 'seriousNumAtRisk': 2448, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'LTFU: Cohort 2', 'description': 'Participants who received placebo in the Base Study and qHPV vaccine after completion of the Base Study and prior to entry into the LTFU. Cohort 2 provided a total of approximately 10 years of follow-up post-vaccination in the LTFU.', 'otherNumAtRisk': 1888, 'deathsNumAtRisk': 1888, 'otherNumAffected': 0, 'seriousNumAtRisk': 1888, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 120}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 503}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 433}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 76}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 167}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cervicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Endometritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infective thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pelvic Inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Typhoid fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Uterine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chemical poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Failed forceps delivery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abortion threatened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Breech presentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Brow presentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cephalo-pelvic disproportion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cervix dystocia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 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0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cervical incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site joint movement impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6082, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6075, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 594, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2448, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1888, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5306', 'groupId': 'OG000'}, {'value': '5262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Base Study Group 1: qHPV Vaccine', 'description': 'During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}, {'id': 'OG001', 'title': 'Base Study Group 2: Placebo', 'description': 'During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent relative risk reduction', 'ciPctValue': '95', 'paramValue': '96.6', 'ciLowerLimit': '88.2', 'ciUpperLimit': '99.6', 'estimateComment': 'Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years', 'description': 'This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine consensus diagnosis of CIN 2 or worse up to 4 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, adenocarcinoma in situ (AIS) or cervical cancer related to HPV 16 or 18.', 'unitOfMeasure': 'Incidence per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received 3 qHPV doses in 1 year, had no protocol violations that could affect evaluation of vaccine efficacy, were polymerase chain reaction (PCR)-negative and seronegative based on competitive Luminex immunoassay (cLIA) to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7, and had data available.'}, {'type': 'PRIMARY', 'title': 'Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 years since Vaccine Dose 1', 'description': 'This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine Nordic pathology panel (NPP) consensus diagnosis of CIN 2 or worse up to 14 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to HPV 16 or 18. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'Incidence per 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who received 3 qHPV vaccine doses in 1 year, had no protocol violations that could affect evaluation of efficacy, had been PCR-negative and seronegative based on cLIA at Day 1 and PCR-negative through Month 7 of the Base Study to the relevant HPV type(s), and had LTFU data available.'}, {'type': 'PRIMARY', 'title': 'Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study', 'timeFrame': 'up to 22 years post Vaccination Dose 1', 'description': 'This measure is defined to have occurred when, on a single cervical biopsy, ECC, LEEP, or conization specimen, there was HPV Vaccine NPP consensus diagnosis of CIN 2 or worse up to 22 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to HPV 16 or 18. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU will be included.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-11'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Human Papillomavirus (HPV) 6 Titer ≥20 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1056', 'groupId': 'OG000'}, {'value': '1057', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Base Study Group 1: qHPV Vaccine', 'description': 'During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}, {'id': 'OG001', 'title': 'Base Study Group 2: Placebo', 'description': 'During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '1054', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7 (4 weeks after Vaccination 3)', 'description': 'Anti-HPV levels \\>20 mMU/mL neutralize a large input load of HPV 6 pseudovirions in vitro; thus, the number of participants with anti-HPV 6 ≥20 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Human Papillomavirus (HPV) 11 Titer ≥16 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}, {'value': '1057', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Base Study Group 1: qHPV Vaccine', 'description': 'During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}, {'id': 'OG001', 'title': 'Base Study Group 2: Placebo', 'description': 'During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '1054', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Anti-HPV levels \\>20 mMU/mL neutralize a large input load of HPV 11 virions in vitro; thus, the number of participants with anti-HPV 11 ≥16 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Human Papillomavirus (HPV) 16 Titer ≥20 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1017', 'groupId': 'OG000'}, {'value': '994', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Base Study Group 1: qHPV Vaccine', 'description': 'During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}, {'id': 'OG001', 'title': 'Base Study Group 2: Placebo', 'description': 'During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '1014', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Anti-HPV levels \\>20 mMU/mL neutralize a large input load of HPV 16 pseudovirions in vitro; thus, the number of participants with anti-HPV 16 ≥20 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Human Papillomavirus (HPV) 18 Titer ≥24 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1140', 'groupId': 'OG000'}, {'value': '1119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Base Study Group 1: qHPV Vaccine', 'description': 'During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}, {'id': 'OG001', 'title': 'Base Study Group 2: Placebo', 'description': 'During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '1133', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Anti-HPV levels \\>20 mMU/mL neutralize a large input load of HPV 18 pseudovirions in vitro; thus, the number of participants with anti-HPV 18 ≥24 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.'}, {'type': 'SECONDARY', 'title': 'Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 31/33/35/39/45/51/52/56/58/59-related Cervical Intraepithelial Neoplasia (CIN) Grade 2 or Worse in the Long-term Follow-up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2355', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 years since Vaccination Dose 1', 'description': 'This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine Nordic pathology panel (NPP) consensus diagnosis of CIN 2 or worse related to nonvaccine HPV types up to 14 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to nonvaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, or 59. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'Incidence per 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who had received ≥1 qHPV vaccination, had any follow up visit in the LTFU, and had been PCR-negative and seronegative based on cLIA to the appropriate HPV type(s) at Day 1.'}, {'type': 'SECONDARY', 'title': 'Incidence of the Composite Endpoint of HPV 6/11/16/18-related CIN (Any Grade), AIS, Cervical Cancer, Vulvar Cancer or Vaginal Cancer the Long-term Follow-up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2312', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 years since Vaccination Dose 1', 'description': 'This measure was defined to have occurred if on a single biopsy or excised tissue, there was the NPP consensus diagnosis of CIN 1, CIN 2, CIN 3, AIS, cervical cancer, vulvar cancer or vaginal cancer AND at least 1 of HPV types 6, 11, 16 or 18 was detected by Thin-section PCR in an adjacent section from the same tissue block. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'Incidence per 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who received 3 qHPV vaccine doses in 1 year, had no protocol violations that could affect efficacy, had been PCR-negative and seronegative based on cLIA at Day 1 and PCR-negative through Month 7 of the Base Study to relevant HPV type(s), and had LTFU data available.'}, {'type': 'SECONDARY', 'title': 'Incidence of the Composite Endpoint of HPV 6/11/16/18-related CIN (Any Grade), AIS, Cervical Cancer, Vulvar Cancer or Vaginal Cancer the Long-term Follow-up (LTFU) Study', 'timeFrame': 'up to 22 years since Vaccination Dose 1', 'description': 'This measure is defined to have occurred if on a single biopsy or excised tissue, there is the NPP consensus diagnosis of CIN 1, CIN 2, CIN 3, AIS, cervical cancer, vulvar cancer or vaginal cancer AND at least 1 of HPV types 6, 11, 16 or 18 is detected by Thin-section PCR in an adjacent section from the same tissue block.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-11'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'title': 'Anti-HPV 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.2', 'groupId': 'OG000', 'lowerLimit': '84.7', 'upperLimit': '94.0'}]}]}, {'title': 'Anti-HPV 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.2', 'groupId': 'OG000', 'lowerLimit': '80.7', 'upperLimit': '90.0'}]}]}, {'title': 'Anti-HPV 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '348.6', 'groupId': 'OG000', 'lowerLimit': '328.3', 'upperLimit': '370.2'}]}]}, {'title': 'Anti-HPV 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1332', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000', 'lowerLimit': '30.2', 'upperLimit': '34.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 108 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using cLIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who received 3 qHPV vaccine doses in 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'title': 'Anti-HPV 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '73.8', 'upperLimit': '83.2'}]}]}, {'title': 'Anti-HPV 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000', 'lowerLimit': '62.6', 'upperLimit': '71.3'}]}]}, {'title': 'Anti-HPV 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1005', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '291.2', 'groupId': 'OG000', 'lowerLimit': '272.1', 'upperLimit': '311.5'}]}]}, {'title': 'Anti-HPV 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '28.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 168 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using cLIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'title': 'Anti-HPV 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': '95.6'}]}]}, {'title': 'Anti-HPV 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '94.1', 'upperLimit': '96.6'}]}]}, {'title': 'Anti-HPV 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '99.5'}]}]}, {'title': 'Anti-HPV 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1332', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000', 'lowerLimit': '57.2', 'upperLimit': '62.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 108 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using cLIA. Seropositivity was assessed by competitive Luminex Immunoassay (cLIA); the serostatus cut-offs for anti-HPV 6, 11, 16 and 18 serum cLIA were 20, 16, 20 and 24 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'title': 'Anti-HPV 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '92.3'}]}]}, {'title': 'Anti-HPV 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '89.2', 'upperLimit': '92.8'}]}]}, {'title': 'Anti-HPV 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1005', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '99.0'}]}]}, {'title': 'Anti-HPV 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '55.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 168 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using cLIA. Seropositivity was assessed by cLIA; the serostatus cut-offs for anti-HPV 6, 11, 16 and 18 serum cLIA were 20, 16, 20 and 24 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'title': 'Anti-HPV 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1235', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '90.5', 'upperLimit': '100.1'}]}]}, {'title': 'Anti-HPV 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1235', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '64.3', 'upperLimit': '70.8'}]}]}, {'title': 'Anti-HPV 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '346.1', 'groupId': 'OG000', 'lowerLimit': '327.3', 'upperLimit': '365.9'}]}]}, {'title': 'Anti-HPV 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1333', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.1', 'groupId': 'OG000', 'lowerLimit': '43.3', 'upperLimit': '49.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 108 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using IgG LIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'title': 'Anti-HPV 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1054', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000', 'lowerLimit': '76.1', 'upperLimit': '86.5'}]}]}, {'title': 'Anti-HPV 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '50.2', 'upperLimit': '57.0'}]}]}, {'title': 'Anti-HPV 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '290.2', 'groupId': 'OG000', 'lowerLimit': '271.0', 'upperLimit': '310.8'}]}]}, {'title': 'Anti-HPV 18310.8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1036', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000', 'lowerLimit': '33.7', 'upperLimit': '39.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 168 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using IgG LIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'title': 'Anti-HPV 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1235', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '98.4'}]}]}, {'title': 'Anti-HPV 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1235', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '97.3'}]}]}, {'title': 'Anti-HPV 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.7', 'upperLimit': '100.0'}]}]}, {'title': 'Anti-HPV 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1333', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '92.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 108 months since Vaccination Dose 1', 'description': 'Antibodies to HPV types were measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 at Month 108 were 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}], 'classes': [{'title': 'Anti-HPV 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1054', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '98.8'}]}]}, {'title': 'Anti-HPV 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '98.8'}]}]}, {'title': 'Anti-HPV 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1000', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.6', 'upperLimit': '100.0'}]}]}, {'title': 'Anti-HPV 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1036', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '92.2', 'upperLimit': '95.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 168 months since Vaccination Dose 1', 'description': 'Antibodies to HPV types were measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 at Month 168 were 9, 6, 5, and 5 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 216 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 216 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types will be measured using IgG LIA..', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-11'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 216 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) ) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 216 months since Vaccination Dose 1', 'description': 'Antibodies to HPV types will be measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 are 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. The percentage of participants that are seropositive for each type will be summarized.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-11'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 264 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 264 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types will be measured using IgG LIA..', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-11'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 264 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 264 months since Vaccination Dose 1', 'description': 'Antibodies to HPV types will be measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 are 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. The percentage of participants that are seropositive for each type will be summarized.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-11'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Base Study Group 1: qHPV Vaccine', 'description': 'During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}, {'id': 'FG001', 'title': 'Base Study Group 2: Placebo', 'description': 'During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}, {'id': 'FG002', 'title': 'Base Study EXT', 'description': 'Participants who received placebo (N=581) or an incomplete qHPV vaccine regimen (N=13) were enrolled to receive qHPV vaccine during the base study extension; participants designated as "Not Completed" are those who did not complete all three vaccinations and/or all required follow-up visits.'}, {'id': 'FG003', 'title': 'LTFU: Cohort 1', 'description': 'Participants who received qHPV vaccine in the Base Study with approximately 4 years of follow-up in the Base Study and 10 years of follow-up in the LTFU. Cohort 1 provided a total of approximately 14 years of follow-up post-vaccination.'}, {'id': 'FG004', 'title': 'LTFU: Cohort 2', 'description': 'Participants who received placebo in the Base Study and qHPV vaccine after completion of the Base Study and prior to entry into the LTFU. Cohort 2 provided a total of approximately 10 years of follow-up post-vaccination.'}], 'periods': [{'title': 'Base Study Vaccination Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6087'}, {'groupId': 'FG001', 'numSubjects': '6080'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5916'}, {'groupId': 'FG001', 'numSubjects': '5954'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Randomized not Vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'New Medical History (Not AEs)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Travel', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Site Closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Base Study Follow-Up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up.', 'groupId': 'FG000', 'numSubjects': '5942'}, {'comment': 'Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up.', 'groupId': 'FG001', 'numSubjects': '5971'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5626'}, {'groupId': 'FG001', 'numSubjects': '5277'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '316'}, {'groupId': 'FG001', 'numSubjects': '694'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Travel', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Site Closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Subjects continuing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Subjects in extension', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '371'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Base Study EXT', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '594'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '449'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '145'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Participant moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Travel', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Study ended', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Long-Term Follow-Up (LTFU) Study', 'milestones': [{'type': 'STARTED', 'comment': 'Eligible for inclusion in the LTFU study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Some Base Study participants did not consent for inclusion in the LTFU.', 'groupId': 'FG003', 'numSubjects': '2750'}, {'comment': 'Some Base Study participants did not consent for inclusion in the LTFU.', 'groupId': 'FG004', 'numSubjects': '2097'}]}, {'type': 'Started: Registry-based Effectiveness', 'comment': 'Eligible and consented to inclusion in registry-based searches for effectiveness information', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2650'}, {'groupId': 'FG004', 'numSubjects': '2050'}]}, {'type': 'Started: Immunogenicity Analysis', 'comment': 'Eligible and consented to provide blood samples for immunogenicity anaysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2385'}, {'groupId': 'FG004', 'numSubjects': '1849'}]}, {'type': 'Started: Registry-based Safety', 'comment': 'Eligible and consented to inclusion in registry-based searches for safety information', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2448'}, {'groupId': 'FG004', 'numSubjects': '1888'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2749'}, {'groupId': 'FG004', 'numSubjects': '2097'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Female participants were randomized to receive quadrivalent human papillomavirus (qHPV) vaccine (GARDASIL™) or placebo in the Base Study (V501-015, NCT00092534), and were followed for 4 years. Participants who received placebo in the Base Study were eligible to receive the 3-dose qHPV vaccine series during the Base Study Extension (EXT).', 'preAssignmentDetails': 'Participants who received 3 doses of qHPV vaccine either during the Base Study or Base Study EXT were eligible for enrollment in the Long-Term Follow-Up (LTFU) Study (V501-015-21).\n\nThe 10-year-long registry-based LTFU was conducted at 4 National Registry Study Centers (NRSC) in Denmark, Iceland, Norway, and Sweden.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6087', 'groupId': 'BG000'}, {'value': '6080', 'groupId': 'BG001'}, {'value': '12167', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Base Study Group 1: qHPV Vaccine', 'description': 'During the Base Study, participants received 3 qHPV vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}, {'id': 'BG001', 'title': 'Base Study Group 2: Placebo', 'description': 'During the Base Study, participants received 3 placebo vaccinations (at Day 1, Month 2 and Month 6) and were followed for up to 4 years.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '19.9', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '19.9', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6087', 'groupId': 'BG000'}, {'value': '6080', 'groupId': 'BG001'}, {'value': '12167', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}, {'title': 'Hispanic American', 'measurements': [{'value': '555', 'groupId': 'BG000'}, {'value': '557', 'groupId': 'BG001'}, {'value': '1112', 'groupId': 'BG002'}]}, {'title': 'Native American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4584', 'groupId': 'BG000'}, {'value': '4550', 'groupId': 'BG001'}, {'value': '9134', 'groupId': 'BG002'}]}, {'title': 'Other-Unspecified', 'measurements': [{'value': '625', 'groupId': 'BG000'}, {'value': '610', 'groupId': 'BG001'}, {'value': '1235', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Baseline Analysis population is from the V501-015 Base Study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2004-09-23', 'resultsFirstSubmitDate': '2009-07-20', 'studyFirstSubmitQcDate': '2004-09-27', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-10-15', 'studyFirstPostDateStruct': {'date': '2004-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study', 'timeFrame': 'Up to 4 years', 'description': 'This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine consensus diagnosis of CIN 2 or worse up to 4 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, adenocarcinoma in situ (AIS) or cervical cancer related to HPV 16 or 18.'}, {'measure': 'Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study', 'timeFrame': 'Up to 14 years since Vaccine Dose 1', 'description': 'This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine Nordic pathology panel (NPP) consensus diagnosis of CIN 2 or worse up to 14 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to HPV 16 or 18. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.'}, {'measure': 'Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study', 'timeFrame': 'up to 22 years post Vaccination Dose 1', 'description': 'This measure is defined to have occurred when, on a single cervical biopsy, ECC, LEEP, or conization specimen, there was HPV Vaccine NPP consensus diagnosis of CIN 2 or worse up to 22 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to HPV 16 or 18. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU will be included.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Anti-Human Papillomavirus (HPV) 6 Titer ≥20 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study', 'timeFrame': 'Month 7 (4 weeks after Vaccination 3)', 'description': 'Anti-HPV levels \\>20 mMU/mL neutralize a large input load of HPV 6 pseudovirions in vitro; thus, the number of participants with anti-HPV 6 ≥20 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.'}, {'measure': 'Number of Participants With Anti-Human Papillomavirus (HPV) 11 Titer ≥16 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Anti-HPV levels \\>20 mMU/mL neutralize a large input load of HPV 11 virions in vitro; thus, the number of participants with anti-HPV 11 ≥16 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.'}, {'measure': 'Number of Participants With Anti-Human Papillomavirus (HPV) 16 Titer ≥20 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Anti-HPV levels \\>20 mMU/mL neutralize a large input load of HPV 16 pseudovirions in vitro; thus, the number of participants with anti-HPV 16 ≥20 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.'}, {'measure': 'Number of Participants With Anti-Human Papillomavirus (HPV) 18 Titer ≥24 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Anti-HPV levels \\>20 mMU/mL neutralize a large input load of HPV 18 pseudovirions in vitro; thus, the number of participants with anti-HPV 18 ≥24 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.'}, {'measure': 'Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 31/33/35/39/45/51/52/56/58/59-related Cervical Intraepithelial Neoplasia (CIN) Grade 2 or Worse in the Long-term Follow-up (LTFU) Study', 'timeFrame': 'Up to 14 years since Vaccination Dose 1', 'description': 'This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine Nordic pathology panel (NPP) consensus diagnosis of CIN 2 or worse related to nonvaccine HPV types up to 14 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to nonvaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, or 59. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.'}, {'measure': 'Incidence of the Composite Endpoint of HPV 6/11/16/18-related CIN (Any Grade), AIS, Cervical Cancer, Vulvar Cancer or Vaginal Cancer the Long-term Follow-up (LTFU) Study', 'timeFrame': 'Up to 14 years since Vaccination Dose 1', 'description': 'This measure was defined to have occurred if on a single biopsy or excised tissue, there was the NPP consensus diagnosis of CIN 1, CIN 2, CIN 3, AIS, cervical cancer, vulvar cancer or vaginal cancer AND at least 1 of HPV types 6, 11, 16 or 18 was detected by Thin-section PCR in an adjacent section from the same tissue block. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.'}, {'measure': 'Incidence of the Composite Endpoint of HPV 6/11/16/18-related CIN (Any Grade), AIS, Cervical Cancer, Vulvar Cancer or Vaginal Cancer the Long-term Follow-up (LTFU) Study', 'timeFrame': 'up to 22 years since Vaccination Dose 1', 'description': 'This measure is defined to have occurred if on a single biopsy or excised tissue, there is the NPP consensus diagnosis of CIN 1, CIN 2, CIN 3, AIS, cervical cancer, vulvar cancer or vaginal cancer AND at least 1 of HPV types 6, 11, 16 or 18 is detected by Thin-section PCR in an adjacent section from the same tissue block.'}, {'measure': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 108 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using cLIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.'}, {'measure': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 168 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using cLIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.'}, {'measure': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 108 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using cLIA. Seropositivity was assessed by competitive Luminex Immunoassay (cLIA); the serostatus cut-offs for anti-HPV 6, 11, 16 and 18 serum cLIA were 20, 16, 20 and 24 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.'}, {'measure': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 168 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using cLIA. Seropositivity was assessed by cLIA; the serostatus cut-offs for anti-HPV 6, 11, 16 and 18 serum cLIA were 20, 16, 20 and 24 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.'}, {'measure': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 108 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using IgG LIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.'}, {'measure': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 168 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types were measured using IgG LIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.'}, {'measure': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 108 months since Vaccination Dose 1', 'description': 'Antibodies to HPV types were measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 at Month 108 were 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.'}, {'measure': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 168 months since Vaccination Dose 1', 'description': 'Antibodies to HPV types were measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 at Month 168 were 9, 6, 5, and 5 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.'}, {'measure': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 216 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 216 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types will be measured using IgG LIA..'}, {'measure': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 216 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) ) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 216 months since Vaccination Dose 1', 'description': 'Antibodies to HPV types will be measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 are 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. The percentage of participants that are seropositive for each type will be summarized.'}, {'measure': 'Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 264 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 264 months since Vaccination Dose 1', 'description': 'Antibodies to human papillomavirus (HPV) types will be measured using IgG LIA..'}, {'measure': 'Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 264 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study', 'timeFrame': 'At 264 months since Vaccination Dose 1', 'description': 'Antibodies to HPV types will be measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 are 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. The percentage of participants that are seropositive for each type will be summarized.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Genital Warts']}, 'referencesModule': {'references': [{'pmid': '17494925', 'type': 'BACKGROUND', 'citation': 'FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741.'}, {'pmid': '19199546', 'type': 'BACKGROUND', 'citation': 'Garland SM, Steben M, Sings HL, James M, Lu S, Railkar R, Barr E, Haupt RM, Joura EA. Natural history of genital warts: analysis of the placebo arm of 2 randomized phase III trials of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine. J Infect Dis. 2009 Mar 15;199(6):805-14. doi: 10.1086/597071.'}, {'pmid': '18313445', 'type': 'BACKGROUND', 'citation': 'Barr E, Gause CK, Bautista OM, Railkar RA, Lupinacci LC, Insinga RP, Sings HL, Haupt RM. Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women. Am J Obstet Gynecol. 2008 Mar;198(3):261.e1-11. doi: 10.1016/j.ajog.2007.09.001.'}, {'pmid': '17512854', 'type': 'BACKGROUND', 'citation': 'Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007 May 19;369(9574):1693-702. doi: 10.1016/S0140-6736(07)60777-6.'}, {'pmid': '18000825', 'type': 'BACKGROUND', 'citation': 'Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. doi: 10.1002/ijc.23260.'}, {'pmid': '18008221', 'type': 'BACKGROUND', 'citation': 'FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infect Dis. 2007 Nov 15;196(10):1438-46. doi: 10.1086/522864. Epub 2007 Oct 31.'}, {'pmid': '17544766', 'type': 'BACKGROUND', 'citation': 'Ault KA; Future II Study Group. Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials. Lancet. 2007 Jun 2;369(9576):1861-1868. doi: 10.1016/S0140-6736(07)60852-6.'}, {'pmid': '17955433', 'type': 'BACKGROUND', 'citation': 'Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17.'}, {'pmid': '19505910', 'type': 'BACKGROUND', 'citation': 'Garland SM, Insinga RP, Sings HL, Haupt RM, Joura EA. Human papillomavirus infections and vulvar disease development. Cancer Epidemiol Biomarkers Prev. 2009 Jun;18(6):1777-84. doi: 10.1158/1055-9965.EPI-09-0067.'}, {'pmid': '17943470', 'type': 'BACKGROUND', 'citation': 'Skjeldestad FE, Mehta V, Sings HL, Ovreness T, Turpin J, Su L, Boerckel P, Roberts C, Bryan J, Jansen KU, Esser MT, Liaw KL. Seroprevalence and genital DNA prevalence of HPV types 6, 11, 16 and 18 in a cohort of young Norwegian women: study design and cohort characteristics. Acta Obstet Gynecol Scand. 2008;87(1):81-8. doi: 10.1080/00016340701714703.'}, {'pmid': '26084514', 'type': 'BACKGROUND', 'citation': 'Nygard M, Saah A, Munk C, Tryggvadottir L, Enerly E, Hortlund M, Sigurdardottir LG, Vuocolo S, Kjaer SK, Dillner J. Evaluation of the Long-Term Anti-Human Papillomavirus 6 (HPV6), 11, 16, and 18 Immune Responses Generated by the Quadrivalent HPV Vaccine. Clin Vaccine Immunol. 2015 Aug;22(8):943-8. doi: 10.1128/CVI.00133-15. Epub 2015 Jun 17.'}, {'pmid': '18555997', 'type': 'BACKGROUND', 'citation': 'Tay EH, Garland S, Tang G, Nolan T, Huang LM, Orloski L, Lu S, Barr E. Clinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region. Int J Gynaecol Obstet. 2008 Sep;102(3):275-83. doi: 10.1016/j.ijgo.2008.03.021. Epub 2008 Jun 16.'}, {'pmid': '19453788', 'type': 'BACKGROUND', 'citation': 'Majewski S, Bosch FX, Dillner J, Iversen OE, Kjaer SK, Munoz N, Olsson SE, Paavonen J, Sigurdsson K, Bryan J, Esser MT, Giacoletti K, James M, Taddeo F, Vuocolo S, Barr E. The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24. J Eur Acad Dermatol Venereol. 2009 Oct;23(10):1147-55. doi: 10.1111/j.1468-3083.2009.03266.x. Epub 2009 Apr 23.'}, {'pmid': '19789295', 'type': 'BACKGROUND', 'citation': 'Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Brown DR, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Lehtinen M, Steben M, Bosch FX, Dillner J, Joura EA, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Maansson R, Lu S, Vuocolo S, Hesley TM, Saah A, Barr E, Haupt RM. A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (Types 6/11/16/18) vaccine against high-grade cervical and external genital lesions. Cancer Prev Res (Phila). 2009 Oct;2(10):868-78. doi: 10.1158/1940-6207.CAPR-09-0031. Epub 2009 Sep 29.'}, {'pmid': '20647284', 'type': 'BACKGROUND', 'citation': 'FUTURE I/II Study Group; Dillner J, Kjaer SK, Wheeler CM, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Lehtinen M, Steben M, Bosch FX, Joura EA, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan JT, Maansson R, Lu S, Vuocolo S, Hesley TM, Barr E, Haupt R. Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial. BMJ. 2010 Jul 20;341:c3493. doi: 10.1136/bmj.c3493.'}, {'pmid': '19855170', 'type': 'BACKGROUND', 'citation': 'Olsson SE, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Brown DR, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Tang GW, Ferris DG, Paavonen J, Lehtinen M, Steben M, Bosch FX, Dillner J, Joura EA, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Maansson R, Vuocolo S, Hesley TM, Saah A, Barr E, Haupt RM. Evaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection. Hum Vaccin. 2009 Oct;5(10):696-704. doi: 10.4161/hv.5.10.9515. Epub 2009 Oct 1.'}, {'pmid': '21491420', 'type': 'BACKGROUND', 'citation': 'Haupt RM, Wheeler CM, Brown DR, Garland SM, Ferris DG, Paavonen JA, Lehtinen MO, Steben M, Joura EA, Giacoletti KE, Radley DR, James MK, Saah AJ, Sings HL; FUTURE I and II Investigators. Impact of an HPV6/11/16/18 L1 virus-like particle vaccine on progression to cervical intraepithelial neoplasia in seropositive women with HPV16/18 infection. Int J Cancer. 2011 Dec 1;129(11):2632-42. doi: 10.1002/ijc.25940. Epub 2011 Apr 13.'}, {'pmid': '29029053', 'type': 'RESULT', 'citation': 'Kjaer SK, Nygard M, Dillner J, Brooke Marshall J, Radley D, Li M, Munk C, Hansen BT, Sigurdardottir LG, Hortlund M, Tryggvadottir L, Joshi A, Das R, Saah AJ. A 12-Year Follow-up on the Long-Term Effectiveness of the Quadrivalent Human Papillomavirus Vaccine in 4 Nordic Countries. Clin Infect Dis. 2018 Jan 18;66(3):339-345. doi: 10.1093/cid/cix797.'}, {'pmid': '41166720', 'type': 'DERIVED', 'citation': 'Joura E, Kjaer SK, Bautista O, Luxembourg A, Saah A, Giuliano A. Effect of Prior 9-Valent Human Papillomavirus Vaccination on Subsequent Lower Genital Tract Dysplasia After Cervical Excisional Surgery. Obstet Gynecol. 2025 Oct 30. doi: 10.1097/AOG.0000000000006113. Online ahead of print.'}, {'pmid': '35149535', 'type': 'DERIVED', 'citation': 'Lehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Bly A, Gray P, Harjula K, Heikkila K, Hokkanen M, Karttunen H, Kuortti M, Nieminen P, Nummela M, Paavonen J, Palmroth J, Petaja T, Pukkala E, Soderlund-Strand A, Veivo U, Dillner J. Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial. BMJ Open. 2021 Dec 30;11(12):e050669. doi: 10.1136/bmjopen-2021-050669.'}, {'pmid': '32247041', 'type': 'DERIVED', 'citation': 'Enerly E, Berger S, Kjaer SK, Sundstrom K, Campbell S, Tryggvadottir L, Munk C, Hortlund M; Thomas Group. Electronic address: thomas_group@merck.com; Joshi A, Saah AJ, Nygard M. Use of real-world data for HPV vaccine trial follow-up in the Nordic region. Contemp Clin Trials. 2020 May;92:105996. doi: 10.1016/j.cct.2020.105996. Epub 2020 Apr 1.'}, {'pmid': '32184277', 'type': 'DERIVED', 'citation': 'Doshi P, Bourgeois F, Hong K, Jones M, Lee H, Shamseer L, Spence O, Jefferson T. Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology. BMJ Evid Based Med. 2020 Dec;25(6):213-219. doi: 10.1136/bmjebm-2019-111331. Epub 2020 Mar 17.'}, {'pmid': '30982556', 'type': 'DERIVED', 'citation': 'Giuliano AR, Joura EA, Garland SM, Huh WK, Iversen OE, Kjaer SK, Ferenczy A, Kurman RJ, Ronnett BM, Stoler MH, Bautista OM, Moeller E, Ritter M, Shields C, Luxembourg A. Nine-valent HPV vaccine efficacy against related diseases and definitive therapy: comparison with historic placebo population. Gynecol Oncol. 2019 Jul;154(1):110-117. doi: 10.1016/j.ygyno.2019.03.253. Epub 2019 Apr 11.'}, {'pmid': '29995724', 'type': 'DERIVED', 'citation': 'Garland SM, Joura EA, Ault KA, Bosch FX, Brown DR, Castellsague X, Ferenczy A, Ferris DG, Giuliano AR, Hernandez-Avila M, Huh WK, Iversen OE, Kjaer SK, Kurman RJ, Luna J, Monsonego J, Munoz N, Paavonen J, Pitisuttihum P, Ronnett BM, Steben M, Stoler MH, Wheeler CM, Wiley DJ, Perez G, Saah AJ, Luxembourg A, Li S, DiNubile MJ, Wagner M, Velicer C. Human Papillomavirus Genotypes From Vaginal and Vulvar Intraepithelial Neoplasia in Females 15-26 Years of Age. Obstet Gynecol. 2018 Aug;132(2):261-270. doi: 10.1097/AOG.0000000000002736.'}, {'pmid': '29074187', 'type': 'DERIVED', 'citation': 'Castellsague X, Ault KA, Bosch FX, Brown D, Cuzick J, Ferris DG, Joura EA, Garland SM, Giuliano AR, Hernandez-Avila M, Huh W, Iversen OE, Kjaer SK, Luna J, Monsonego J, Munoz N, Myers E, Paavonen J, Pitisuttihum P, Steben M, Wheeler CM, Perez G, Saah A, Luxembourg A, Sings HL, Velicer C. Human papillomavirus detection in cervical neoplasia attributed to 12 high-risk human papillomavirus genotypes by region. Papillomavirus Res. 2016 Dec;2:61-69. doi: 10.1016/j.pvr.2016.03.002. Epub 2016 Mar 14.'}, {'pmid': '23299013', 'type': 'DERIVED', 'citation': 'Clark LR, Myers ER, Huh W, Joura EA, Paavonen J, Perez G, James MK, Sings HL, Haupt RM, Saah AJ, Garner EI. Clinical trial experience with prophylactic human papillomavirus 6/11/16/18 vaccine in young black women. J Adolesc Health. 2013 Mar;52(3):322-9. doi: 10.1016/j.jadohealth.2012.07.003. Epub 2012 Aug 15.'}, {'pmid': '23066159', 'type': 'DERIVED', 'citation': 'Ruiz AM, Ruiz JE, Gavilanes AV, Eriksson T, Lehtinen M, Perez G, Sings HL, James MK, Haupt RM; FUTURE I and II Study Group. Proximity of first sexual intercourse to menarche and risk of high-grade cervical disease. J Infect Dis. 2012 Dec 15;206(12):1887-96. doi: 10.1093/infdis/jis612. Epub 2012 Oct 12.'}, {'pmid': '22454089', 'type': 'DERIVED', 'citation': 'Joura EA, Garland SM, Paavonen J, Ferris DG, Perez G, Ault KA, Huh WK, Sings HL, James MK, Haupt RM; FUTURE I and II Study Group. Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data. BMJ. 2012 Mar 27;344:e1401. doi: 10.1136/bmj.e1401.'}, {'pmid': '21471141', 'type': 'DERIVED', 'citation': 'Lehtinen M, Ault KA, Lyytikainen E, Dillner J, Garland SM, Ferris DG, Koutsky LA, Sings HL, Lu S, Haupt RM, Paavonen J; FUTURE I and II Study Group. Chlamydia trachomatis infection and risk of cervical intraepithelial neoplasia. Sex Transm Infect. 2011 Aug;87(5):372-6. doi: 10.1136/sti.2010.044354. Epub 2011 Apr 6.'}, {'pmid': '20949623', 'type': 'DERIVED', 'citation': 'Ault KA, Joura EA, Kjaer SK, Iversen OE, Wheeler CM, Perez G, Brown DR, Koutsky LA, Garland SM, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Majewski S, Munoz N, Sings HL, Harkins K, Rutkowski MA, Haupt RM, Garner EI; FUTURE I and II Study Group. Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine. Int J Cancer. 2011 Mar 15;128(6):1344-53. doi: 10.1002/ijc.25723. Epub 2011 Jan 12.'}, {'pmid': '19935017', 'type': 'DERIVED', 'citation': 'Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21.'}, {'pmid': '19236279', 'type': 'DERIVED', 'citation': 'Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, Sings HL, James M, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):926-35. doi: 10.1086/597307.'}, {'pmid': '19236277', 'type': 'DERIVED', 'citation': 'Wheeler CM, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, James M, Vuocolo S, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):936-44. doi: 10.1086/597309.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.', 'detailedDescription': 'In the 4-year Base Study (V501-015) (NCT00092534), participants were randomized in a 1:1 order to receive 3 doses of GARDASIL™ or matching placebo at Day 1, Month 2, and Month 6 and were assessed for efficacy, immunogenicity, and safety.\n\nIn the Base Study Extension (EXT) \\[V501-015-10\\], participants who received placebo or only 1 dose of GARDASIL™ in the Base Study, were given 3 doses of open-label GARDASIL™ at EXT Day 1, EXT Month 2, and EXT Month 6, and were followed to EXT Month 7. Participants who who received 2 doses of GARDASIL™ in the Base Study were given 1 dose of GARDASIL™ at EXT Day 1 and were followed for 15 days (day of vaccination plus 14 days).\n\nIn the 10-year Base Study Long-Term Follow-Up (LTFU) \\[V501-015-21\\] the effectiveness, immunogenicity and safety of GARDASIL™ was assessed during a period of 10 years following completion of the Base Study (V501-015) \\[14 years after the first dose of GARDASIL™\\] and, for some measures, the Base Study EXT (V501-015-10) \\[10 years after the first dose of GARDASIL™\\]. Participants from Denmark, Iceland, Norway and Sweden who participated in the Base Study were eligible to enroll in the LTFU. Effectiveness and safety was assessed by registry-based follow-up, and immunogenicity was assessed by serological testing at approximately Year 5 and Year 10 of the V501-015-21 LTFU.\n\nAn 8-year extension was added to the LTFU (V501-015-22\\] to continue the evaluation of the long-term effectiveness and immunogenicity of GARDASIL™. Effectiveness and safety will be assessed by registry-based follow-up, and immunogenicity will be assessed by serological testing at approximately Year 4 and Year 8 of the extension of the LTFU.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for the Base Study:\n\n* Healthy women with an intact uterus with lifetime history of 0-4 sexual partners\n\n --For Extension Phase:\n* Participant received placebo or an incomplete vaccination series in the original study\n\n --For LTFU:\n* Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.\n* Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection\n\nExclusion Criteria for the Base Study:\n\n* Prior Human Papilloma Virus (HPV) vaccination\n* Prior abnormal Paps\n* Prior history of genital warts\n\n --For Extension Phase:\n* Prior complete HPV vaccination series\n* Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil\n\n --For LTFU Study:\n* There were no exclusion criteria that did not overlap the inclusion criteria for this study.'}, 'identificationModule': {'nctId': 'NCT00092534', 'acronym': 'FUTURE II', 'briefTitle': 'Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year Old Women - The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)', 'orgStudyIdInfo': {'id': 'V501-015'}, 'secondaryIdInfos': [{'id': '2004_082'}, {'id': 'V501-015', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadrivalent Human Papillomavirus (HPV) Vaccine', 'description': 'The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.', 'interventionNames': ['Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.', 'interventionNames': ['Biological: Matching Placebo']}], 'interventions': [{'name': 'Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['V501, qHPV vaccine'], 'description': 'A 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.', 'armGroupLabels': ['Quadrivalent Human Papillomavirus (HPV) Vaccine']}, {'name': 'Matching Placebo', 'type': 'BIOLOGICAL', 'description': 'A placebo 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}