Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-31 @ 1:20 PM
Study NCT ID:
NCT00092495
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2004-09-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
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', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Of note, the number of subjects who completed the Vaccination Period (N=1441) is slightly higher than that specified in the publication by Block, et al (2006; N=1430). The data provided here is based on final data.'}}, 'adverseEventsModule': {'description': 'Adverse events were collected from subjects with follow-up.', 'eventGroups': [{'id': 'EG000', 'title': '20% Formulation', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.', 'otherNumAtRisk': 496, 'otherNumAffected': 434, 'seriousNumAtRisk': 496, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '40% Formulation', 'description': 'Subjects in this group received a 40% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.', 'otherNumAtRisk': 509, 'otherNumAffected': 426, 'seriousNumAtRisk': 509, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '60% Formulation', 'description': 'Subjects in this group received a 60% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.', 'otherNumAtRisk': 500, 'otherNumAffected': 431, 'seriousNumAtRisk': 500, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '100% Formulation', 'description': 'Subjects in this group received a 100% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.', 'otherNumAtRisk': 1498, 'otherNumAffected': 1276, 'seriousNumAtRisk': 1498, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 36, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 67, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 157, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 163, 'numAffected': 116}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 157, 'numAffected': 113}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 436, 'numAffected': 324}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 863, 'numAffected': 402}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 881, 'numAffected': 395}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 879, 'numAffected': 395}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 2535, 'numAffected': 1184}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 179, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 201, 'numAffected': 130}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 172, 'numAffected': 121}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 500, 'numAffected': 359}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 89, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 93, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 59, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 238, 'numAffected': 196}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 36, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 70, 'numAffected': 70}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 43, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 202, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 176, 'numAffected': 120}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 221, 'numAffected': 143}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 490, 'numAffected': 348}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tachycardia foetal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cephalo-pelvic disproportion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Failed trial of labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperemesis gravidarum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Premature rupture of membranes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anorexia nervosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 496, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1498, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls 10-15 Years'}, {'id': 'OG001', 'title': 'Boys 10-15 Years'}, {'id': 'OG002', 'title': 'Women 16-23 Years'}], 'classes': [{'title': 'HPV 6 ≥ 20 mMU/mL', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}]}, {'title': 'HPV 6 < 20 mMU/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (girls - women) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (boys - women) must be greater than -5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls 10-15 Years'}, {'id': 'OG001', 'title': 'Boys 10-15 Years'}, {'id': 'OG002', 'title': 'Women 16-23 Years'}], 'classes': [{'categories': [{'measurements': [{'value': '987.3', 'groupId': 'OG000', 'lowerLimit': '905.0', 'upperLimit': '1077.0'}, {'value': '1116.1', 'groupId': 'OG001', 'lowerLimit': '1022.7', 'upperLimit': '1218.1'}, {'value': '603.0', 'groupId': 'OG002', 'lowerLimit': '548.5', 'upperLimit': '662.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (girls/women) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (boys/women) must be greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': ': Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}, {'value': '743', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': '40% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG002', 'title': '60% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6'}, {'id': 'OG003', 'title': '100% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}], 'classes': [{'title': 'HPV 6 ≥ 20 mMU/mL', 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}, {'value': '363', 'groupId': 'OG002'}, {'value': '743', 'groupId': 'OG003'}]}]}, {'title': 'HPV 6 < 20 mMU/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}, {'value': '743', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': '40% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG002', 'title': '60% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6'}, {'id': 'OG003', 'title': '100% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '584.2', 'groupId': 'OG000', 'lowerLimit': '526.7', 'upperLimit': '647.9'}, {'value': '704.5', 'groupId': 'OG001', 'lowerLimit': '636.6', 'upperLimit': '779.7'}, {'value': '707.5', 'groupId': 'OG002', 'lowerLimit': '632.5', 'upperLimit': '791.2'}, {'value': '798.4', 'groupId': 'OG003', 'lowerLimit': '747.1', 'upperLimit': '853.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls 10-15 Years'}, {'id': 'OG001', 'title': 'Boys 10-15 Years'}, {'id': 'OG002', 'title': 'Women 16-23 Years'}], 'classes': [{'title': 'HPV 11 ≥ 16 mMU/mL', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}]}, {'title': 'HPV 11 < 16 mMU/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (girls - women) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (boys - women) must be greater than -5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls 10-15 Years'}, {'id': 'OG001', 'title': 'Boys 10-15 Years'}, {'id': 'OG002', 'title': 'Women 16-23 Years'}], 'classes': [{'categories': [{'measurements': [{'value': '1264.0', 'groupId': 'OG000', 'lowerLimit': '1153.2', 'upperLimit': '1385.4'}, {'value': '1396.5', 'groupId': 'OG001', 'lowerLimit': '1271.4', 'upperLimit': '1534.0'}, {'value': '739.2', 'groupId': 'OG002', 'lowerLimit': '665.6', 'upperLimit': '821.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (girls/women) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (boys/women) must be greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}, {'value': '743', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': '40% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG002', 'title': '60% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6'}, {'id': 'OG003', 'title': '100% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}], 'classes': [{'title': 'HPV 11 ≥ 16 mMU/mL', 'categories': [{'measurements': [{'value': '373', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}, {'value': '743', 'groupId': 'OG003'}]}]}, {'title': 'HPV 11 < 16 mMU/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}, {'value': '743', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': '40% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG002', 'title': '60% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6'}, {'id': 'OG003', 'title': '100% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '632.1', 'groupId': 'OG000', 'lowerLimit': '565.2', 'upperLimit': '706.8'}, {'value': '804.7', 'groupId': 'OG001', 'lowerLimit': '723.9', 'upperLimit': '894.4'}, {'value': '836.2', 'groupId': 'OG002', 'lowerLimit': '743.7', 'upperLimit': '940.2'}, {'value': '1003.2', 'groupId': 'OG003', 'lowerLimit': '934.0', 'upperLimit': '1077.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': ': Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls 10-15 Years'}, {'id': 'OG001', 'title': 'Boys 10-15 Years'}, {'id': 'OG002', 'title': 'Women 16-23 Years'}], 'classes': [{'title': 'HPV 16 ≥ 20 mMU/mL', 'categories': [{'measurements': [{'value': '424', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}]}, {'title': 'HPV 16 < 20 mMU/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (girls - women) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (boys - women) must be greater than -5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.', 'unitOfMeasure': 'mMU/mL', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls 10-15 Years'}, {'id': 'OG001', 'title': 'Boys 10-15 Years'}, {'id': 'OG002', 'title': 'Women 16-23 Years'}], 'classes': [{'categories': [{'measurements': [{'value': '4848.8', 'groupId': 'OG000', 'lowerLimit': '4350.2', 'upperLimit': '5404.5'}, {'value': '5923.0', 'groupId': 'OG001', 'lowerLimit': '5325.2', 'upperLimit': '6587.9'}, {'value': '2753.0', 'groupId': 'OG002', 'lowerLimit': '2400.5', 'upperLimit': '3157.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (girls/women) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (boys/women) must be greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}, {'value': '730', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': '40% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG002', 'title': '60% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6'}, {'id': 'OG003', 'title': '100% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}], 'classes': [{'title': 'HPV 16 ≥ 20 mMU/mL', 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}, {'value': '730', 'groupId': 'OG003'}]}]}, {'title': 'HPV 16 < 20 mMU/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}, {'value': '730', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': '40% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG002', 'title': '60% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6'}, {'id': 'OG003', 'title': '100% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '2401.1', 'groupId': 'OG000', 'lowerLimit': '2084.0', 'upperLimit': '2766.6'}, {'value': '2963.3', 'groupId': 'OG001', 'lowerLimit': '2593.3', 'upperLimit': '3386.0'}, {'value': '3105.3', 'groupId': 'OG002', 'lowerLimit': '2692.8', 'upperLimit': '3581.1'}, {'value': '3824.6', 'groupId': 'OG003', 'lowerLimit': '3504.4', 'upperLimit': '4174.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls 10-15 Years'}, {'id': 'OG001', 'title': 'Boys 10-15 Years'}, {'id': 'OG002', 'title': 'Women 16-23 Years'}], 'classes': [{'title': 'HPV 18 ≥ 24 mMU/mL', 'categories': [{'measurements': [{'value': '426', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}, {'value': '337', 'groupId': 'OG002'}]}]}, {'title': 'HPV 18 < 24 mMU/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (girls - women) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (boys - women) must be greater than -5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls 10-15 Years'}, {'id': 'OG001', 'title': 'Boys 10-15 Years'}, {'id': 'OG002', 'title': 'Women 16-23 Years'}], 'classes': [{'categories': [{'measurements': [{'value': '953.6', 'groupId': 'OG000', 'lowerLimit': '857.3', 'upperLimit': '1060.7'}, {'value': '1232.9', 'groupId': 'OG001', 'lowerLimit': '1105.6', 'upperLimit': '1375.0'}, {'value': '470.5', 'groupId': 'OG002', 'lowerLimit': '418.5', 'upperLimit': '528.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (girls/women) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (boys/women) must be greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}, {'value': '766', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': '40% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG002', 'title': '60% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6'}, {'id': 'OG003', 'title': '100% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}], 'classes': [{'title': 'HPV 18 ≥ 24 mMU/mL', 'categories': [{'measurements': [{'value': '381', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}, {'value': '375', 'groupId': 'OG002'}, {'value': '763', 'groupId': 'OG003'}]}]}, {'title': 'HPV 18 < 24 mMU/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Miettinen and Nurminen method for difference in proportions\n\nMiettinen and Nurminen, Stat Med 1985;4:213-26', 'testedNonInferiority': True, 'nonInferiorityComment': 'The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}, {'value': '766', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '20% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': '40% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'OG002', 'title': '60% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6'}, {'id': 'OG003', 'title': '100% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '544.0', 'groupId': 'OG000', 'lowerLimit': '480.9', 'upperLimit': '615.3'}, {'value': '640.4', 'groupId': 'OG001', 'lowerLimit': '570.5', 'upperLimit': '718.9'}, {'value': '647.5', 'groupId': 'OG002', 'lowerLimit': '571.6', 'upperLimit': '733.5'}, {'value': '696.9', 'groupId': 'OG003', 'lowerLimit': '641.7', 'upperLimit': '756.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA on natural log titer with fixed effects for region and comparison group.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ratio of GMTs (partial dose/full dose) must be greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '20% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'FG001', 'title': '40% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'FG002', 'title': '60% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6'}, {'id': 'FG003', 'title': '100% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'FG004', 'title': 'Extension Study', 'description': 'Extension Study: This group includes 12 subjects who participated in the base study and received either a partial dose formulation of the quadrivalent HPV vaccine in the base study and did not meet the protocol specified criteria for seroconversion, or subjects who, due to pregnancy, received 1 or 2 doses of the quadrivalent HPV vaccine in the base study and remained in the study through Month 7. The Extension Period began after all patients had completed the Month 7 follow-up period. Subjects designated as "Completed Period" are those who at the end of the study had received three injections of quadrivalent HPV vaccine and completed all follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.'}], 'periods': [{'title': 'Base Study Vaccination Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '504'}, {'groupId': 'FG001', 'numSubjects': '514'}, {'groupId': 'FG002', 'numSubjects': '508'}, {'groupId': 'FG003', 'numSubjects': '1529'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'With Long-term Follow-up *', 'achievements': [{'comment': 'Subjects received fewer than 3 doses of vaccinations and entered the long-term follow-up period', 'groupId': 'FG000', 'numSubjects': '2'}, {'comment': 'Subjects received fewer than 3 doses of vaccinations and entered the long-term follow-up period', 'groupId': 'FG001', 'numSubjects': '2'}, {'comment': 'Subjects received fewer than 3 doses of vaccinations and entered the long-term follow-up period', 'groupId': 'FG002', 'numSubjects': '6'}, {'comment': 'Subjects received fewer than 3 doses of vaccinations and entered the long-term follow-up period', 'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Without Long-term Follow-up', 'achievements': [{'comment': 'Subjects discontinued on or before Month 7 and did not enter the long-term follow-up period', 'groupId': 'FG000', 'numSubjects': '34'}, {'comment': 'Subjects discontinued on or before Month 7 and did not enter the long-term follow-up period', 'groupId': 'FG001', 'numSubjects': '20'}, {'comment': 'Subjects discontinued on or before Month 7 and did not enter the long-term follow-up period', 'groupId': 'FG002', 'numSubjects': '28'}, {'comment': 'Subjects discontinued on or before Month 7 and did not enter the long-term follow-up period', 'groupId': 'FG003', 'numSubjects': '73'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 3 vaccinations; entered the long-term follow-up or completed the study per-protocol', 'groupId': 'FG000', 'numSubjects': '467'}, {'comment': 'Completed 3 vaccinations; entered the long-term follow-up or completed the study per-protocol', 'groupId': 'FG001', 'numSubjects': '492'}, {'comment': 'Completed 3 vaccinations; entered the long-term follow-up or completed the study per-protocol', 'groupId': 'FG002', 'numSubjects': '474'}, {'comment': 'Completed 3 vaccinations; entered the long-term follow-up or completed the study per-protocol', 'groupId': 'FG003', 'numSubjects': '1441'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '88'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Randomized Not Vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Extended', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': '*Clinical AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': '*Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': '*Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Parent Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Base Study Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Protocol amended to extend follow-up for 10-15 year old subjects to Month 12 (6 months Postdose 3)', 'groupId': 'FG000', 'numSubjects': '115'}, {'comment': 'Protocol amended to extend follow-up for 10-15 year old subjects to Month 12 (6 months Postdose 3)', 'groupId': 'FG001', 'numSubjects': '125'}, {'comment': 'Protocol amended to extend follow-up for 10-15 year old subjects to Month 12 (6 months Postdose 3)', 'groupId': 'FG002', 'numSubjects': '130'}, {'comment': 'Protocol amended to extend follow-up for 10-15 year old subjects to Month 12 (6 months Postdose 3)', 'groupId': 'FG003', 'numSubjects': '460'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '126'}, {'groupId': 'FG003', 'numSubjects': '446'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Extended', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '504', 'groupId': 'BG000'}, {'value': '514', 'groupId': 'BG001'}, {'value': '508', 'groupId': 'BG002'}, {'value': '1529', 'groupId': 'BG003'}, {'value': '3055', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '20% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'BG001', 'title': '40% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'BG002', 'title': '60% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6'}, {'id': 'BG003', 'title': '100% Formulation qHPV Vaccine', 'description': 'Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '23'}, {'value': '16.5', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '24'}, {'value': '16.2', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '23'}, {'value': '15.1', 'groupId': 'BG003', 'lowerLimit': '10', 'upperLimit': '23'}, {'value': '15.7', 'spread': '10', 'groupId': 'BG004', 'lowerLimit': '10', 'upperLimit': '24'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '10 to 11 Years of Age', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}, {'value': '528', 'groupId': 'BG004'}]}]}, {'title': '12 to 13 Years of Age', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '370', 'groupId': 'BG003'}, {'value': '676', 'groupId': 'BG004'}]}]}, {'title': '14 to 15 Years of Age', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '344', 'groupId': 'BG003'}, {'value': '571', 'groupId': 'BG004'}]}]}, {'title': '16 to 17 Years of Age', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '176', 'groupId': 'BG004'}]}]}, {'title': '18 to 19 Years of Age', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}, {'value': '316', 'groupId': 'BG004'}]}]}, {'title': '20 to 21 Years of Age', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}, {'value': '434', 'groupId': 'BG004'}]}]}, {'title': '22 to 23 Years of Age', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}, {'value': '353', 'groupId': 'BG004'}]}]}, {'title': 'Over 23 Years of Age', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '504', 'groupId': 'BG000'}, {'value': '514', 'groupId': 'BG001'}, {'value': '508', 'groupId': 'BG002'}, {'value': '1019', 'groupId': 'BG003'}, {'value': '2545', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}, {'value': '510', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3055}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2004-09-22', 'resultsFirstSubmitDate': '2010-02-15', 'studyFirstSubmitQcDate': '2004-09-24', 'lastUpdatePostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-15', 'studyFirstPostDateStruct': {'date': '2004-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).'}, {'measure': 'Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3', 'timeFrame': 'Week 4 Postdose 3 (Month 7)'}, {'measure': 'Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).'}, {'measure': 'Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3', 'timeFrame': 'Week 4 Postdose 3 (Month 7)'}, {'measure': 'Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.'}, {'measure': 'Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3', 'timeFrame': 'Week 4 Postdose 3 (Month 7)'}, {'measure': 'Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL).'}, {'measure': 'Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3', 'timeFrame': 'Week 4 Postdose 3 (Month 7)', 'description': 'Seroconversion is defined as going from seronegative to seropositive.\n\nSeropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).'}, {'measure': 'Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3', 'timeFrame': 'Week 4 Postdose 3 (Month 7)'}]}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Genital Warts']}, 'referencesModule': {'references': [{'pmid': '17079588', 'type': 'BACKGROUND', 'citation': 'Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461.'}, {'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': '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': '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': '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': '19453788', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adolescents and pre-adolescents with no prior sexual history\n* Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners\n\nExclusion Criteria:\n\n* Prior Human Papillomavirus (HPV) vaccination\n* Prior abnormal Paps\n* Prior history of genital warts'}, 'identificationModule': {'nctId': 'NCT00092495', 'briefTitle': 'Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine', 'orgStudyIdInfo': {'id': 'V501-016'}, 'secondaryIdInfos': [{'id': '2004_083'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '100% Formulation qHPV Vaccine', 'interventionNames': ['Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '60% Formulation qHPV Vaccine', 'interventionNames': ['Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '40% Formulation qHPV Vaccine', 'interventionNames': ['Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': '20% Formulation qHPV Vaccine', 'interventionNames': ['Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine']}], 'interventions': [{'name': 'V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['V501', 'Gardasil'], 'description': 'qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}