Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT03158220
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D003218', 'term': 'Condylomata Acuminata'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], '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': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 month post vaccination 3 (up to 7 months)', 'description': 'Population included all participants that received at least 1 vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Women 16-26 Years of Age', 'description': 'Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.', 'otherNumAtRisk': 570, 'deathsNumAtRisk': 570, 'otherNumAffected': 518, 'seriousNumAtRisk': 570, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Women 27-45 Years of Age', 'description': 'Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.', 'otherNumAtRisk': 640, 'deathsNumAtRisk': 640, 'otherNumAffected': 574, 'seriousNumAtRisk': 640, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 35, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 32, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 36, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 42, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 166, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 163, 'numAffected': 111}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 1246, 'numAffected': 492}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1244, 'numAffected': 532}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 206, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 224, 'numAffected': 152}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 40, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 57, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 69, 'numAffected': 56}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 297, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 320, 'numAffected': 200}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 65, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 27, 'numAffected': 22}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 44, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 53, 'numAffected': 46}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Basilar migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Foetal death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 570, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women 16-26 Years of Age', 'description': 'Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'Women 27-45 Years of Age', 'description': 'Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}], 'classes': [{'title': 'Anti-HPV 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '787.8', 'groupId': 'OG000', 'lowerLimit': '732.5', 'upperLimit': '847.2'}, {'value': '638.4', 'groupId': 'OG001', 'lowerLimit': '594.9', 'upperLimit': '685.0'}]}]}, {'title': 'Anti-HPV 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '598.7', 'groupId': 'OG000', 'lowerLimit': '558.7', 'upperLimit': '641.6'}, {'value': '453.5', 'groupId': 'OG001', 'lowerLimit': '424.1', 'upperLimit': '485.0'}]}]}, {'title': 'Anti-HPV 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3075.8', 'groupId': 'OG000', 'lowerLimit': '2863.4', 'upperLimit': '3303.9'}, {'value': '2147.5', 'groupId': 'OG001', 'lowerLimit': '2001.1', 'upperLimit': '2304.5'}]}]}, {'title': 'Anti-HPV 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '744.5', 'groupId': 'OG000', 'lowerLimit': '685.0', 'upperLimit': '809.1'}, {'value': '532.1', 'groupId': 'OG001', 'lowerLimit': '491.8', 'upperLimit': '575.7'}]}]}, {'title': 'Anti-HPV 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '488', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '596.1', 'groupId': 'OG000', 'lowerLimit': '551.1', 'upperLimit': '644.9'}, {'value': '395.7', 'groupId': 'OG001', 'lowerLimit': '367.0', 'upperLimit': '426.6'}]}]}, {'title': 'Anti-HPV 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '493', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '354.5', 'groupId': 'OG000', 'lowerLimit': '331.7', 'upperLimit': '378.9'}, {'value': '259.0', 'groupId': 'OG001', 'lowerLimit': '242.9', 'upperLimit': '276.1'}]}]}, {'title': 'Anti-HPV 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '214.9', 'groupId': 'OG000', 'lowerLimit': '197.7', 'upperLimit': '233.7'}, {'value': '145.6', 'groupId': 'OG001', 'lowerLimit': '134.4', 'upperLimit': '157.7'}]}]}, {'title': 'Anti-HPV 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '346.5', 'groupId': 'OG000', 'lowerLimit': '324.0', 'upperLimit': '370.5'}, {'value': '244.7', 'groupId': 'OG001', 'lowerLimit': '229.4', 'upperLimit': '261.0'}]}]}, {'title': 'Anti-HPV 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '428.0', 'groupId': 'OG000', 'lowerLimit': '399.4', 'upperLimit': '458.6'}, {'value': '296.4', 'groupId': 'OG001', 'lowerLimit': '277.1', 'upperLimit': '317.0'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fold Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.77', 'pValueComment': 'Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.', 'estimateComment': 'Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds', 'groupDescription': 'Anti HPV 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fold Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.80', 'pValueComment': 'Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.', 'estimateComment': 'Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds', 'groupDescription': 'Anti HPV 18', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fold Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.74', 'pValueComment': 'ANOVA model with response of log individual titers and a fixed effect for age groups.', 'estimateComment': 'Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds', 'groupDescription': 'Anti HPV 31', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fold Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.80', 'pValueComment': 'ANOVA model with response of log individual titers and a fixed effect for age groups.', 'estimateComment': 'Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds', 'groupDescription': 'Anti HPV 33', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fold Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.76', 'pValueComment': 'ANOVA model with response of log individual titers and a fixed effect for age groups.', 'estimateComment': 'Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds', 'groupDescription': 'Anti HPV 45', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fold Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.78', 'pValueComment': 'ANOVA model with response of log individual titers and a fixed effect for age groups.', 'estimateComment': 'Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds', 'groupDescription': 'Anti HPV 52', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fold Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.76', 'pValueComment': 'ANOVA model with response of log individual titers and a fixed effect for age groups.', 'estimateComment': 'Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds', 'groupDescription': 'Anti HPV 58', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks post vaccination 3 (Month 7)', 'description': 'Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants That Experienced at Least 1 Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '570', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women 16-26 Years of Age', 'description': 'Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'Women 27-45 Years of Age', 'description': 'Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000'}, {'value': '92.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month post vaccination 3 (up to 7 months)', 'description': "An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that received at least 1 vaccination and had available data for endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '570', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women 16-26 Years of Age', 'description': 'Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'Women 27-45 Years of Age', 'description': 'Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month post vaccination 3 (up to 7 months)', 'description': "An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that received at least 1 vaccination and had available data for endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '570', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women 16-26 Years of Age', 'description': 'Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'Women 27-45 Years of Age', 'description': 'Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.2', 'groupId': 'OG000'}, {'value': '84.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.212', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '1.4', 'estimateComment': 'Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days post any vaccination', 'description': 'Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that received at least 1 vaccination and had available data for endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants That Reported at Least 1 Systemic Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '570', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women 16-26 Years of Age', 'description': 'Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'Women 27-45 Years of Age', 'description': 'Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '3.4', 'estimateComment': 'Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 15 days post any vaccination', 'description': 'An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that received at least 1 vaccination and had available data for endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Elevated Temperature (Fever)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '570', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women 16-26 Years of Age', 'description': 'Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'Women 27-45 Years of Age', 'description': 'Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.300', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '0.9', 'estimateComment': 'Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days post any vaccination', 'description': 'Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that received at least 1 vaccination and had available data for endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women 16-26 Years of Age', 'description': 'Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'Women 27-45 Years of Age', 'description': 'Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}], 'classes': [{'title': 'Anti HPV 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.8', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '99.2', 'upperLimit': '100.0'}]}]}, {'title': 'Anti HPV 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '99.8', 'groupId': 'OG001', 'lowerLimit': '98.8', 'upperLimit': '100.0'}]}]}, {'title': 'Anti HPV 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '99.2', 'upperLimit': '100.0'}]}]}, {'title': 'Anti HPV 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG001', 'lowerLimit': '98.5', 'upperLimit': '99.9'}]}]}, {'title': 'Anti HPV 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '488', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.2', 'upperLimit': '100.0'}, {'value': '99.8', 'groupId': 'OG001', 'lowerLimit': '98.9', 'upperLimit': '100.0'}]}]}, {'title': 'Anti HPV 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '493', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.2', 'upperLimit': '100.0'}, {'value': '99.8', 'groupId': 'OG001', 'lowerLimit': '98.9', 'upperLimit': '100.0'}]}]}, {'title': 'Anti HPV 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '99.9'}, {'value': '99.2', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '99.8'}]}]}, {'title': 'Anti HPV 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '99.3', 'upperLimit': '100.0'}]}]}, {'title': 'Anti HPV 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.2', 'upperLimit': '100.0'}, {'value': '99.8', 'groupId': 'OG001', 'lowerLimit': '98.8', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks post vaccination 3 (Month 7)', 'description': 'Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Women 16-26 Years of Age', 'description': 'Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}, {'id': 'FG001', 'title': 'Women 27-45 Years of Age', 'description': 'Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '570'}, {'groupId': 'FG001', 'numSubjects': '642'}]}, {'type': 'Vaccination 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '570'}, {'groupId': 'FG001', 'numSubjects': '640'}]}, {'type': 'Vaccination 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '563'}, {'groupId': 'FG001', 'numSubjects': '635'}]}, {'type': 'Vaccination 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '556'}, {'groupId': 'FG001', 'numSubjects': '629'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '553'}, {'groupId': 'FG001', 'numSubjects': '626'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Status unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '570', 'groupId': 'BG000'}, {'value': '642', 'groupId': 'BG001'}, {'value': '1212', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Women 16-26 Years of Age', 'description': 'Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}, {'id': 'BG001', 'title': 'Women 27-45 Years of Age', 'description': 'Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '29.1', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '570', 'groupId': 'BG000'}, {'value': '642', 'groupId': 'BG001'}, {'value': '1212', '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': 'Hispanic', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic', 'measurements': [{'value': '548', 'groupId': 'BG000'}, {'value': '634', 'groupId': 'BG001'}, {'value': '1182', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '539', 'groupId': 'BG000'}, {'value': '627', 'groupId': 'BG001'}, {'value': '1166', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-15', 'size': 2226334, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-04T16:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2017-05-16', 'resultsFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-04', 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type', 'timeFrame': '4 weeks post vaccination 3 (Month 7)', 'description': 'Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants That Experienced at Least 1 Adverse Event (AE)', 'timeFrame': 'Up to 1 month post vaccination 3 (up to 7 months)', 'description': "An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed."}, {'measure': 'Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.', 'timeFrame': 'Up to 1 month post vaccination 3 (up to 7 months)', 'description': "An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed."}, {'measure': 'Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event', 'timeFrame': 'Up to 5 days post any vaccination', 'description': 'Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.'}, {'measure': 'Percentage of Participants That Reported at Least 1 Systemic Adverse Event', 'timeFrame': 'Up to 15 days post any vaccination', 'description': 'An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed'}, {'measure': 'Percentage of Participants With Elevated Temperature (Fever)', 'timeFrame': 'Up to 5 days post any vaccination', 'description': 'Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.'}, {'measure': 'Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types', 'timeFrame': '4 weeks post vaccination 3 (Month 7)', 'description': 'Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Vulvar Cancer', 'Vaginal Cancer', 'Genital Warts', 'Human Papillomavirus Infection']}, 'referencesModule': {'references': [{'pmid': '33676783', 'type': 'DERIVED', 'citation': 'Joura EA, Ulied A, Vandermeulen C, Rua Figueroa M, Seppa I, Hernandez Aguado JJ, Ahonen A, Reich O, Virta M, Perino A, Peris Tuser M, Peters K, Origoni M, Raspagliesi F, Tjalma WAA, Tummers P, Woelber L, Nieminen P, van Damme P, Sehouli J, Fiol Ruiz G, Brucker S, Fehm T, Cheon K, Rawat S, Luxembourg A, Wittke F. Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study. Vaccine. 2021 May 12;39(20):2800-2809. doi: 10.1016/j.vaccine.2021.01.074. Epub 2021 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good physical health\n\nExclusion Criteria:\n\n* history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results\n* history of HPV-related condition\n* history of known prior vaccination with an HPV vaccine\n* pregnant\n* user of recreational or illicit drugs\n* history of severe allergic reaction, including known allergy to any vaccine component\n* immunocompromised\n* history of certain medications or is currently taking or has taken certain medications (details will be discussed at the time of consent)\n* has thrombocytopenia or other coagulation disorder\n* concurrently enrolled in a clinical study of investigational agent'}, 'identificationModule': {'nctId': 'NCT03158220', 'briefTitle': 'Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16 to 26 Year Olds)', 'orgStudyIdInfo': {'id': 'V503-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adult Women 27- to 45-years Old', 'description': 'Adult women 27- to 45-years old will receive V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.', 'interventionNames': ['Biological: V503']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Young Adult Women 16- to 26-years Old', 'description': 'Young adult women 16- to 26-years old will receive V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.', 'interventionNames': ['Biological: V503']}], 'interventions': [{'name': 'V503', 'type': 'BIOLOGICAL', 'otherNames': ['GARDASIL®9 (HPV 9-valent vaccine [recombinant, adsorbed]); HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58'], 'description': 'V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6', 'armGroupLabels': ['Adult Women 27- to 45-years Old', 'Young Adult Women 16- to 26-years Old']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002)', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Klin. 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