Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-04 @ 9:19 PM
Study NCT ID:
NCT00157950
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2005-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068857', 'term': 'Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18'}], 'ancestors': [{'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D053918', 'term': 'Papillomavirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', '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}}, 'adverseEventsModule': {'timeFrame': 'During the double-blind period including 14 calendar days after the last vaccination visit.', 'description': 'Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.', 'eventGroups': [{'id': 'EG000', 'title': 'Gardasil™', 'description': 'Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)', 'otherNumAtRisk': 117, 'otherNumAffected': 88, 'seriousNumAtRisk': 117, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)', 'otherNumAtRisk': 59, 'otherNumAffected': 41, 'seriousNumAtRisk': 59, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Injection site tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'seriousEvents': [{'term': 'Traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Acute pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Seroconvert to HPV 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gardasil™', 'description': 'Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.2', 'ciLowerLimit': '93.6', 'ciUpperLimit': '99.8', 'estimateComment': 'Exact binomial confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.', 'unitOfMeasure': 'Participants', '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Seroconvert to HPV 11.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gardasil™', 'description': 'Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '96.8', 'ciUpperLimit': '100', 'estimateComment': 'Exact binomial confidence interval', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.', 'unitOfMeasure': 'Participants', '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Seroconvert to HPV 16.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gardasil™', 'description': 'Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.1', 'ciLowerLimit': '95.2', 'ciUpperLimit': '100', 'estimateComment': 'Exact binomial confidence interval', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.', 'unitOfMeasure': 'Participants', '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Seroconvert to HPV 18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gardasil™', 'description': 'Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.1', 'ciLowerLimit': '95.0', 'ciUpperLimit': '100', 'estimateComment': 'Exact binomial confidence interval', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.', 'unitOfMeasure': 'Participants', '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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Experiences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gardasil™', 'description': 'Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)'}], 'classes': [{'title': 'Discontinued due to an Adverse Experience (AE)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to vaccine related AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to an Serious AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to serious vaccine-related AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Overall study including 14 calendar days after the last vaccination visit.', 'description': 'Number of participants who reported 1 or more adverse experience.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of injection.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gardasil™', 'description': 'Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Vaccinated at Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Vaccinated at Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Vaccinated at Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited at 10 medical sites in Korea.\n\nFirst Patient Treated: 20-Oct-2005\n\nLast Patient Treated: 24-Jun-2006', 'preAssignmentDetails': 'A serum or urine pregnancy test was performed prior to each injection on all subjects. Results were available prior to vaccination. Any subject with a positive pregnancy test at Day 1 was not randomized or vaccinated, and was not eligible to continue in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gardasil™', 'description': 'Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Gardasil™ matching placebo 3 dose regimen (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': '16.7', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '16.5', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '16.6', 'spread': '5.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '176', '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': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2005-09-07', 'resultsFirstSubmitDate': '2010-08-17', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-17', 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Seroconvert to HPV 6.', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.'}, {'measure': 'Number of Participants Who Seroconvert to HPV 11.', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.'}, {'measure': 'Number of Participants Who Seroconvert to HPV 16.', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.'}, {'measure': 'Number of Participants Who Seroconvert to HPV 18.', 'timeFrame': 'Week 4 Postdose 3', 'description': 'Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Experiences', 'timeFrame': 'Overall study including 14 calendar days after the last vaccination visit.', 'description': 'Number of participants who reported 1 or more adverse experience.'}]}, 'conditionsModule': {'keywords': ['Human Papilloma Virus'], 'conditions': ['Papillomavirus Infections']}, 'referencesModule': {'references': [{'pmid': '17986242', 'type': 'BACKGROUND', 'citation': 'Kang S, Kim KH, Kim YT, Kim YT, Kim JH, Song YS, Shin SH, Ryu HS, Han JW, Kang JH, Park SY. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1013-9. doi: 10.1111/j.1525-1438.2007.01123.x. Epub 2007 Nov 6.'}, {'pmid': '26930146', 'type': 'DERIVED', 'citation': 'Hurt L, Nsouli-Maktabi H, Rohrbeck P, Clark LL. Use of quadrivalent human papillomavirus vaccine and the prevalence of antibodies to vaccine-targeted strains among female service members before and after vaccination. MSMR. 2016 Feb;23(2):6-13.'}]}, 'descriptionModule': {'briefSummary': 'This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Girls ages 9 to 15 years (must not yet have had coitarche)\n* Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners)\n\nExclusion Criteria:\n\nAll Subjects:\n\n* History of known prior vaccination with an HPV vaccine.\n\nWomen Ages 16 to 23 Only:\n\n* Individuals with any prior history of genital warts or treatment for genital warts.\n* Individuals with \\> 3 lifetime male or female sexual partners.'}, 'identificationModule': {'nctId': 'NCT00157950', 'briefTitle': 'Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Immunogenicity and Safety Study of Gardasil (V501 (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)) in Females 9 to 23 Years of Age in Korea', 'orgStudyIdInfo': {'id': 'V501-023'}, 'secondaryIdInfos': [{'id': '2005_066'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gardasil™', 'description': 'Gardasil™ 3 dose regimen', 'interventionNames': ['Biological: Gardasil™']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Gardasil™ matching placebo 3 dose regimen', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Gardasil™', 'type': 'BIOLOGICAL', 'otherNames': ['V501'], 'description': 'Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)', 'armGroupLabels': ['Gardasil™']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)', 'armGroupLabels': ['Placebo']}]}, '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'}}}}