Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT00572832
Status:
COMPLETED
Last Update Posted:
2010-08-17
First Post:
2007-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'zimmer@pitt.edu', 'phone': '412-383-2354', 'title': 'Richard Zimmerman', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'One participant in the Standard group did not respond to any of the vaccine HPV types. Eleven participants in the Alternate group either did not receive Dose 3 or were out of window, compared with only one participant in the Standard group.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '6 Month Standard Schedule', 'description': 'Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.', 'otherNumAtRisk': 100, 'otherNumAffected': 57, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '12 Month Alternative Group', 'description': '12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months', 'otherNumAtRisk': 100, 'otherNumAffected': 55, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Soreness at the injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 114, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 95, 'numAffected': 55}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Standard terminology'}, {'term': 'syncope', 'notes': 'One case of brief syncope in 6 month arm resolved without consequence.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 Month Standard Schedule', 'description': 'Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.'}, {'id': 'OG001', 'title': '12 Month Alternative Group', 'description': '12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months'}], 'classes': [{'title': 'Type 6', 'categories': [{'measurements': [{'value': '1894', 'groupId': 'OG000', 'lowerLimit': '1564', 'upperLimit': '2194'}, {'value': '4221', 'groupId': 'OG001', 'lowerLimit': '2930', 'upperLimit': '5416'}]}]}, {'title': 'Type 11', 'categories': [{'measurements': [{'value': '1773', 'groupId': 'OG000', 'lowerLimit': '1261', 'upperLimit': '2252'}, {'value': '5623', 'groupId': 'OG001', 'lowerLimit': '3939', 'upperLimit': '7208'}]}]}, {'title': 'Type 16', 'categories': [{'measurements': [{'value': '5534', 'groupId': 'OG000', 'lowerLimit': '3875', 'upperLimit': '7093'}, {'value': '11832', 'groupId': 'OG001', 'lowerLimit': '8165', 'upperLimit': '15223'}]}]}, {'title': 'Type 18', 'categories': [{'measurements': [{'value': '1225', 'groupId': 'OG000', 'lowerLimit': '1038', 'upperLimit': '1396'}, {'value': '2052', 'groupId': 'OG001', 'lowerLimit': '1138', 'upperLimit': '2959'}]}]}], 'analyses': [{'pValue': '.025', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Non-inferiority was tested against a one-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type. Results: GMT ratios were 2.23, 3,17, 2.14, and 1.68 for types 6,11,16,\\& 18.', 'groupDescription': 'Non-inferiority tested against 1-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Log transformed the data and calculated GMTs. Tested if post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type', 'testedNonInferiority': True, 'nonInferiorityComment': 'The formula used for calculating sample size for the treatment arm (NT) is NT = (1 + 1/u) (Zα + Zβ)2 σ2 /\\[log (RGMC) -δ0\\] where u is the ratio of the size of the control and treatment arms, one sided alpha that is divided by 4, a non-inferiority margin (δ0 of natural log 0.5), the expected ratio of geometric mean concentrations RGMC set at 0.8, and a standard deviation of 1.26 (the largest for HPV-16). The calculated sample size for a power of 80% was 75 participants in each arm.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)', 'description': 'Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.', 'unitOfMeasure': 'milliMerck units per mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was by intention to treat. Participants who had positive baseline antibody titers were excluded from further analyses only for the type(s) for which they were seropositive.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '6 Month Standard Schedule', 'description': 'Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.'}, {'id': 'FG001', 'title': '12 Month Alternative Group', 'description': '12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Two hundred young women from the university community who met the eligibility criteria were recruited at the Student Health Service.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '6 Month Standard Schedule', 'description': 'Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.'}, {'id': 'BG001', 'title': '12 Month Alternative Group', 'description': '12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.3', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '20.1', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '20.2', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24.2', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '24.3', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-11', 'studyFirstSubmitDate': '2007-12-11', 'resultsFirstSubmitDate': '2009-09-03', 'studyFirstSubmitQcDate': '2007-12-12', 'lastUpdatePostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-11', 'studyFirstPostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule', 'timeFrame': '1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)', 'description': 'Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Human Papillomavirus Vaccine'], 'conditions': ['Human Papillomavirus Infection']}, 'referencesModule': {'references': [{'pmid': '20629576', 'type': 'RESULT', 'citation': 'Zimmerman RK, Nowalk MP, Lin CJ, Fox DE, Ko FS, Wettick E, Cost G, Hand L, Hayes J, Michaels M. Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women. J Womens Health (Larchmt). 2010 Aug;19(8):1441-7. doi: 10.1089/jwh.2009.1753.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, open label trial of HPV (human papilloma virus) vaccine, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either vaccine at 6 months or vaccine at 12 months.\n\nBlood will be drawn for titers twice from all participants: pre-dose 1 and one month post third dose. We hypothesize that the GMTs in the test group (T) are non-inferior to the usual timing control group (C):\n\nH0: δ ≤ -δ0 versus H1: δ \\> -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin.', 'detailedDescription': 'The recommendations for HPV vaccine include catch-up of women 18 to 26 years old. Given that a large percentage of women in this age group are attending college, a good place to access them would be through the student health services on college campuses. However, the HPV vaccine schedule of 0, 2, and 6 months is likely to be difficult to implement in a college calendar year and the immunogenicity of alternative schedules is unknown. If the immunogenicity of an altered schedule is good, then higher vaccination rates may be achievable.\n\nAims:\n\n1. Determine if delay in the third dose is immunologically non-inferior to the standard administration schedule (1 month post-dose 3).\n2. Determine the side effect profile of a delayed third dose, in comparison to the standard schedule'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '23 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-23 year old college females who are planning to return to the university for the next fall semester.\n\nExclusion Criteria:\n\n* Pregnancy or planned pregnancy.\n* Prior receipt of HPV vaccine.\n* Greater than four lifetime sexual partners.\n* Immunosuppression.\n* Anti-coagulant therapy.\n* Breastfeeding.\n* History of abnormal pap smear.\n* Allergy to vaccine components.'}, 'identificationModule': {'nctId': 'NCT00572832', 'briefTitle': 'Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting', 'orgStudyIdInfo': {'id': '32090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '6 mon. 3rd dose of quadrivalent human papillomavirus vaccine', 'description': 'Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.', 'interventionNames': ['Biological: Quadrivalent human papillomavirus vaccine on-time administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': '12 mon. 3rd dose of quadrivalent human papillomavirus vaccine', 'description': 'Receipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months.', 'interventionNames': ['Biological: Quadrivalent human papillomavirus vaccine delayed administration']}], 'interventions': [{'name': 'Quadrivalent human papillomavirus vaccine on-time administration', 'type': 'BIOLOGICAL', 'otherNames': ['Gardasil'], 'description': 'The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.', 'armGroupLabels': ['6 mon. 3rd dose of quadrivalent human papillomavirus vaccine']}, {'name': 'Quadrivalent human papillomavirus vaccine delayed administration', 'type': 'BIOLOGICAL', 'otherNames': ['Gardasil'], 'description': 'The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.', 'armGroupLabels': ['12 mon. 3rd dose of quadrivalent human papillomavirus vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Richard K. Zimmerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Richard K. Zimmerman, MD/Principal Investigator', 'oldOrganization': 'University of Pittsburgh'}}}}