Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-03-10 @ 12:22 AM
Study NCT ID:
NCT02009800
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICI-VPH: Impact of HPV Immunisation Schedules Against HPV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3364}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of persistent HPV-16/18 infections', 'timeFrame': '5 years after recruitment visite'}], 'secondaryOutcomes': [{'measure': 'Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18', 'timeFrame': '5 years after recruitment visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Human Papillomavirus Infections']}, 'referencesModule': {'references': [{'pmid': '41276263', 'type': 'DERIVED', 'citation': 'Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.'}, {'pmid': '40627355', 'type': 'DERIVED', 'citation': 'Sauvageau C, Mayrand MH, Ouakki M, Ionescu IG, Coutlee F, Lacaille J, Benoit M, Gilca V. Protection Against Persistent HPV-16/18 Infection After Different Number of Doses of Quadrivalent Vaccine in Girls and Young Women: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519095. doi: 10.1001/jamanetworkopen.2025.19095.'}]}, 'descriptionModule': {'briefSummary': 'This randomised clinical trial aims to determine whether an immunization schedule comprising two doses of Gardasil administered six months apart is non-inferior to a schedule comprising three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18 infections that persist for at least six months, up to ten years after the initial vaccination.\n\nThe study hypothesis is that the two-dose schedule would offer similar protection as that of a three-dose schedule against persistent HPV-16/18 infections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having received two doses of Gardasil in 2008-2009, 2009-2010,2010-2011 or 2011-2012 according to 0, 6 months Schedule (between 4 and 12 months)\n* Resident of the regions chosen for the study\n\nExclusion Criteria:\n\n* Being considered immunosuppressed at time of vaccination (9-10 years-old) or at recruitment visit\n* Being pregnant at recruitment visit'}, 'identificationModule': {'nctId': 'NCT02009800', 'acronym': 'ICI-VPH', 'briefTitle': 'ICI-VPH: Impact of HPV Immunisation Schedules Against HPV', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': "ICI-VPH: Impact Des Calendriers d'Immunisation Contre Les HPV", 'orgStudyIdInfo': {'id': 'ICI-VPH-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '2 dose of quadrivalent HPV vaccine', 'description': 'The participants who have already received 2 doses of the quadrivalent HPV vaccine (0, 6 months schedule) 5 years before recruitment will not receive an additional dose.'}, {'type': 'EXPERIMENTAL', 'label': '3 doses of quadrivalent HPV vaccine', 'description': 'The participants will receive a 3rd dose of quadrivalent HPV vaccine at recruitment visit, which is 5 years after having received two doses of vaccine given 6 months apart in grade 4 (0, 6, 60 months Schedule)', 'interventionNames': ['Biological: Quadrivalent HPV vaccine']}], 'interventions': [{'name': 'Quadrivalent HPV vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Gardasil'], 'description': 'One dose of Gardasil administered in the intervention group', 'armGroupLabels': ['3 doses of quadrivalent HPV vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Uiversitaire de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Québec, CHU de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'collaborators': [{'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, {'name': 'Ministere de la Sante et des Services Sociaux', 'class': 'OTHER'}, {'name': 'Institut National en Santé Publique du Québec', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-principal investigator', 'investigatorFullName': 'Chantal Sauvageau', 'investigatorAffiliation': 'CHU de Quebec-Universite Laval'}}}}