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Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

Primary Purpose

Cervical Cancer, Genital Warts

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

16 Years - 23 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female with an intact uterus with lifetime history of 0-4 sexual partners Exclusion Criteria: Prior Human Papillomavirus Vaccine (HPV) vaccination; Prior abnormal paps; Prior history of genital warts

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Tolerability and immune responses at week 4 post dose 3.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 22, 2004
    Last Updated
    March 20, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092482
    Brief Title
    Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)
    Official Title
    Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 28, 2002 (Actual)
    Primary Completion Date
    June 30, 2004 (Actual)
    Study Completion Date
    August 15, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Genital Warts

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    3882 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years
    Primary Outcome Measure Information:
    Title
    Tolerability and immune responses at week 4 post dose 3.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    23 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female with an intact uterus with lifetime history of 0-4 sexual partners Exclusion Criteria: Prior Human Papillomavirus Vaccine (HPV) vaccination; Prior abnormal paps; Prior history of genital warts
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17428949
    Citation
    Garland SM, Steben M, Hernandez-Avila M, Koutsky LA, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Esser MT, Vuocolo SC, Nelson M, Railkar R, Sattler C, Barr E; 012 Study Investigators. Noninferiority of antibody response to human papillomavirus type 16 in subjects vaccinated with monovalent and quadrivalent L1 virus-like particle vaccines. Clin Vaccine Immunol. 2007 Jun;14(6):792-5. doi: 10.1128/CVI.00478-06. Epub 2007 Apr 11.
    Results Reference
    background
    PubMed Identifier
    17955433
    Citation
    Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17.
    Results Reference
    background
    PubMed Identifier
    21307649
    Citation
    Brown DR, Garland SM, Ferris DG, Joura E, Steben M, James M, Radley D, Vuocolo S, Garner EI, Haupt RM, Bryan JT. The humoral response to Gardasil over four years as defined by total IgG and competitive Luminex immunoassay. Hum Vaccin. 2011 Feb;7(2):230-8. doi: 10.4161/hv.7.2.13948. Epub 2011 Feb 1.
    Results Reference
    result
    PubMed Identifier
    35525430
    Citation
    Brown DR, Castellsague X, Ferris D, Garland SM, Huh W, Steben M, Wheeler CM, Saah A, Luxembourg A, Li S, Velicer C. Human papillomavirus seroprevalence and seroconversion following baseline detection of nine human papillomavirus types in young women. Tumour Virus Res. 2022 Jun;13:200236. doi: 10.1016/j.tvr.2022.200236. Epub 2022 May 4.
    Results Reference
    derived
    PubMed Identifier
    32184277
    Citation
    Doshi P, Bourgeois F, Hong K, Jones M, Lee H, Shamseer L, Spence O, Jefferson T. Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology. BMJ Evid Based Med. 2020 Dec;25(6):213-219. doi: 10.1136/bmjebm-2019-111331. Epub 2020 Mar 17.
    Results Reference
    derived
    PubMed Identifier
    21300618
    Citation
    Insinga RP, Perez G, Wheeler CM, Koutsky LA, Garland SM, Leodolter S, Joura EA, Ferris DG, Steben M, Hernandez-Avila M, Brown DR, Elbasha E, Munoz N, Paavonen J, Haupt RM; FUTURE I Investigators. Incident cervical HPV infections in young women: transition probabilities for CIN and infection clearance. Cancer Epidemiol Biomarkers Prev. 2011 Feb;20(2):287-96. doi: 10.1158/1055-9965.EPI-10-0791.
    Results Reference
    derived
    PubMed Identifier
    19505910
    Citation
    Garland SM, Insinga RP, Sings HL, Haupt RM, Joura EA. Human papillomavirus infections and vulvar disease development. Cancer Epidemiol Biomarkers Prev. 2009 Jun;18(6):1777-84. doi: 10.1158/1055-9965.EPI-09-0067.
    Results Reference
    derived
    PubMed Identifier
    19236279
    Citation
    Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, Sings HL, James M, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):926-35. doi: 10.1086/597307.
    Results Reference
    derived
    PubMed Identifier
    19236277
    Citation
    Wheeler CM, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, James M, Vuocolo S, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):936-44. doi: 10.1086/597309.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

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