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V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

Primary Purpose

HPV Infections

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HPV Infections

Eligibility Criteria

18 Years - 26 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female Subject Aged 18 To 26 Years
  • With 1-4 Lifetime Sexual Partners

Exclusion Criteria:

  • Male Subject

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    Placebo

    Vaccine

    Outcomes

    Primary Outcome Measures

    Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype
    Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.

    Secondary Outcome Measures

    Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)
    Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".
    Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)
    Month 7 HPV cLIA Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".
    Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)
    Month 7 HPV cLIA Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".
    Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)
    Month 7 HPV cLIA Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".

    Full Information

    First Posted
    September 18, 2006
    Last Updated
    March 20, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00378560
    Brief Title
    V501 Efficacy Study in Women Aged 18 to 26 (V501-027)
    Official Title
    V501 Phase II Efficacy Study in Women Aged 18 to 26
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 12, 2006 (Actual)
    Primary Completion Date
    September 16, 2009 (Actual)
    Study Completion Date
    September 16, 2009 (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
    A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HPV Infections

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1021 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Vaccine
    Intervention Type
    Biological
    Intervention Name(s)
    Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Other Intervention Name(s)
    V501, Gardasil
    Intervention Description
    V501; Gardasil, 0.5 ml injection in 3 dosing regimen
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo 0.5 ml injection in 3 dosing regimen
    Primary Outcome Measure Information:
    Title
    Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype
    Description
    Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.
    Time Frame
    Over 30 months
    Secondary Outcome Measure Information:
    Title
    Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)
    Description
    Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".
    Time Frame
    At one month after completed vaccination series (Month 7)
    Title
    Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)
    Description
    Month 7 HPV cLIA Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".
    Time Frame
    At one month after completed vaccination series (Month 7)
    Title
    Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)
    Description
    Month 7 HPV cLIA Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".
    Time Frame
    At one month after completed vaccination series (Month 7)
    Title
    Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)
    Description
    Month 7 HPV cLIA Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".
    Time Frame
    At one month after completed vaccination series (Month 7)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    26 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female Subject Aged 18 To 26 Years With 1-4 Lifetime Sexual Partners Exclusion Criteria: Male Subject
    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

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    23331518
    Citation
    Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7.
    Results Reference
    result
    PubMed Identifier
    32827835
    Citation
    Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.
    Results Reference
    derived

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    V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

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