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V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

Primary Purpose

Cervical Cancer, Cervical Intraepithelial Neoplasia, Adenocarcinoma in Situ

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
V501
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

16 Years - 26 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy Japanese females
  • Not pregnant at Screening and agree to use effective contraception through Month 7 of the study
  • Lifetime history of 0 to 4 male or female sexual partners
  • No oral temperature ≥37.5 centigrade within 24 hours prior to injection

Exclusion Criteria:

  • Received a marketed HPV vaccine
  • Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN
  • Known history of positive test for HPV
  • Known history of genital warts
  • Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study
  • History of splenectomy, known immune disorders, or receiving immunosuppressives
  • Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    V501

    Arm Description

    Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6

    Outcomes

    Primary Outcome Measures

    Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18
    The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 29, 2012
    Last Updated
    November 1, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01544478
    Brief Title
    V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
    Official Title
    A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 25, 2011 (Actual)
    Primary Completion Date
    August 27, 2016 (Actual)
    Study Completion Date
    August 27, 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Cervical Intraepithelial Neoplasia, Adenocarcinoma in Situ

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1030 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    V501
    Arm Type
    Experimental
    Arm Description
    Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
    Intervention Type
    Biological
    Intervention Name(s)
    V501
    Other Intervention Name(s)
    Gardasil™
    Intervention Description
    HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6
    Primary Outcome Measure Information:
    Title
    Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18
    Description
    The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.
    Time Frame
    Up to Month 48

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    26 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy Japanese females Not pregnant at Screening and agree to use effective contraception through Month 7 of the study Lifetime history of 0 to 4 male or female sexual partners No oral temperature ≥37.5 centigrade within 24 hours prior to injection Exclusion Criteria: Received a marketed HPV vaccine Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN Known history of positive test for HPV Known history of genital warts Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study History of splenectomy, known immune disorders, or receiving immunosuppressives Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    30879979
    Citation
    Sakamoto M, Miyagi E, Sumi Y, Aisaka K, Kuno N, Nagano H, Asahara S, Han SR, Wakana A, Murata S, Sawata M, Tanaka Y. Effectiveness on high-grade cervical abnormalities and long-term safety of the quadrivalent human papillomavirus vaccine in Japanese women. J Infect Chemother. 2019 Jul;25(7):520-525. doi: 10.1016/j.jiac.2019.02.012. Epub 2019 Mar 15.
    Results Reference
    derived

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    V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

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