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Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)

Primary Purpose

Papillomavirus Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gardasil™
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Papillomavirus Infections focused on measuring Human Papilloma Virus

Eligibility Criteria

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

Inclusion Criteria: Girls ages 9 to 15 years (must not yet have had coitarche) Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners) Exclusion Criteria: All Subjects: History of known prior vaccination with an HPV vaccine. Women Ages 16 to 23 Only: Individuals with any prior history of genital warts or treatment for genital warts. Individuals with > 3 lifetime male or female sexual partners.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Gardasil™

    Placebo

    Arm Description

    Gardasil™ 3 dose regimen

    Gardasil™ matching placebo 3 dose regimen

    Outcomes

    Primary Outcome Measures

    Number of Participants Who Seroconvert to HPV 6.
    Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
    Number of Participants Who Seroconvert to HPV 11.
    Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.
    Number of Participants Who Seroconvert to HPV 16.
    Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
    Number of Participants Who Seroconvert to HPV 18.
    Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.

    Secondary Outcome Measures

    Number of Participants With Adverse Experiences
    Number of participants who reported 1 or more adverse experience.

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    January 7, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00157950
    Brief Title
    Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
    Official Title
    An Immunogenicity and Safety Study of Gardasil (V501 (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)) in Females 9 to 23 Years of Age in Korea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (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
    This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Papillomavirus Infections
    Keywords
    Human Papilloma Virus

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Gardasil™
    Arm Type
    Experimental
    Arm Description
    Gardasil™ 3 dose regimen
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Gardasil™ matching placebo 3 dose regimen
    Intervention Type
    Biological
    Intervention Name(s)
    Gardasil™
    Other Intervention Name(s)
    V501
    Intervention Description
    Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
    Primary Outcome Measure Information:
    Title
    Number of Participants Who Seroconvert to HPV 6.
    Description
    Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
    Time Frame
    Week 4 Postdose 3
    Title
    Number of Participants Who Seroconvert to HPV 11.
    Description
    Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.
    Time Frame
    Week 4 Postdose 3
    Title
    Number of Participants Who Seroconvert to HPV 16.
    Description
    Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
    Time Frame
    Week 4 Postdose 3
    Title
    Number of Participants Who Seroconvert to HPV 18.
    Description
    Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.
    Time Frame
    Week 4 Postdose 3
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Adverse Experiences
    Description
    Number of participants who reported 1 or more adverse experience.
    Time Frame
    Overall study including 14 calendar days after the last vaccination visit.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    23 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Girls ages 9 to 15 years (must not yet have had coitarche) Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners) Exclusion Criteria: All Subjects: History of known prior vaccination with an HPV vaccine. Women Ages 16 to 23 Only: Individuals with any prior history of genital warts or treatment for genital warts. Individuals with > 3 lifetime male or female sexual partners.
    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
    17986242
    Citation
    Kang S, Kim KH, Kim YT, Kim YT, Kim JH, Song YS, Shin SH, Ryu HS, Han JW, Kang JH, Park SY. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1013-9. doi: 10.1111/j.1525-1438.2007.01123.x. Epub 2007 Nov 6.
    Results Reference
    background
    PubMed Identifier
    26930146
    Citation
    Hurt L, Nsouli-Maktabi H, Rohrbeck P, Clark LL. Use of quadrivalent human papillomavirus vaccine and the prevalence of antibodies to vaccine-targeted strains among female service members before and after vaccination. MSMR. 2016 Feb;23(2):6-13.
    Results Reference
    derived

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    Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)

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