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

Overview

This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2006

Interventions

  • Biological: Gardasil™
    • Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
  • Biological: Placebo
    • Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)

Arms, Groups and Cohorts

  • Experimental: Gardasil™
    • Gardasil™ 3 dose regimen
  • Placebo Comparator: Placebo
    • Gardasil™ matching placebo 3 dose regimen

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants Who Seroconvert to HPV 6.
    • Time Frame: Week 4 Postdose 3
    • 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.
    • Time Frame: Week 4 Postdose 3
    • 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.
    • Time Frame: Week 4 Postdose 3
    • 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.
    • Time Frame: Week 4 Postdose 3
    • 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 Measures

  • Number of Participants With Adverse Experiences
    • Time Frame: Overall study including 14 calendar days after the last vaccination visit.
    • Number of participants who reported 1 or more adverse experience.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 9 Years

Maximum Age: 23 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

References

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.

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