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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00157950
First received: September 7, 2005
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Papillomavirus Infections
Biological: Gardasil™
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Who Seroconvert to HPV 6. [ Time Frame: Week 4 Postdose 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Overall study including 14 calendar days after the last vaccination visit. ] [ Designated as safety issue: No ]
    Number of participants who reported 1 or more adverse experience.


Enrollment: 176
Study Start Date: November 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gardasil™
Gardasil™ 3 dose regimen
Biological: Gardasil™
Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
Other Name: V501
Placebo Comparator: Placebo
Gardasil™ matching placebo 3 dose regimen
Biological: Placebo
Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)

  Eligibility

Ages Eligible for Study:   9 Years to 23 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157950

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00157950     History of Changes
Other Study ID Numbers: V501-023, 2005_066
Study First Received: September 7, 2005
Results First Received: August 17, 2010
Last Updated: November 18, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Merck Sharp & Dohme Corp.:
Human Papilloma Virus

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014