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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00157950
First received: September 7, 2005
Last updated: November 18, 2010
Last verified: November 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  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:
Human Papilloma Virus

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

ClinicalTrials.gov processed this record on May 22, 2013