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
9 Years
23 Years
Female
Papillomavirus Infections
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Number of Participants Who Seroconvert to HPV 6.
Outcome 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.
Outcome Time Frame:
Week 4 Postdose 3
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
V501-023
NCT ID:
NCT00157950
Start Date:
November 2005
Completion Date:
June 2006
Related Keywords:
- Papillomavirus Infections
- Human Papilloma Virus
- Papillomavirus Infections
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