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

Phase 3CompletedNCT00157950

Merck Sharp & Dohme LLC176 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

176

Conditions

Papillomavirus Infections

Interventions

Gardasil™BIOLOGICAL

Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)

PlaceboBIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 9 YearsMax age: 23 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Week 4 Postdose 3

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.

Time frame: Week 4 Postdose 3

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.

Time frame: Week 4 Postdose 3

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.

Time frame: Week 4 Postdose 3

Secondary Outcomes

Number of Participants With Adverse Experiences

Number of participants who reported 1 or more adverse experience.

Time frame: Overall study including 14 calendar days after the last vaccination visit.

Data from ClinicalTrials.gov

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