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

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

Official Title
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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

Conditions
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Papillomavirus Infections

Intervention / Treatment
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* Biological: Gardasil™
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gardasil™<br>Gardasil™ 3 dose regimen | Biological: Gardasil™<br>* Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)<br>* Other names: V501;|
| Placebo Comparator: Placebo<br>Gardasil™ matching placebo 3 dose regimen | Biological: Placebo<br>* Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Week 4 Postdose 3 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papilloma Virus