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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-06-30

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.

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Detailed Description

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Conditions

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Papillomavirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Gardasil™

Gardasil™ 3 dose regimen

Group Type EXPERIMENTAL

Gardasil™

Intervention Type BIOLOGICAL

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

Placebo

Gardasil™ matching placebo 3 dose regimen

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

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Gardasil™

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Other Intervention Names

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V501

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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

23 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes