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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Papillomavirus Infections

Treatments: Biological: Gardasil™; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00157950

V501-023

2005_066

Details and patient eligibility

About

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

Enrollment: 176 patients

Sex: Female

Ages: 9 to 23 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 2 patient groups, including a placebo group

Gardasil™

Experimental group

Description:

Gardasil™ 3 dose regimen

Treatment:

Biological: Gardasil™

Placebo

Placebo Comparator group

Description:

Gardasil™ matching placebo 3 dose regimen

Treatment:

Biological: Placebo