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

Merck Sharp & Dohme (MSD) logo

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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