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Completed

NCT Number: NCT00157950

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

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

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Key information

Conditions

Papillomavirus Infections Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

9 year–23 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gardasil™

Biological

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

Other names: V501

Placebo

Biological

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

Primary outcomes

  1. Number of Participants Who Seroconvert to HPV 6.

    Time frame: Week 4 Postdose 3

    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.

  2. Number of Participants Who Seroconvert to HPV 11.

    Time frame: Week 4 Postdose 3

    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.

  3. Number of Participants Who Seroconvert to HPV 16.

    Time frame: Week 4 Postdose 3

    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.

  4. Number of Participants Who Seroconvert to HPV 18.

    Time frame: Week 4 Postdose 3

    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.

Secondary outcomes

  1. Number of Participants With Adverse Experiences

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

    Number of participants who reported 1 or more adverse experience.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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