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

Phase 3

Completed

• Conditions: Papillomavirus Infections
• Interventions: Biological: Gardasil™; Biological: Placebo

• Registration Number: NCT00157950
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Study Start: 2005-10
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Results First Submitted: 2010-08-17
• Results First Submitted QC: 2010-08-17
• Results First Posted: 2010-09-14
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gardasil™	Gardasil™	Gardasil™ 3 dose regimen
Placebo	Placebo	Gardasil™ matching placebo 3 dose regimen

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Seroconvert to HPV 18.	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.
Number of Participants Who Seroconvert to HPV 6.	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.
Number of Participants Who Seroconvert to HPV 16.	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.
Number of Participants Who Seroconvert to HPV 11.	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Experiences	Overall study including 14 calendar days after the last vaccination visit.	Number of participants who reported 1 or more adverse experience.