Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

Phase 3

Completed

• Conditions: Cervical Cancer; Genital Warts

• Registration Number: NCT00517309
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The primary purpose of the study is to test the safety of HPV Vaccine in Women

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2001-12-28
• Primary Completion: 2004-06-08
• Study Completion: 2004-06-11
• Study First Submitted: 2007-08-15
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-16
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1877

Inclusion Criteria

• Females age 16 to 23 years old
• Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit

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Exclusion Criteria

• History of vaccination with an HPV vaccine
• History of hepatitis B infection
• History of vaccination with hepatitis B vaccine
• History of genital warts or treatment for genital warts

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.

Secondary Outcome Measures

Name	Time	Method
HPV vaccine is well tolerated in 16-23 year old females.