Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

Phase 2

Completed

• Conditions: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection

• Registration Number: NCT00520598
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-22
• Study First Posted: 2007-08-24
• Study Start: 2007-10
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-25
• Last Update Posted: 2015-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 511

Inclusion Criteria

• Female between 16 to 26 years old
• Has never had Pap testing or have only had normal Pap test results
• Lifetime history of 0 to 4 sexual partners

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Exclusion Criteria

• History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
• History of severe allergic reaction that required medical attention
• Are pregnant
• Received a marketed HPV vaccine
• Currently enrolled in a clinical trial
• Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen	4 weeks post dose 3

Secondary Outcome Measures

Name	Time	Method
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen	4 weeks post dose 2