A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)

Phase 2

Completed

• Conditions: Genital Warts; Human Papillomavirus Infection; Vaginal Cancer; Cervical Cancer; Vulvar Cancer
• Interventions: Biological: V504

• Registration Number: NCT00551187
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Study First Posted: 2007-10-30
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-05
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 620

Inclusion Criteria

• Females between 16- to 26-years-old
• Has never had Pap testing or has 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 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 the time of consent)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	V504	V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Seroconversion percentages to HPV types contained in the administered vaccines	4 weeks post dose 3