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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Group Type EXPERIMENTAL

V504

Intervention Type BIOLOGICAL

V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.

Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Intervention Type BIOLOGICAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.

2

Placebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Group Type PLACEBO_COMPARATOR

Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Intervention Type BIOLOGICAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.

Comparator: Placebo (unspecified)

Intervention Type BIOLOGICAL

V504 Placebo in 3 dose regimen for 6 month treatment period.

Interventions

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V504

V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.

Intervention Type BIOLOGICAL

Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.

Intervention Type BIOLOGICAL

Comparator: Placebo (unspecified)

V504 Placebo in 3 dose regimen for 6 month treatment period.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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)

Minimum Eligible Age

16 Years

Maximum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes