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

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00551187

Collaborator

(none)

620

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection	Biological: V504 Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Biological: Comparator: Placebo (unspecified)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

620 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine	Biological: V504 V504 0.5 ml injection in 3 dose regimen for 6 month treatment period. 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.
Placebo Comparator: 2 Placebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine	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. Biological: Comparator: Placebo (unspecified) V504 Placebo in 3 dose regimen for 6 month treatment period.

Arm

Intervention/Treatment

Experimental: 1

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

Biological: V504

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

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.

Placebo Comparator: 2

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

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.

Biological: Comparator: Placebo (unspecified)

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

Outcome Measures

Primary Outcome Measures

Geometric mean titers (GMTs) to HPV types contained in the administered vaccines [4 weeks post dose 3]

Secondary Outcome Measures

Seroconversion percentages to HPV types contained in the administered vaccines [4 weeks post dose 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 26 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)