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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

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

Treatments: Biological: V504; Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine; Biological: Comparator: Placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551187

2007_566

V504-001

Details and patient eligibility

About

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

Enrollment: 620 patients

Sex: Female

Ages: 16 to 26 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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620 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

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

Biological: V504

2

Placebo Comparator group

Description:

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

Treatment:

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

Biological: Comparator: Placebo (unspecified)