V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: HPV Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00378560

V501-027

2006_032

Details and patient eligibility

About

A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women

Enrollment: 1,021 patients

Sex: Female

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female Subject Aged 18 To 26 Years
• With 1-4 Lifetime Sexual Partners

Exclusion criteria

• Male Subject

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,021 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Comparator: Placebo

2

Experimental group

Description:

Vaccine

Treatment:

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