Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED) (FUTURE)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Genital Warts; Cervical Cancer

Treatments: Biological: V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years; Biological: Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517309

V501-011

2007_576

Details and patient eligibility

About

The primary purpose of the study is to test the safety of HPV Vaccine in Women

Enrollment: 1,877 patients

Sex: Female

Ages: 16 to 23 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females age 16 to 23 years old
• Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit

Exclusion criteria

• History of vaccination with an HPV vaccine
• History of hepatitis B infection
• History of vaccination with hepatitis B vaccine
• History of genital warts or treatment for genital warts

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind