Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: HPV Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00834106

2009_532

V501-041

Details and patient eligibility

About

A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specific genital disease among Chinese females between the ages of 20 and 45.

Full description

The Base Study V501-041 duration was 30 months. The study was extended to further evaluate the efficacy of Quadrivalent HPV (Type 6, 11, 16, 18) L1 VLP (qHPV) vaccine against Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ (AIS), and/or cervical cancer. The efficacy was followed through the Month 78 visit, and the close-out visit was conducted at approximately Month 90 with only safety data collected

Enrollment: 3,006 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy women between the ages of 20 and 45
• Have used effective contraception for 2 weeks prior to starting in the study
• Does not have a temperature within 24 hours before the first injection

Exclusion criteria

• Prior history of genital warts
• More than 4 lifetime sexual partners
• Have undergone hysterectomy
• Have active cervical disease or history of cervical disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,006 participants in 2 patient groups, including a placebo group

qHPV

Experimental group

Description:

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6

Treatment:

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

Placebo

Placebo Comparator group

Description:

Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6

Treatment:

Biological: Comparator: placebo (unspecified)