A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Prevention; Healthy Adult Female Participants; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; Papillomavirus Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090220

2004_013

V501-019

Details and patient eligibility

About

This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.

Full description

The Base study vaccination period (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned, blinded Gardasil™ (V501, qHPV vaccine) or placebo at Day 1, Month 2 and Month 6. The Base study follow-up period continued through approximately Month 48.

The base study was extended in protocol V501-019-10 (EXT1). Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete, open-label, 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

A Long Term Follow-Up (LTFU) extension study V501-019-21 (EXT2) was added to observe the long term safety, effectiveness, and immunogenicity of qHPV vaccine in approximately 1,600 women who participated in the Base Study at sites in Colombia. Data were collected over a period of 6-10 years following participant's enrollment in the original Base Study.

Enrollment: 3,819 patients

Sex: Female

Ages: 24 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN)
• Not pregnant and agrees to use effective contraception through Month 7 of the study
• Additional criteria applied

Exclusion criteria

• Pregnant
• Concurrently enrolled in a clinical study involving collection of cervical specimens
• Previously received any HPV vaccine
• History of severe allergic reaction that required medical intervention
• Received any immune globulin or blood-derived products within 3 months prior to the first study injection
• History of splenectomy, known immune disorders, or receiving immunosuppressives
• Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection
• Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections
• History of recent or ongoing alcohol or drug abuse
• Prior treatment for genital warts, VIN, or VaIN
• History of cervical disease (ie, surgical treatment for cervical lesions)
• Hysterectomy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

3,819 participants in 2 patient groups, including a placebo group

qHPV Vaccine in Base Study

Experimental group

Description:

Participants received blinded qHPV vaccination at Day 1, Month 2, and Month 6 of the Base Study

Treatment:

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

Placebo in Base Study

Placebo Comparator group

Description:

Participants received blinded placebo at Day 1, Month 2, and Month 6 in the Base Study. They were eligible to receive open-label qHPV vaccine in Extension 1

Treatment:

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

Biological: Comparator: Placebo