NCT00090220

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

Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,819 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 24 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine	qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1
BIOLOGICAL	Comparator: Placebo	Placebo intramuscular injection in three 0.5 mL doses over 6 months.

Timeline

• Start date: 2004-06-16
• Primary completion: 2009-05-21
• Completion: 2015-11-12
• First posted: 2004-08-27
• Last updated: 2017-04-21
• Results posted: 2010-02-01