Overview

This trial is active, not recruiting.

Conditions healthy, papillomavirus infection
Treatments quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, comparator: placebo
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date June 2004
End date May 2009
Trial size 3819 participants
Trial identifier NCT00090220, 2004_013, V501-019

Summary

This study is to assess the tolerability and efficacy of a vaccine being evaluated to reduce the incidence of human papillomavirus (HPV) infection and disease (external genital warts and vulvar, vaginal, and cervical cancer) in women.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Gardasil
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Gardasil intramuscular injection in three 0.5 mL doses over 6 months.
(Placebo Comparator)
comparator: placebo
Placebo intramuscular injection in three 0.5 mL doses over 6 months.

Primary Outcomes

Measure
Combined Incidence of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, Vulvar Intraepithelial Neoplasia (VIN), Vaginal Intraepithelial Neoplasia (VaIN), Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, AIS, and Cervical Cancer
time frame: Base Study: through Month 48
Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)
time frame: Base Study: through Month 48

Secondary Outcomes

Measure
Combined Incidence of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Adenocarcinoma In Situ (AIS), and Cervical Cancer
time frame: Base Study: through Month 48
Combined Incidence of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer
time frame: Base Study: through Month 48

Eligibility Criteria

Female participants from 24 years up to 45 years old.

Inclusion Criteria: - No history of genital warts, VIN, or VaIN - Not pregnant and agrees to use effective contraception through Month 7 of the study - Additional criteria will be discussed with you by the physician 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 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

Additional Information

Official title 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
Description The base study (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned Gardasil™ (qHPV vaccine) or placebo at Day 1, Month 2 and Month 6. Base study follow-up continued through 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 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 V501-019-20 (EXT2) will observe the long term safety, effectiveness, and immunogenicity of GARDASIL™ in 1,600 women who participated in the base protocol in Colombia. Data will be collected over a period of 6-10 years following subjects' enrollment in the original base protocol.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..