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
24 Years
45 Years
Female
Healthy, Papillomavirus Infection
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome 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
Outcome Description:
HPV 6/11/16/18: The four types of HPV (types 6/11/16/18) were determined by polymerase chain reaction (PCR) testing
Outcome Time Frame:
Base Study: through Month 48
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
V501-019
NCT ID:
NCT00090220
Start Date:
June 2004
Completion Date:
April 2016
Related Keywords:
- Healthy
- Papillomavirus Infection
- Papillomavirus Infections
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