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
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
+ Comparator: Placebo
Urogenital Diseases+9
+ Genital Diseases
+ Communicable Diseases
Prevention Study
Summary
Study start date: June 16, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3819 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 24 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives