At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 25 years
- ✓Resident of Guanacaste Province of Costa Rica and surrounding areas, must remain resident for ≥ 6 months after first study vaccination
- ✓Deemed to be in good general health by history and physical examination
- ✓Able to speak or understand Spanish
- ✕Pregnant, nursing, or delivery within past 3 months; negative pregnancy test required; fertile patients must use effective contraception for 30 days before, during, and 60 days after study treatment
- ✕Prior vaccination against hepatitis A or human papillomavirus
- ✕History of cancer, diabetes, or other chronic conditions requiring treatment
- ✕History of chronic hepatitis requiring treatment, or acute/chronic clinically significant hepatic function abnormality; known history of hepatitis A infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.
In Brief
A Phase 3 clinical trial evaluating human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine and hepatitis A inactivated virus vaccine for Cervical Cancer and Precancerous Condition. Completed, enrolled 7,466 participants across 1 site.
Detailed Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing, or coming back. Vaccines may help the body build an effective immune response against human papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer. PURPOSE: This randomized phase III trial is studying human papillomavirus vaccine to see how well it works compared to hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer in younger healthy participants.
Study Details
Timeline
Interventions
Three doses of Cervarix vaccine administered on a 0, 1, 6-month schedule
Three doses of Havrix vaccine administered on a 0, 1, 6-month schedule