At a glance
ClinicalIndex Comparison Record- ✓Female aged 15-25 years at first vaccination
- ✓Negative urine pregnancy test required
- ✓No more than 6 lifetime sexual partners prior to enrollment
- ✓Intact cervix
- ✕Pregnant or breastfeeding; must be ≥3 months post-pregnancy and not breastfeeding
- ✕Planning pregnancy or discontinuing contraception during first 9 months of study
- ✕Prior HPV vaccination
- ✕History of Hepatitis A vaccination or disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.
In Brief
A Phase 3 clinical trial evaluating Cervarix™ and Havrix™-based investigational formulation for Infections, Papillomavirus. Completed, enrolled 18,729 participants across 138 sites in 14 countries.
Detailed Summary
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Timeline
Interventions
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses