At a glance
ClinicalIndex Comparison Record- ✓Female aged 15–55 years at first vaccination
- ✓Healthy with no obvious health problems
- ✓Negative urine pregnancy test required
- ✓Non-childbearing or using adequate contraception for 30 days prior and 2 months after vaccination series
- ✕Pregnant or breastfeeding
- ✕Planning to become pregnant or planning to discontinue contraception during study period up to 2 months after last dose
- ✕Any prior HPV vaccination
- ✕Immunodeficient condition based on medical history and physical examination
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up
In Brief
A Phase 3 clinical trial evaluating Cervarix for Infections, Papillomavirus. Completed, enrolled 667 participants across 6 sites in 2 countries.
Detailed Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go 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. This study will evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start. Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule. The study will be extended to assess long-term safety and immunogenicity of the HPV-16/18 vaccine.
Study Details
Timeline
Interventions
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.