At a glance
ClinicalIndex Comparison Record- ✓Female aged 18-35 years at first vaccination
- ✓Healthy status established by medical history and clinical examination
- ✓Negative urine pregnancy test required
- ✓Able to comply with protocol requirements per investigator assessment
- ✕Pregnant or breastfeeding
- ✕Planning to become pregnant or likely to become pregnant
- ✕Previous HPV vaccination
- ✕Previous administration of vaccine components
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV-16/18 VLP/AS04 Vaccine Administered Intramuscularly at 0, 1, 6 Months in Healthy Indian Female Subjects Aged 18-35 Yrs
In Brief
A Phase 3 clinical trial evaluating Placebo and HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) for Infections, Papillomavirus. Completed, enrolled 354 participants across 4 sites.
Detailed Summary
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immune response induced by the HPV-16/18 L1/AS04 vaccine and the safety of the vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Timeline
Interventions
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.