Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine Administered Intramuscularly ( 0, 1, 6 Month Schedule) in Healthy Women From Malaysia.
The protocol was primarily amended for the following reasons:
- Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming
commercially available in an increasing number of countries. Therefore, the study
procedures were revised to include questions at every visit to determine if subjects
have received an HPV vaccine outside of the study.
- It was decided to offer GSK Biologicals' HPV vaccine to all subjects in the control
group at the end of the study. The HPV vaccine will be offered to these subjects based
on its local indication once the vaccine is marketed in Malaysia.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
At Month 7
GSK Clinical Trials
Malaysia: Ministry of Health