Extract

To demonstrate that the immunogenicity of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered according to an alternative schedule of 0, 1, 12 months is non-inferior to that of the vaccine administered according to a standard schedule of 0, 1, 6 months one month after the third dose. The following criteria for non-inferiority will be assessed sequentially: •Non-inferiority with respect to seroconversion will be demonstrated if, one month after the third dose, for both antigens, the upper limit of the 95% CI (confidence interval) for the difference (standard schedule minus alternative schedule) is below 5%. •Non-inferiority with respect to GMT will be demonstrated if, one month after the third dose, for both antigens, the upper limit of 95% CI for the GMT ratio (standard schedule divided by alternative schedule) is below 1.5.

Inclusion criteria

• For active immunization of females from the age of 10 years onwards to prevent incident and persistent infections, cytological abnormalities and cervical neoplasia (CIN), CIN 1 and pre-cancerous lesions (CIN 2 and CIN 3), caused by oncogenic human papillomavirus (HPV) types 16 and 18

Links

• ictrp
• euctr
• euctr