Extrait

•To demonstrate the non-inferiority of HPV immune response at one month post-dose 3 in Chinese female subjects aged 9-17 years from the current study versus Chinese women aged 18-25 years enrolled in the HPV-039 study (eTrack No. 107638). Criteria for non-inferiority (one month after the third vaccine dose): -The objective will be reached if for each HPV antigen (anti-HPV-16 and anti-HPV-18), the upper limit of the 95% confidence interval (CI) for the GMT ratio [GMTs in subjects aged 18-25 years with immunogenicity results at Month 7 who receive HPV-16/18 L1 VLP AS04 vaccine in the HPV-039 study divided by the GMTs of subjects aged 9-17 years who receive HPV-16/18 L1 VLP AS04 vaccine in the HPV-058 study] is below 2. -This objective will be evaluated in the according-to-protocol (ATP) cohort for immunogenicity

Critère d'inclusion

• Healthy Volunteers