Extrait

Safety •To assess the safety, reactogenicity and occurrence of clinically relevant abnormalities in biochemistry and haematology parameters after administration of the HPV-16/18 L1 VLP AS04 vaccine according to a 2-dose schedule at 0, 6 months in 4-6 year old females, up to one month after the last dose (Month 7). Immunogenicity •To evaluate the immunogenicity (as determined by enzyme-linked immunosorbent assay [ELISA]) of the HPV-16/18 L1 VLP AS04 vaccine administered according to a 2-dose schedule at 0, 6 months in 4-6 year old females, one month after the last dose (Month 7).

Critère d'inclusion

• Healthy Volunteers