Evaluation of the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV vaccine 580299 when administered in healthy females aged 9 - 25 years using an alternative schedule and an alternative dosing as compared to the standard schedule and dosing

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Extract

To evaluate the immunogenicity of the HPV-16/18 L1 VLP AS04 vaccine one month after the last dose when administered at different dosages (20 or 40 µg of each HPV antigen) and on different schedules (0, 2- or 0, 6-months) compared with the standard HPV-16/18 L1 VLP AS04 vaccine administered on a 3-dose schedule (0, 1, 6-months). To evaluate the reactogenicity of the HPV-16/18 L1 VLP AS04 vaccine when administered at different dosages (20 or 40 µg of each HPV type) and on different schedules (0, 2- or 0, 6-months) with respect to the occurrence, intensity and relationship to vaccination of solicited local and general symptoms reported within 7 days (Days 0 - 6) after each and any vaccination.

Inclusion criteria

For active immunization of females for the prevention of cervical cancer by protecting against persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US), cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions (CIN 2/3) caused by oncogenic human papillomavirus (HPV) types 16 and 18

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Evaluation of the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV vaccine 580299 when administered in healthy females aged 9 - 25 years using an alternative schedule and an alternative d...