Mobile

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...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-002777-32

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

Femme Homme

  • | Pays :
    • -
  • | Organes :
    • -
  • | Spécialités :
    • -

Extrait

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.

Critère d'inclusion

  • 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

Liens