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A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine co-administered with GlaxoSmithKline Biologica...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-004347-30

A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine co-administered with GlaxoSmithKline Biologicals’ inactivated hepatitis A and hepatitis B vaccine adsorbed (Twinrix® Paediatric) in healthy female subjects aged 9–15 years

Femme Homme

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Extrait

•To demonstrate non-inferiority of the hepatitis A immune response when HAB is co-administered with HPV-16/18 vaccine at Month 0, 1 and 6 compared to when HAB is administered alone at Month 0, 1 and 6. •To demonstrate non-inferiority of the hepatitis B immune response in terms of proportion of subjects who are seroprotected for anti-HBs at Month 7 when HAB is co-administered with HPV-16/18 vaccine at Month 0, 1 and 6 compared to when HAB is administered alone at Month 0, 1 and 6. • To demonstrate non-inferiority of the HPV-16/18 immune response at Month 7 when the HPV-16/18 vaccine is co-administered with HAB compared to when the HPV-16/18 vaccine is administered alone.

Critère d'inclusion

  • For active immunization of females from the age of 10 years onwards for the prevention of cervical cancer by protecting against incident and 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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