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

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-003807-38

A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 AS04 vaccine co-administered with GlaxoSmithKline Biologicals’ combined reduced-antigen diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Boostrix® Polio) in healthy female subjects aged 10–18 years

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Extrait

• To demonstrate non-inferiority of the dTpa-IPV immune response at Month 1 when dTpa-IPV is co-administered with HPV-16/18 L1 AS04 vaccine at Month 0 compared to when dTpa-IPV is administered alone at Month 0.

Critère d'inclusion

  • In female subjects from 10 years of age onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including ASC-US, cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions caused by oncogenic human papillomaviruses (HPV)

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