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Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ meningococcal vaccine with or without co-administration of a licensed viral vaccine and Boostrix in female adolescents and young a...

Update Il y a 4 ans
Reference: EUCTR2012-001876-13

Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ meningococcal vaccine with or without co-administration of a licensed viral vaccine and Boostrix in female adolescents and young adults

Woman Man

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Extract

•To demonstrate non-inferiority of MenACWY-TT co-ad with a viral vaccine compared to MenACWY-TT alone with respect to GMTs for A, C, W-135 and Y. •To demonstrate the non-inferiority of a viral vaccine co-ad with MenACWY-TT compared to a viral vaccine alone in terms of HPV GMTs. •To demonstrate non-inferiority of MenACWY-TT co-ad with a viral vaccine and Boostrix compared to MenACWY-TT alone with respect to GMTs for A, C, W-135 and Y. •To demonstrate non-inferiority of a viral vaccine co-ad with MenACWY-TT and Boostrix compared to a viral vaccine co-administered with Boostrix in terms of HPV GMTs. •To demonstrate non-inferiority of Boostrix co-ad with MenACWY-TT and a viral vaccine compared to Boostrix co-administered with a viral vaccine in terms of anti-D and anti-T concentrations. •To demonstrate non-inferiority of Boostrix co-ad with MenACWY-TT and a viral vaccine compared to Boostrix co-administered with a viral vaccine with respect to GMCs to pertussis antigens.

Inclusion criteria

  • Meningococcal Disease

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