Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster (HZ/su) vaccine in adults with solid tumours receiving chemotherapy

Update Il y a 4 ans
Reference: EUCTR2012-002966-11

Woman and Man

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Extract

The study will be randomised into two groups based on the vaccination schedule in relation to the start of a chemotherapy cycle: - The OnChemo group receives their first HZ/su vaccination at the start of a chemotherapy cycle - The PreChemo group receives their first HZ/su vaccination at least 10 days before the start of a chemotherapy cycle •To evaluate anti-gE humoral immune responses at Month 2 (M2), following a two-dose administration of the HZ/su vaccine (post-dose 2), as compared to placebo, in subjects with solid tumours receiving chemotherapy (PreChemo groups only) •To evaluate the safety and reactogenicity following administration of the HZ/su vaccine as compared to placebo up to 30 days post last vaccination in subjects with solid tumours receiving chemotherapy


Inclusion criteria

  • Herpes Zoster and related complications