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A phase II, observer-blind, randomised, placebo-controlled, adjuvant-dose selection, multicenter prophylactic vaccination study to evaluate the immunogenicity and safety of GSK Biologicals’ herpes zos...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-005120-86

A phase II, observer-blind, randomised, placebo-controlled, adjuvant-dose selection, multicenter prophylactic vaccination study to evaluate the immunogenicity and safety of GSK Biologicals’ herpes zoster vaccine, gE/AS01B, in comparison to gE combined with ½ dose AS01B adjuvant (gE/AS01E), to unadjuvanted gE (gE/Saline), and to Saline (placebo) when administered twice in subjects aged 50 years and older

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Extrait

To compare gE and VZV-specific CD4 T cell-mediated immune (CMI) and humoral immune responses to study vaccines (gE/AS01B, gE/AS01E, and gE/Saline) at Month 3 (one month following vaccinations at Months 0 and 2) in subjects ≥ 50 YOA (overall study population).

Critère d'inclusion

  • Primary immunisation of subjects aged 50 years or older against herpes zoster (HZ),The study population includes healthy volunteer males and females in the age ranges: 50-59 years of age (YOA), 60-69 YOA, and more than 70 YOA

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