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Immunogenicity and safety study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with GSK Biologicals’ seasonal influenza vaccine GSK2321138A in adults aged 50 years and olde...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-000372-15

Immunogenicity and safety study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with GSK Biologicals’ seasonal influenza vaccine GSK2321138A in adults aged 50 years and older

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Extrait

To evaluate the vaccine response rate (VRR) to the HZ/su vaccine (based on the humoral immune response) one month after the last vaccine dose in the HZ/su-FLU-D-QIV co-administration group. To demonstrate non-inferiority in terms of humoral immune response of two doses of the HZ/su vaccine when FLU-D-QIV vaccine is co-administered with the first HZ/su vaccine dose compared to two doses of HZ/su vaccine given alone, one month after the last vaccine dose. To demonstrate non-inferiority (in terms of HI antibody Geometric mean titres(GMTs)) of one dose of FLU-D-QIV vaccine when co-administered with the first HZ/su vaccine dose compared to one dose of FLU-D-QIV vaccine given alone, for the four strains included in FLU-D-QIV vaccine, at Day 21 post vaccination.

Critère d'inclusion

  • Healthy volunteers (Prevention of Herpes Zoster [HZ] and related complications in adults ≥ 50 years of age [YOA ] and immunocompromised adults ≥ 18 YOA.)

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