Study to evaluate immunogenicity and safety study of GSK Biologicals’ Herpes Zoster (HZ) vaccine GSK1437173A when co-administered with Pneumovax 23 in adults aged 50 years and older

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-005314-19

Femme et Homme

  • | Pays :
  • -
  • | Organes :
  • -
  • | Spécialités :
  • -

Extrait

To determine the vaccine response rate (VRR) to the HZ/su vaccine (based on humoral immune response) one month after the last vaccine dose in the HZ/su – Pneumovax 23 co-administration (Co-Ad) group. To demonstrate non-inferiority of the humoral immune response to two doses of the HZ/su vaccine when Pneumovax 23 is co-administered with the first HZ/su vaccine dose compared to two doses of HZ/su vaccine (administered separately from Pneumovax 23), one month after the last vaccine dose. To demonstrate non-inferiority of the humoral immune response to Pneumovax 23 when co-administered with HZ/su vaccine at first vaccine dose compared to Pneumovax 23 (administered separately from HZ/su), for the following 12 serotypes included in Pneumovax 23, one month after the vaccine dose: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.


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.)

Liens