Extrait

-To evaluate vaccine response rate (VRR) for anti-glyoprotein E (gE) humoral immune responses at one 1 month (mth) post-dose 2 (PD2) in the 0,6-mth and 0,12-mth schedule groups. *Criterion:The lower limit of the 97,5% confidence interval (CI) of the VRR for anti-gE ELISA antibody concentrations at 1 mth PD2 in the 0,6-mth or 0,12-mth schedule groups is at least 60% If the objectives are met for the 0,6-mth and 0,12-mth schedules, the following objective will be evaluated: -Non-inferiority in terms of anti-gE humoral immune response 1 mth PD2 given according to a 0,6-mth schedule compared to a 0,2-mth schedule and a 0,12-mth schedule compared to a 0,2-mth schedule Criteria for non-inferiority: *The upper limit of the 97,5% CI for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-mth schedule over 0,6-mth schedule) at 1 mth PD2 is <1.5 *The upper limit of the 97,5% CI for the anti-gE ELISA GMC ratio (0,2-mth schedule over 0,12-mth schedule) at 1 mth PD2 is <1.5

Critère d'inclusion

• Vaccination against HZ and its related complications in adults older than 50 years

Liens

• ictrp
• euctr