Safety and tolerability of zoster vaccine in adults ≥60 years old

Abstract

Objective: To evaluate the general safety of zoster vaccine (ZV) in adults ≥60 y old. Results: Overall, 5,983 subjects received ZV and 5,997 received placebo. Within the primary 42-d follow-up period, 84 ZV subjects and 67 placebo subjects reported SAE s. The estimated risk of SAE s within 42 d was 1.41% for ZV vs. 1.12% for placebo, with a relative-risk of 1.26 (95% CI: 0.91, 1.73); indicating no statistically significant difference between groups, meeting the pre-specified success criterion. During the 182-d follow-up period, 340 ZV subjects and 300 placebo subjects reported SAE s. The estimated risk of SAE s within 182 d was 5.68% for ZV vs. 5.01% for placebo, with a relative-risk of 1.13 (95% CI: 0.98, 1.32), indicating no statistically significant difference between groups. Two subjects in the ZV group reported SAE s deemed by the investigator to be vaccine-related (uveitis and sciatica; onset Day 5 and 4, respectively). One subject in the placebo group reported a SAE deemed by the investigator to be vaccine-related (lumbar radiculopathy; onset Day 51). There were 24 fatal SAE s in the ZV group and 17 in the placebo group (relative risk = 1.41; CI: 0.77, 2.60); 6 and 5, respectively, with SAE onset during the primary 42-d follow-up period. No deaths were deemed vaccine-related. Patients/Methods: Subjects were enrolled in a 1:1 ratio to receive 1 dose of ZV or placebo. Subjects were followed for serious adverse experiences (SAE s) for 42 d (primary follow-up period) and 182 d (secondary follow-up period) postvaccination. Relative-risks (ZV/placebo) for SAE s during both safety periods were calculated. Study period: 17-Sep-2007 to 09-Jan-2009. Conclusions: ZV and placebo groups had similar safety profiles in terms of SAE s during the primary (Day 1 to 42) and secondary (Day 1 to 182) follow-up periods. © 2011 Landes Bioscience.