Results of a Safety Pooled Analysis of an Adjuvanted Herpes Zoster Subunit Vaccine in More than 14,500 Participants Aged 50 Years or Older

ABSTRACT: Abstract

Background

The recombinant herpes zoster (HZ) subunit vaccine (HZ/su) has shown efficacy against HZ in adults ≥50 and ≥70 years of age (YOA), in two pivotal Phase III clinical trials (NCT01165177, NCT01165229). A pooled safety analysis of data from these two efficacy studies was performed, including a comparative analysis on HZ/su vs. placebo groups, to provide a comprehensive understanding of the HZ/su safety profile.

Methods

Two pivotal, randomized, placebo-controlled Phase III studies, assessed the efficacy, reactogenicity and safety of HZ/su, administered intramuscularly according to a 0, 2-month schedule. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each dose, respectively; serious AEs (SAEs) for 1 year after last dos

SUBMITTER: Lopez-Fauqued M 

PROVIDER: S-EPMC5631020 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature