title: 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 years old.
  
  
  METHODS
  Subjects were enrolled in a 1:1 ratio to receive 1 dose of ZV or placebo. Subjects were followed for serious adverse experiences (SAEs) for 42 days (primary follow-up period) and 182 days (secondary follow-up period) postvaccination. Relative-risks (ZV/placebo) for SAEs during both safety periods were calculated.
  
  
  METHODS
  17-Sep‑2007 to 09-Jan-2009.
  
  
  RESULTS
  Overall, 5,983 subjects received ZV and 5,997 received placebo. Within the primary 42-day follow-up period, 84 ZV subjects and 67 placebo subjects reported SAEs. The estimated risk of SAEs within 42 days was 1.41% for ZV versus 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-day follow-up period, 340 ZV subjects and 300 placebo subjects reported SAEs. The estimated risk of SAEs within 182 days was 5.68% for ZV versus 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 SAEs 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 SAEs 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-day follow-up period. No deaths were deemed vaccine-related.
  
  
  CONCLUSIONS
  ZV and placebo groups had similar safety profiles in terms of SAEs during the primary (Day 1 to 42) and secondary (Day 1 to 182) follow-up periods.
authors: PharmQuest, Greensboro, NC USA. amurray@pharmquest.biz
authors: Alexander V
authors: AV
authors: Murray
authors: Keith S
authors: KS
authors: Reisinger
authors: Boris
authors: B
authors: Kerzner
authors: Jon E
authors: JE
authors: Stek
authors: Timothy A
authors: TA
authors: Sausser
authors: Jin
authors: J
authors: Xu
authors: William W
authors: WW
authors: Wang
authors: Ivan S F
authors: IS
authors: Chan
authors: Paula W
authors: PW
authors: Annunziato
authors: Janie
authors: J
authors: Parrino
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006562:Herpes Zoster / Q000276:immunology / Q000517:prevention & control*; D053061:Herpes Zoster Vaccine / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014611:Vaccination
chemical_list: D053061:Herpes Zoster Vaccine