You are now leaving GSK’s website

You are now leaving a GSK Website. By clicking this link, you will be taken to a website that is not owned or controlled by GSK, and GSK is not responsible for the content provided on that site

Continue

Go back

SHINGRIX clinical trials

The efficacy of SHINGRIX was studied in 2 phase III trials with 29,305 patients 1

In two placebo-controlled, observer-blind, Phase III trials conducted in 18 countries subjects ≥50 years old (ZOE-50) and subjects ≥70 years old (ZOE-70), were randomized to receive two doses (0 and 2 months) of either SHINGRIX or placebo1

Visual shows the study design of the ZOE-50 and ZOE-70 clinical trials. For any additional questions please call GSK customer service at 1-800-387-7374.

Modified Total Vaccinated Cohort (mTVC): The primary efficacy analysis included all subjects who did not develop a confirmed case of shingles within 1 month after the second dose. 1-3

Primary endpoints: 1-3

  • ZOE-50: to evaluate the efficacy of SHINGRIX vs. placebo in reducing the risk of shingles in subjects ≥50 years old
  • ZOE-70: to evaluate the efficacy of SHINGRIX vs. placebo in reducing the risk of shingles in subjects ≥70 years old
  • The pooled analysis of ZOE-50 and ZOE-70: to evaluate the efficacy of the vaccine vs. placebo, in reducing the risk of shingles and the incidence of PHN in the overall population of subjects ≥70 years old from both studies

Key secondary endpoint: 13

  • To evaluate the safety and reactogenicity of the vaccine

HZ=herpes zoster

References:

  1. SHINGRIX Product Monograph. GlaxoSmithKline Inc., October 13, 2017.
  2. Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang S-J, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May;372(22):2087-96.
  3. Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang S-J, Diez-Domingo J, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016 Sep;375(11):1019-32.