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 placebo. 1
- 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
- To evaluate the safety and reactogenicity of the vaccine
- SHINGRIX Product Monograph. GlaxoSmithKline Inc., October 13, 2017.
- 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.
- 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.