SHINGRIX efficacy data

SHINGRIX demonstrated >90% efficacy against shingles in all age groups studied vs. placebo.1-3

Table with efficacy data from the ZOE-50 and ZOE-70 clinical trials Table with efficacy data from the ZOE-50
Table with efficacy data from the ZOE-50 and ZOE-70 clinical trials

Adapted from SHINGRIX Product Monograph.

Study Design

In two placebo-controlled, observer-blind, Phase III trials conducted in 18 countries, subjects ≥50 years old (ZOE-50, n=15,405) and subjects ≥70 years old (ZOE-70, n=13,900) were randomized 1:1 to receive two doses (0 and 2 months) of either SHINGRIX or placebo (N=29,305).1

ZOE-50 and ZOE-70 study design infographic ZOE-50 and ZOE-70 study design infographic

Modified Total Vaccinated Cohort (mTVC): The primary efficacy analysis included all subjects randomized in the study who received a second dose of the vaccine and did not develop a confirmed case of shingles within one month after the second dose.

Primary endpoints: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

Secondary endpoint:3

  • To evaluate the safety and reactogenicity of the vaccine

References

  1. SHINGRIX Product Monograph. GlaxoSmithKline Inc., June 3, 2020.
  2. Lal H et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med 2015;372(22):2087-2096.
  3. Cunningham AL et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med 2016;375(11):1019-1032.
  4. Public Health Agency of Canada. An Advisory Committee Statement (ACS), National Advisory Committee on Immunization (NACI) – Updated Recommendations on the Use of Herpes Zoster Vaccines. Ottawa, Ontario: Public Health Agency of Canada; June 2018. Available at: https://www.canada.ca/en/services/health/publications/healthy-living/updated-recommendations-use-herpes-zoster-vaccines.html.
  5. Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008;57(RR-5):1-30.

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PM-CA-SGX-WCNT-210001 | November 2021