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SHINGRIX (herpes zoster vaccine, recombinant, adjuvanted) demonstrated >90% efficacy against shingles in all age groups 50 years of age and older, based on pooled data from two large, phase 3 randomised controlled trials.1-3

SHINGRIX efficacy against shingles in patients 50 years of age and older based on pooled data from two large, phase 3 randomised controlled trials.2,3

patient efficacy across multiple ages patient efficacy across multiple ages

Disclaimer: The graph has been independently created by GSK from the original data. The same results were first published in Lal et al. 2015 and Cunningham et al. 2016.

ZOE-50 study: Median follow-up period of 3.1 years.

Pooled analysis from ZOE-50 & ZOE-70 studies: Median follow-up period of 4 years.

Data in subjects 70 years of age and older are sourced from the pre-specified pooled analyses of ZOE-50 and ZOE-70 (mTVC) as these analyses provide robust estimates for vaccine efficacy in this age group.

Patient population: Modified vaccinated cohort (mTVC) - excluded participants who did not receive the second dose or who had a confirmed case of HZ within 1 month after the second dose.2,3

p values for all comparisons were <0.001.2,3

Study designs

Study 1 design: Data from ZOE-50—a placebo-controlled, observer-blind, phase 3 trial conducted in 18 countries in which subjects ≥50 years old were randomised to receive 2 doses (0 and 2 months) of either SHINGRIX (N=7698) or placebo (N=7713). A total of 7344 and 7415 subjects who received SHINGRIX and placebo, respectively, were included in the modified Total Vaccinated Cohort (mTVC) analysis.1,2

Study 2 design: Data from ZOE-70—a placebo-controlled, observer-blind, phase 3 trial conducted in 18 countries in which subjects ≥70 years old were randomised to receive 2 doses (0 and 2 months) of either SHINGRIX (N=6950) or placebo (N=6950). A total of 6541 and 6622 subjects who received SHINGRIX and placebo, respectively, were included in the mTVC analysis.1,3

The modified vaccinated cohort (mTVC) - excluded participants who did not receive the second dose of recombinant zoster vaccine or placebo or who had a confirmed case of HZ within 1 month after the second dose.2,3

Pooled analysis: Data from ZOE-50 and ZOE-70 were combined in a prespecified pooled analysis. A total of 8250 and 8346 subjects ≥70 years of age who received SHINGRIX and placebo, respectively, were included.1-3 Exclusion criteria for these studies included subjects with a history of herpes zoster, subjects who had previously been vaccinated against varicella or herpes zoster and those with an immunosuppressive condition.2,3

SHINGRIX has provided sustained efficacy against HZ in adults 50 years of age or older for at least 7 years and continues to be monitored.1-4

Sustained vaccine efficacy against herpes zoster post vaccination (mean follow-up 3.7 years) in adults 70 years of age and older.3

years post vaccination efficacy graph years post vaccination efficacy graph

The graph has been independently created by GSK from the original data. The same results were first published in Cunningham et al. 2016.

Year 1 = from 30 days to 395 days after second vaccination, Year 2 = from >396 to 760 days after second vaccination, Year 3 = from >761 days to 1125 days after second vaccination, Year 4 = from >1125 days after second vaccination to last contact date. Mean follow-up of 3.7 years.

Study design: Data shown in the graph represents subjects 70 years of age and older from pooled analysis of two large, phase 3 randomised controlled trials: ZOE-50 and ZOE-70 study, who received a second dose of the vaccine and did not develop a confirmed case of HZ within 1 month after the second dose. Mean follow-up is 3.7 years. The duration of protection beyond 4 years is currently under investigation.3

HZ = herpes zoster, mTVC = modified vaccinated cohort.

Learn more about SHINGRIX

References

  1. Shingrix, Summary of Product Characteristics (SPC), available on https://www.medicines.ie/medicines/shingrix-powder-and-suspension-for-suspension-for-injection-herpes-zoster-vaccine-recombinant-adjuvanted--35192/spc. Last Accessed: April 2022
  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.
  4. Boutry et al. The Adjuvanted Recombinant Zoster Vaccine Confers Long-term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase III Clinical Trials (ZOE-50 and ZOE-70). Clin Infect Dis. 2021 Jul 20;ciab629. doi: 10.1093/cid/ciab629.
  5. Harpaz R, et al. MMWR Recomm Rep. 2008 June;57(RR-5):1-30. 2. Zerboni L, et al. Nat Rev Microbiol. 2014 Mar;12 (3):197-210.
  6. Bollaerts K et al. A systematic review of varicella seroprevaience in European countries before universal childhood immunization: deriving incidence from seroprevaience data. Epidemiol. Infect. (2017), 145, 2666-2677.
  7. Gauthier et al. Epidemiology and costs of herpes zoster and postherpetic neuralgia in the United Kingdom. Epidemiol infecti. 2009 137 38-472.
  8. Kimberlin DW, Whitley RJ. Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007 Mar;356 (13):1338-43.
  9. Chlibek R, Smetana J, Pauksens K, Rombo L, Van den Hoek JA, Richardus JH, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014 Mar;32 (15):1745-53.
  10. Leroux-Roels I, Leroux-Roels G, Clement F, Vandepapelière P, Vassilev V, Ledent E, Heineman TC. A phase 1 /2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults. J Infect Dis. 2012 Oct;206 (8):1280-90.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie . Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

SHINGRIX is owned by or licensed to the GSK group of companies.
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PM-IE-SGX-WCNT-210003 Date of Preparation: April 2022