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By preventing shingles, SHINGRIX (herpes zoster vaccine, recombinant, adjuvanted) significantly reduced the risk of post-herpetic neuralgia (PHN).1,2

13,881 patients received SHINGRIX in two phase 3 randomised controlled trials and only 4 cases of PHN were reported. All four cases were in patients 70 years of age or older.1

Table showing SHINGRIX efficacy against post-herpetic neuralgia in adults 50 and older and adults 70 and older. 13,881 patients received SHINGRIX in two phase 3 randomised control trials and only 4 cases of PHN were reported. All four cases were in patients 70 years of age or older.1 Table showing SHINGRIX efficacy against post-herpetic neuralgia in adults 50 and older and adults 70 and older. 13,881 patients received SHINGRIX in two phase 3 randomised control trials and only 4 cases of PHN were reported. All four cases were in patients 70 years of age or older.1

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

Pooled data from two large, phase 3 randomised controlled trials: ZOE-50 (subjects 50 years of age and older) and ZOE-70 (subjects 70 years of age and older). 13,881 patients received SHINGRIX (mTVC).1
4 cases of PHN were reported in the SHINGRIX group. All 4 cases of PHN were in subjects over 70 years of age.1
PHN was defined as HZ-associated pain rated as 3 or higher on a 0-10 scale, occurring or persisting for more than 90 days following the onset of a rash using the Zoster Brief Pain Inventory questionnaire.1,2

In the pooled analysis of ZOE-50 and ZOE-70, SHINGRIX significantly reduce these HZ-related complications versus placebo by 93.7% (95% CI: 59.5; 99.9) and 91.6% (95% CI: 43.3; 99.8) in adults ≥50 years (1 vs.16 cases) and adults ≥70 years (1 vs.12 cases), respectively.3,4 In the pooled analysis of ZOE-50 and ZOE-70, SHINGRIX significantly reduce these HZ-related complications versus placebo by 93.7% (95% CI: 59.5; 99.9) and 91.6% (95% CI: 43.3; 99.8) in adults ≥50 years (1 vs.16 cases) and adults ≥70 years (1 vs.12 cases), respectively.3,4

REDUCTION OF OTHER SHINGLES-RELATED COMPLICATIONS1,2
The evaluated HZ-related complications were: HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease including stroke, and visceral disease. In the pooled analysis of ZOE-50 and ZOE-70, SHINGRIX significantly reduced these HZ-related complications versus placebo by 93.7% (95% CI: 59.5; 99.9) and 91.6% (95% CI: 43.3; 99.8) in adults 50 years of age or older (1 vs.16 cases) and adults 70 years of age or older (1 vs.12 cases), respectively.1,2

HZ=herpes zoster; PHN=post-herpetic neuralgia, CI = confidence interval, mTVC = modified vaccinated cohort.

Learn more about SHINGRIX

References

  1. 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.
  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. Shingrix, Summary of Product Characteristics (SPC) available on https://www.medicines.ie/
  4. 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.
  5. 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.
  6. Gauthier et al. Epidemiology and costs of herpes zoster and postherpetic neuralgia in the United Kingdom. Epidemiol infecti. 2009 137 38-472.
  7.  Kimberlin DW, Whitley RJ. Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007 Mar;356 (13):1338-43.
  8. 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.
  9. 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.
© 2021 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.

Date of Preparation: January 2022 PM-IE-SGX-WCNT-210004