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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.1-4

SHINGRIX efficacy against shingles in patients 50 years of age and older based on pooled data from two large, phase 3 randomised controlled trials.3,4

Infographic depicting SHINGRIX efficacy against Shingles within different age cohorts. This data is from the ZOE-50 study and pooled analysis from ZOE-50 and ZOE-70 studies. SHINGRIX demonstrated >90% efficacy against shingles in all age groups older than 50 years of age.3,4 Infographic depicting SHINGRIX efficacy against Shingles within different age cohorts. This data is from the ZOE-50 study and pooled analysis from ZOE-50 and ZOE-70 studies. SHINGRIX demonstrated >90% efficacy against shingles in all age groups older than 50 years of age.3,4

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.3,4

p values for all comparisons were <0.001.3,4

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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.1-3

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.1,2,4

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.3,4

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.1,2,4 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.3,4

SHINGRIX has demonstrated sustained vaccine efficacy against shingles post vaccination and continues to be monitored (mean follow-up 3.7 years).1-4

Sustained vaccine efficacy against herpes zoster post vaccination (mean follow-up 3.7 years) in adults 70 years of age and older.4

Bar graph showing SHINGRIX sustained vaccine efficacy by year against herpes zoster post vaccination (mean follow up 3.7 years) in adults 70 years of age and older3. Bar graph showing SHINGRIX sustained vaccine efficacy by year against herpes zoster post vaccination (mean follow up 3.7 years) in adults 70 years of age and older3.

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.4

HZ = herpes zoser, mTVC = modified vaccinated cohort.

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Learn more about SHINGRIX

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Who can benefit from SHINGRIX?

There is a 1 in 4 lifetime risk of developing shingles.5 Age-related decline in immunity puts patients 50 years of age and older at an increased risk of developing shingles.6,7

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Addressing age-related decline in immunity.

SHINGRIX – specifically formulated to help address age-related decline in varicella zoster virus specific immunity in adults 50 years of age and older.1,2,8,9

UNDERSTAND THE SCIENTIFIC RATIONALE

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Learn more about the safety profile of SHINGRIX.

The majority of local and systemic adverse reactions were mild to moderate and transient, based on two large, phase 3 randomised controlled trials. Reactions reported as severe lasted 1 to 2 days.1-4

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References

  1. Shingrix, GB Summary of Product Characteristics (SPC)
  2. Shingrix, NI Summary of Product Characteristics (SPC)
  3. 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.
  4. 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.
  5. DH Green Book ch 28a - Shingles. February 2016. Accessed July 2021.
  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. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441

PM-GB-SGX-WCNT-210009
Date of preparation: July 2021
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