Shingrix (Herpes Zoster vaccine Recombinant, adjuvanted)

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SHINGRIX demonstrated >90% efficacy against Herpes zoster in immunocompetent patients ≥50 years of age.1,2

Note: The efficacy data outlined on this webpage relates to immunocompetent individuals only. For more information on SHINGRIX data in immunocompromised individuals please explore the "Immunocompromised patients" section

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  • SHINGRIX phase 3 randomised controlled trials data in immunocompetent populations

    SHINGRIX efficacy against shingles in patients 50 years of age and older based on pooled data from two large, phase 3 randomised controlled trials.1,2

    ZOE 50/70 clinical trial efficacy overview

    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.1

    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.2

    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.1,2
    p values for all comparisons were presented <0.001.1,2

    n= number of herpes zoster cases, N = number of participants

    Study designs

    Study 1 design: ZOE50 was a randomised, observer-blind, placebo-controlled. multicenter, 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

    Study 2 design: ZOE70 was a randomised, observer-blind, placebo-controlled. multicenter, 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.2

    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.2

  • SHINGRIX long term efficacy data in immunocompetent populations

    Shingrix demonstrated protection against HZ for up to 11 years post-vaccination in an open-label, long-term follow-up study of adults vaccinated aged ≥50 years in the ZOE-50/70 studies.3

    NA NA

    No new concerns regarding SHINGRIX long-term safety were identified during the 6-11-year follow-up period in Z0E-049 study.3

    ZOE-049 started at a median of 5.6 years post-vaccination in ZOE-50/70 studies and completed after a median follow-up of 11.4 years.3

    *Placebo/HC: Data from participants in SHINGRIX vs placebo arms of ZOE-50/70 studies were compared for Years 1 through to 4 to determine vaccine efficacy.10 For Years 6 onwards, data from participants in SHINGRIX arm were compared to historical control estimates.9,10 The placebo arms in ZOE-50/70 studies were used to form the historical control estimates.4

    †ZOE-502 and ZOE-703 are randomised, placebo-controlled, multicenter, phase III trials of SHINGRIX vs placebo in adults aged ≥50 years and ≥70 years, respectively.

    ††ZOE-049 study design: Phase IIIb, open-label, multicenter, long-term follow-up study of adults who were vaccinated aged ≥ 50 years in the ZOE-50 or ZOE-70 pivotal phase III trials. It evaluated the long-term efficacy, safety and immunogenicity of SHINGRIX against herpes zoster (HZ), and represents an additional 6 years of follow-up over the ZOE-50 and-70 studies.3

    As more than half of the placebo recipients from ZOE-50/70 were vaccinated with SHINGRIX in a subsequent study, historical control estimates of incidence rates from ZOE-50/70 placebo arms were used as the comparator to assess vaccine efficacy in ZOE-049.3

    The primary objective of the ZOE-049 study was Vaccine Efficacy (VE) against first or only herpes zoster episode (HZ) over the total duration of the 6-11 year follow-up period in the mTVC (modified total vaccinated cohort). The mTVC consisted of participants who received both SHINGRIX doses and did not develop HZ during ZOE-50/70. The placebo arms in ZOE-50/70 studies were used to form the historical control estimates for Years 6 onwards, with the number of participants (N) and follow-up time assumed to be the same as in the vaccinated group. VE were adjusted for region.3

    The secondary objectives included VE against first or only HZ episode from 1 month post-dose 2 in ZOE-50/70 through to the end of the ZOE-049 study - overall, by year post-vaccination, and stratified by age group.3 Participant follow-up varied from up to approx. 4 years in ZOE-50/701,2 (for participants not enrolled in ZOE-049) to up to approx. 11 years for subjects enrolled in ZOE-049.5 The placebo arms in ZOE-50/70 studies were used as the comparator for analyses in Years 1 through to 4, and to form the historical control estimates which were for analyses in Years 6 onwards. VE were adjusted for region.3

    Safety was also assessed.3

    *Placebo/HC: Data from participants in SHINGRIX vs placebo arms of ZOE-50/70 studies were compared for Years 1 through to 4 to determine vaccine efficacy. For Years 6 onwards, data from participants in SHINGRIX arm was compared to historical control estimates. The placebo arms in ZOE-50/70 studies were used to form the historical control estimates.    

    **No data available for year 5 as this period corresponds to the gap between ZOE-50/70 studies and start of ZOE-049

    The graph has been independently created by GSK from the original data.
    CI: Confidence Interval; HC: historical control; HZ: Herpes zoster; mTVC: modified total vaccinated cohort; N: number of individuals included in each arm; n: number of individuals having at least one confirmed herpes zoster episode; VE: vaccine efficacy

    ZOSTER-049 study design

    Design
    • Open-label, long-term follow-up study of participants from ZOE-50 and ZOE-703
    Population
    • Adults vaccinated aged ≥50 years in ZOE-50 or ZOE-70 studies3
    Primary objective
    • Vaccine efficacy against HZ over the total duration of the 6-11 year follow-up period in ZOE-0493
    Key secondary objectives
    • Vaccine efficacy against HZ from 1-month post-dose 2 in ZOE- 50/ZOE-70 through to the end of the ZOE-049 study - overall, by year of post-vaccination follow-up, and stratified by age group.3,4
    • Vaccine efficacy against HZ over the total duration of the 6-11 year follow up period stratified by age group.4
    • Persistence of vaccine-induced:
      • Humoral immunogenicity (anti-gE antibody concentrations by ELISA)
      • Cell-mediated immune response (frequency of gE-specific CD4[2+] T cells by intracellular cytokine staining)
    • Safety3
     
     

For more information on the SHINGRIX safety profile in immunocompetent populations please view our safety page

VIEW SHINGRIX SAFETY DATA

For information on SHINGRIX data in immunocompromised individuals, please explore the 'immunocompromised patients' section

Prescribing information (UK)

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Summary of product characteristics & Patient information leaflet (UK)

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References

  1. Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang S-J,&nbsp;et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May;372(22):2087-96.
  2. Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang S-J, Diez-Domingo J,&nbsp;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.
  3. Strezova A, Díez Domingo J, Cunningham AL, et al. eClinical Medicine 2025; 83: 103241.
  4. Strezova A, Díez Domingo J, Cunningham AL, et al. eClinical Medicine 2025; 83: 103241. (Suppl Appendix).
  5. Strezova A, Díez Domingo J, Al Shawafi K, et al. Open Forum Infect Dis 2022; 9(10): ofac485.

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 GSK on 0800 221 441 or UKSafety@gsk.com.

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June 2026 | PM-GB-SGX-WCNT-260024 (V1.0)