Shingrix (Herpes Zoster vaccine Recombinant, adjuvanted)

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60 year old woman in pain with shingles rash on her face

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

    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 has demonstrated protection against shingles that lasts for up to 10 years post vaccination (range 5.6 to 9.6 years) in an interim analysis of a long term, open-label follow-up study (Zoster- 049) of two phase 3 studies (ZOE-50 & ZOE-70).3

    Long term efficacy data overview

    The graph has been independently created by GSK from the original data

    HC, Historical Controls; CI, Confidence Interval; HZ, Herpes Zoster; mTVC, modified total vaccinated cohort; N, number of individuals included in each group; n, number of individuals having at least one confirmed herpes zoster episode; VE, vaccine efficacy; DLP, data lock point, DLP set when the last participant had reached 4-year of follow up.3

    *Primary objective (descriptive analysis): VE against HZ over the ZOSTER-049 study. Follow up during interim analysis: ≥ 4 years in ZOSTER-049 until DLP - Mean 5.6 (±0.3) to 9.6 (±0.3) years post vaccination in ZOE-50/70 cases (n/N) in Shingrix group (52/7,277). Secondary objective (descriptive analysis): VE against HZ from 1-month post-dose 2 in the ZOE50/70 studies up to 9.6 (±0.3) years post vaccination. HZ cases (n/N) in Shingrix group (84/13,881) and control group (746/13,881)3

    In the ZOE-50/70 studies the comparator was placebo. In ZOE-49, historical control estimates from ZOE50/70 placebo groups were used.3,4

    **No data are available for year 5 because that period corresponds to the gap between ZOE-50/70 and the Zoster-049 follow up study3,4

    ^Of the 14,648 ZOE- 50/70 participants who recieved at least 1 Shingrix dose 7,413 (50.6%) were enrolled in ZOSTER-049. Of these, 7,277 had previously recieved both Shingrix doses and were included in the mTVC for the efficacy assessments. In the absence of an unvaccinated placebo group for the LTFU study, the efficacy analyses in ZOSTER-049 used HC estimated from the ZOE-50/70 placebo groups during the trials. At this DLP, data was complete through year 9. Results for year 10 are also included although still incomplete, precision of estimates for this time point will increase at the final analysis.3,4

    ZOSTER-049 study design

    Long term analysis study design Long term analysis study design

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 (GB)

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Prescribing information (NI)

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Summary of product characteristics & Patient information leaflet (GB)

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Summary of product characteristics & Patient information leaflet (NI)

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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, et al. Long term protection against Herpes Zoster by the adjuvanted Recombinant Zoster Vaccine: interim efficacy, immunogenicity, and safety results up to 10 years after initial vaccination. Open Forum Infectious Diseases. 2022 Oct; 9(10): ofac485. Published online 2022 Oct 23. doi: 10.1093/ofid/ofac485
  4. Boutry, Celine et al. The Adjuvanted Recombinant Zoster Vaccine Confers Long-term Protection Against Herpes Zoster: Interim Results of an Extension Study on the Pivotal Phase III Clinical Trials (ZOE-50 and ZOE-70). Clinical Infectious diseases: an official publication of the Infectious Diseases Society of America, ciab629. 20 Jul. 2021, doi:10.1093/cid/ciab629

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/.
Adverse events should also be reported to GlaxoSmithKline UK on 0800 221 441.

SHINGRIX is owned by or licensed to the GSK group of companies.
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Trade marks are owned by or licensed to the GSK group of companies.

January 2024 | PM-GB-SGX-WCNT-230010 (V2.0)