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Meet the patients you can protect1, 5-7
Nearly everyone ≥50 years old needs shingles protection
Recommend SHINGRIX▼ with confidence to patients ≥50 years old
SHINGRIX▼ delivered >90% efficacy against shingles in all age segments ≥50 years old.1
Not actual patients.
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 randomized to receive 2 doses (0 and 2 months) of either SHINGRIX▼ (N=7695) or placebo (N=7710). 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 randomized 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 primary efficacy analysis (mTVC) in Studies 1 and 2 included all subjects who did not develop a confirmed case of HZ within 1 month after the second dose.1
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 The studies excluded subjects who were immunocompromised, had a previous history of HZ, were previously vaccinated against varicella or HZ, and patients whose survival was not expected to be at least 4 years, or with conditions that might interfere with study evaluations.4
*See Study 1 in Study Designs above.
†See Pooled Analysis in Study Designs above.
CI=confidence interval; HZ=herpes zoster.
Shingrix▼ Safety Information1
Contraindications:
Hypersensitivity to the active substances or to any component of the vaccine.
Special warnings and precautions:
As with all injectable vaccines:
- appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine;
- vaccination with Shingrix▼ should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination;
- a protective immune response may not be elicited in all vaccinees.
Do not administer the vaccine intravascularly, intradermally or subcutaneously.
There are no data on the use of Shingrix▼ in pregnant women and the effect on breast-fed infants of administration of Shingrix▼ to their mothers has not been studied.
Adverse reactions:
- Very common (≥1/10): headache, gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), myalgia, injection site reactions (such as pain, redness, swelling), fatigue, chills, fever.
- Common (≥1/100 to <1/10): injection site pruritus, malaise.
Please refer to the full prescribing information for further details.
References
- Approved prescribing information by SFDA for Shingrix▼.
- 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.
- 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.
- US Food and Drug Administration; Vaccines and Related Biological Products Advisory Committee. Briefing document: Shingrix▼ (Zoster Vaccine Recombinant, Adjuvanted). 2017 [accessed May 2020]. Available from: https://www.fda.gov/media/107553/download.
- Kilgore PE, Kruszon-Moran D, Seward JF, Jumaan A, Van Loon FP, Forghani B, et al. Varicella in Americans from NHANES III: implications for control through routine immunization. J Med Virol. 2003;70(suppl 1):S111-18.
- Kimberlin DW, Whitley RJ. Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007 Mar;356(13):1338-43.
- Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008 May;57(RR-5):1-30.
- Levin MJ. Immune senescence and vaccines to prevent herpes zoster in older persons. Curr Opin Immunol. 2012 Aug;24(4):494-500.
- Chlibek R, Smetana J, Pauksens K, Rombo L, Van den Hoek JAR, 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.
- Bharucha T, Ming D, Breuer J. A critical appraisal of ‘Shingrix▼’, a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. Hum Vaccin Immunother. 2017 Aug;13(8):1789-97.
▼This medicine is subjected to additional monitoring. This will allow quick identification of new safety information. You may help by reporting any side effects you may get.
For more information, please refer to the prescribing information or contact GSK: P.O Box 55850, Jeddah, 21544, Kingdom of Saudi Arabia.
Telephone: +966 12 653 6666 or via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via saudi.safety@gsk.com
To report the Quality related product complaint/s associated with the use of GSK product/s, please contact us via ksa.productqualitycomplaint@gsk.com
GSK does not recommend, endorse or accept liability for sites controlled by a third party.
Trademarks are owned by or licensed to the GSK group of companies.
©2025 GSK group of companies or its licensor
GlaxoSmithKline, Jeddah, 21544, Kingdom of Saudi Arabia.
PM-SA-SGX-WCNT-240011 Date of preparation: March 2025
