Shingrix (Herpes Zoster vaccine Recombinant, adjuvanted)

Product menu

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

SHINGRIX has a clinically acceptable safety and tolerability profile.1,2

Note: depending on the dimensions of your device scrolling or zooming may be required to view all information

Please note safety information on this page relates to ZOE-50 and ZOE-70 clinical trial data

PREV
NEXT

The majority of solicited local adverse reactions were mild to moderate in two large, phase 3 clinical studies of immunocompetent individuals aged 50 and older (ZOE 50) and 70 years and older (ZOE 70).3,4

ZOE 50/70 local adverse reactions overview table

*Grade 3 injection site reactions = Grade 3 pain defined as pain that prevents normal activity; Grade 3 redness and swelling defined as >100 mm.
n = number of participants recording reaction; N=total number

Adverse reactions were evaluated using data from a reactogenicity subgroup of participants in ZOE-50 and ZOE-70.3,4

  • Solicited local adverse reactions were pain, redness, and swelling at the injection site.3,4
  • In both studies, the majority of solicited local and systemic adverse reactions were most commonly mild to moderate in severity and transient in duration (ZOE-50: median duration of local and systemic reactions ranged from 1 to 3 days; ZOE-70: median durations of 2 to 3 days for local reactions and 1 to 2 days for systemic reactions).3,4
  • Reactions reported as severe lasted 1 to 2 days.3,4

For further safety information on SHINGRIX including adverse reactions reported during post-marketing surveillance, please consult the Summary of Product Characteristics.

GRADE 3 DEFINITIONS3,4
Grade 3 pain Prevents normal activities
Grade 3 redness and swelling >100 mm in size
Grade 3 myalgia, fatigue, headache, shivering, and GI symptoms Preventing normal activity
Grade 3 fever >39.0oC

The majority of solicited systemic adverse reactions were mild to moderate in two large, phase 3 clinical studies of immunocompetent individuals aged 50 and older (ZOE 50) and 70 years and older (ZOE 70).3,4

ZOE 50/70 systemic adverse reactions overview table

*Grade 3 myalgia, fatigue, headache, shivering, and GI symptoms defined as preventing normal activity. Grade 3 fever defined as temperature >39.0°C. Oral was the preferred recording method for temperature.
‡GI=Gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.
n=number of participants recording reaction; N=total number.

Adverse reactions were evaluated using data from a reactogenicity subgroup of participants in ZOE-50 and ZOE-70.3,4

  • The most common systemic adverse reaction was myalgia followed by fatigue, headache, shivering, fever and GI symptoms in descending order.3,4
  • In both studies, the majority of solicited local and systemic adverse reactions were most commonly mild to moderate in severity and transient in duration (ZOE-50: median duration of local and systemic reactions ranged from 1 to 3 days; ZOE-70: median durations of 2 to 3 days for local reactions and 1 to 2 days for systemic reactions).3,4
  • Reactions reported as severe lasted 1 to 2 days3,4

For further safety information on SHINGRIX including adverse reactions reported during post-marketing surveillance, please consult the Summary of Product Characteristics.1,2

GRADE 3 DEFINITIONS3,4
Grade 3 pain  Prevents normal activities
Grade 3 redness and swelling  >100 mm in size 
Grade 3 myalgia, fatigue, headache, shivering, and GI symptoms   Preventing normal activity 
Grade 3 fever  >39.0oC

Overall rates of serious adverse events were similar in the vaccine and placebo arms in two large, phase 3 clinical studies of immunocompetent individuals aged 50 and older (ZOE 50) and 70 years and older (ZOE 70).3,4

ZOE 50/70 serious adverse reactions overview table

Safety reported throughout the study period in the TVC= total vaccinated cohort, N=total number.
Mean follow up is 3.5 years in ZOE-50 and 4 years in ZOE-70

  • Serious adverse events were recorded for all participants (total vaccinated cohort).3,4
  • For safety, the mean follow-up is 3.5 years in ZOE-50 and 4 years in ZOE-70.3,4

SHINGRIX has also been studied in immunocompromised individuals. Please view this data on the relevant page

View immunocompromised data

Prescribing information (GB)

Download

Prescribing information (NI)

Download

Summary of product characteristics & Patient information leaflet (GB)

open

Summary of product characteristics & Patient information leaflet (NI)

open

References

  1. SHINGRIX. Summary of Product Characteristics (GB)
  2. SHINGRIX. Summary of Product Characteristics (NI)
  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.

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.
© 2024 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.

January 2024 | PM-GB-SGX-WCNT-230009 (v2.0)