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Recommend SHINGRIX (herpes zoster vaccine, recombinant, adjuvanted) with confidence to patients aged 50 years of age and older.1

SHINGRIX has a clinically acceptable safety and tolerability profile.1-3

The majority of solicited local adverse reactions were mild to moderate based on data from two large, phase 3 clinical studies.2,3

 

ZOE 502

ZOE 703

Injection-site reaction

SHINGRIX
%
N=4382

Placebo
%
N=4377

SHINGRIX
%
N=505

Placebo
%
N=505

Pain

79.1
(n=3464)

11.2
(n=490)

68.7
(n=347)

8.5
(n=43)

Redness

38.0
(n=1664)

1.3
(n=59)

39.2
(n=198)

1.0
(n=5)

Swelling

26.3
(n=1153)

1.1
(n=46)

22.6
(n=114)

0.4
(n=2)

Grade 3 injection-site reactions*

9.5
(n=417)

0.4
(n=16)

8.5
(n=43)

0.2
(n=1)

*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-70.2,3

  • Solicited local adverse reactions were pain, redness, and swelling at the injection site.
  • 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).2,3
  • Reactions reported as severe lasted 1 to 2 days.2,3

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

GRADE 3 DEFINITIONS2,3

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 based on data from two large, phase 3 randomised control trials.2,3

 

ZOE 502

ZOE 703

Systemic reaction

SHINGRIX
%
N=4375

Placebo
%
N=4378

SHINGRIX
%
N=504

Placebo
%
N=505

Myalgia

46.3
(n=2025)

12.1
(n=530)

31.2
(n=157)

8.1
(n=41)

Fatigue

45.9
(n=2008)

16.6
(n=728)

32.9
(n=166)

15.2
(n=77)

Headache

39.2
(n=1716)

16.0
(n=700)

24.6
(n=124)

10.9
(n=55)

Shivering

28.2
(n=1232)

5.9
(n=259)

14.9
(n=75)

4.4
(n=22)

Fever

21.5
(n=939)

3.0
(n=132)

12.3
(n=62)

2.6
(n=13)

Gl

18.0
(n=788)

8.8
(n=387)

10.9
(n=55)

7.9
(n=40)

Grade 3 systemic reactions

11.4
(n=498)

2.4
(n=106)

6.0
(n=30)

2.0
(n=10)

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-70.2,3

  • The most common systemic adverse reaction was myalgia followed by fatigue, headache, shivering, fever and GI symptoms in descending order.2,3
  • 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).2,3
  • Reactions reported as severe lasted 1 to 2 days2,3

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

GRADE 3 DEFINITIONS2,3

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

No increases in serious adverse events vs placebo were observed in the ZOE-50 and ZOE-70 studies2,3

 

ZOE 50 (TVC)2

ZOE 70 (TVC)3

 

SHINGRIX
%
N=7698

Placebo
%
N=7713

SHINGRIX
%
N=6950

Placebo
%
N=6950

Serious adverse events

9
(n=689)

8.9
(n=686)

16.6
(n=1153)

17.5
(n=1214)

Potential immune-mediated diseases

1
(n=78)

1.3
(n=97)

1.3
(n=92)

1.4
(n=97)

Death

2.2
(n=167)

2.3
(n=174)

6.1
(n=426)

6.6
(n=459)

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).2,3
  • The safety profile was acceptable, there were no increases in serious adverse events between the vaccinated and placebo group.2,3
  • For safety, the mean follow-up is 3.5 years in ZOE-50 and 4 years in ZOE-70.2,3

Recommend SHINGRIX with confidence to patients 50 years of age and older.1

No increase in serious adverse events vs placebo were observed in both ZOE-50
(mean follow-up 3.5 years)2 and ZOE-70 (mean follow-up 4.0 years).

Learn more about SHINGRIX

References

  1. Shingrix, Summary of Product Characteristics (SPC), available on https://www.medicines.ie/medicines/shingrix-powder-and-suspension-for-suspension-for-injection-herpes-zoster-vaccine-recombinant-adjuvanted--35192/spc. Last Accessed: March 2022
  2. 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.
  3. 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.
  4. 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.
  5. 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 directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie . Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

SHINGRIX is owned by or licensed to the GSK group of companies.
© 2022 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.

Date of preparation: March 2022 PM-IE-SGX-WCNT-210005