Safety Profile
Studied in 2 Phase 3 Clinical Trials1
Solicited Local Reactions and General Adverse Events Within 7 Days of Vaccination
Aged 50-59 Years All Grades/Grade 3a-e |
Aged 60-69 Years All Grades/Grade 3a-e |
Aged ≥70 Years All Grades/Grade 3a-e |
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Solicited Local Adverse Reactions |
SHINGRIX % n=1315 |
Placebo % n=1312 |
SHINGRIX % n=1311 |
Placebo % n=1305 |
SHINGRIX % n=2258 |
Placebo % n=2263 |
Pain | 88.4 / 10.3 | 14.4 / 0.5 | 82.8 / 6.9 | 11.1 / 0.5 | 69.2 / 4.0 | 8.8 / 0.2 |
Redness | 38.7 / 2.8 | 1.2 / 0.0 | 38.4 / 2.6 | 1.6 / 0.0 | 37.7 / 3.1 | 1.2 / 0.0 |
Swelling | 30.5 / 1.1 | 0.8 / 0.0 | 26.5 / 0.5 | 1.0 / 0.0 | 23.0 / 1.3 | 1.1 / 0.0 |
Solicited General Adverse Events |
n=1315 | n=1312 | n=1309 | n=1305 | n=2252 | n=2264 |
Myalgia | 56.9 / 8.9 | 15.2 / 0.9 | 49.0 / 5.3 | 11.2 / 0.8 | 35.1 / 2.8 | 9.9 / 0.4 |
Fatigue | 57.0 / 8.5 | 19.8 / 1.8 | 45.7 / 5.0 | 16.8 / 0.8 | 36.6 / 3.5 | 14.4 / 0.8 |
Headache | 50.6 / 6.0 | 21.6 / 1.7 | 39.6 / 3.7 | 15.6 / 0.2 | 29.0 / 1.5 | 11.8 / 0.4 |
Shivering | 35.8 / 6.8 | 7.4 / 0.2 | 30.3 / 4.5 | 5.7 / 0.3 | 19.5 / 2.2 | 4.9 / 0.3 |
Feverd | 27.8 / 0.4 | 3.0 / 0.2 | 23.9 / 0.5 | 3.4 / 0.2 | 14.3 / 0.1 | 2.7 / 0.1 |
GIe | 24.3 / 2.1 | 10.7 / 0.7 | 16.7 / 0.9 | 8.7 / 0.6 | 13.5 / 1.2 | 7.6 / 0.4 |
Aged 50-59 Years All Grades/Grade 3a-e |
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Solicited Local Adverse Reactions |
SHINGRIX % n=1315 |
Placebo % n=1312 |
Pain | 88.4 / 10.3 | 14.4 / 0.5 |
Redness | 38.7 / 2.8 | 1.2 / 0.0 |
Swelling | 30.5 / 1.1 | 0.8 / 0.0 |
Solicited General Adverse Events |
n=1315 | n=1312 |
Myalgia | 56.9 / 8.9 | 15.2 / 0.9 |
Fatigue | 57.0 / 8.5 | 19.8 / 1.8 |
Headache | 50.6 / 6.0 | 21.6 / 1.7 |
Shivering | 35.8 / 6.8 | 7.4 / 0.2 |
Feverd | 27.8 / 0.4 | 3.0 / 0.2 |
GIe | 24.3 / 2.1 | 10.7 / 0.7 |
Aged 60-69 Years All Grades/Grade 3a-e |
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Solicited Local Adverse Reactions |
SHINGRIX % n=1311 |
Placebo % n=1305 |
Pain | 82.8 / 6.9 | 11.1 / 0.5 |
Redness | 38.4 / 2.6 | 1.6 / 0.0 |
Swelling | 26.5 / 0.5 | 1.0 / 0.0 |
Solicited General Adverse Events |
n=1309 | n=1305 |
Myalgia | 49.0 / 5.3 | 11.2 / 0.8 |
Fatigue | 45.7 / 5.0 | 16.8 / 0.8 |
Headache | 39.6 / 3.7 | 15.6 / 0.2 |
Shivering | 30.3 / 4.5 | 5.7 / 0.3 |
Feverd | 23.9 / 0.5 | 3.4 / 0.2 |
GIe | 16.7 / 0.9 | 8.7 / 0.6 |
Aged ≥70 Years All Grades/Grade 3a-e |
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Solicited Local Adverse Reactions |
SHINGRIX % n=2258 |
Placebo % n=2263 |
Pain | 69.2 / 4.0 | 8.8 / 0.2 |
Redness | 37.7 / 3.1 | 1.2 / 0.0 |
Swelling | 23.0 / 1.3 | 1.1 / 0.0 |
Solicited General Adverse Events |
n=2252 | n=2264 |
Myalgia | 35.1 / 2.8 | 9.9 / 0.4 |
Fatigue | 36.6 / 3.5 | 14.4 / 0.8 |
Headache | 29.0 / 1.5 | 11.8 / 0.4 |
Shivering | 19.5 / 2.2 | 4.9 / 0.3 |
Feverd | 14.3 / 0.1 | 2.7 / 0.1 |
GIe | 13.5 / 1.2 | 7.6 / 0.4 |
The majority of solicited adverse reactions were mild to moderate (Grade 1 or 2).
Median duration of the above solicited adverse reactions was 2 to 3 days.1-3
- aGrade 3 pain defined as significant pain at rest; prevents normal everyday activities.1
- bGrade 3 redness and swelling defined as >100 mm in size.3
- cGrade 3 myalgia, fatigue, headache, shivering, GI defined as preventing normal activity.1
- dFever defined as ≥37.5°C/99.5°F for oral, axillary, or tympanic route, or ≥38°C/100.4°F for rectal route; Grade 3 fever defined as >39.0°C/102.2°F.1
- eGI=Gastrointestinal symptoms, including nausea, vomiting, diarrhea, and/or abdominal pain.1
Rates observed during 1-year follow-up period1
SAE=serious adverse event.
pIMD=potential immune-mediated disease.
Study Analysis: The safety of SHINGRIX was evaluated by pooling data from 2 placebo-controlled clinical trials involving 29,305 subjects aged 50 years and older who received at least 1 dose of SHINGRIX (N=14,645) or placebo (saline solution) (N=14,660) administered according to a 0- and 2-month schedule. In Studies 1 and 2, data on solicited local and general adverse events were collected using standardized diary cards for 7 days following each vaccine dose or placebo (ie, day of vaccination and the next 6 days) in a subset of subjects (n=4886 receiving SHINGRIX, n=4881 receiving placebo with at least 1 documented dose).1
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CDC=Centers for Disease Control and Prevention.
- *Data from the phase 3 ZOE-50 (≥50 years of age) trial and pooled data in individuals ≥70 years of age from the phase 3 ZOE-50 and ZOE-70 trials from subjects who received 2 doses of SHINGRIX (N=7344 and 8250, respectively) or placebo (N=7415 and 8346, respectively) and did not develop a confirmed case of herpes zoster within 1 month after the second dose. See study designs on Efficacy page for more details.1
References: 1. Prescribing Information for SHINGRIX. 2. Cunningham AL, Lal H, Kovac M, et al, for the ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019-1032. 3. Lal H, Cunningham AL, Godeaux O, et al, for the ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-2096. 4. 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;13(8):1789-1797. 5. Chlibek R, Smetana J, Pauksens K, 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;32(15):1745-1753.
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