SAFETY PROFILE

 

Studied in 2 Phase 3 Clinical Trials1

  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
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

Studied in 2 Phase 3 Clinical Trials

  Aged 50-59 Years
All Grades/Grade 3a-e
Solicited Local Adverse Reactions SHINGRIX%
n=1315
Placebo%
n=1312
Pain 88.4 / 10.3 14.4 / 0.5
Redness 38.7 / 1.2 38.4 / 2.6
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
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 1.1 / 0.0
Solicited General Adverse Events n=1311 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
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 reactions were mild to moderate (grade 1 or 2).
Median duration of reactions was 2 to 3 days.1-3

a Grade 3 pain defined as significant pain at rest; prevents normal everyday activities.1
b Grade 3 redness and swelling defined as >100 mm in size.3
c Grade 3 myalgia, fatigue, headache, shivering, and GI defined as preventing normal activity.1
d Fever 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
e GI=gastrointestinal symptoms, including nausea, vomiting, diarrhea, and/or abdominal pain.

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


Indication

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Important Safety Information

  • SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
  • Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX
  • Solicited local adverse reactions in subjects aged 50 years and older were pain (78.0%), redness (38.1%), and swelling (25.9%)
  • Solicited general adverse reactions in subjects aged 50 years and older were myalgia (44.7%), fatigue (44.5%), headache (37.7%), shivering (26.8%), fever (20.5%), and gastrointestinal symptoms (17.3%)
  • SHINGRIX was not studied in pregnant or lactating women, and it is unknown if it is excreted in human milk. Therefore, it cannot be established whether there is vaccine-associated risk with SHINGRIX in pregnant women or if there are effects on breastfed infants or milk production/excretion
  • Vaccination with SHINGRIX may not result in protection of all vaccine recipients

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.

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1004182R0 April 2018