dose of SHINGRIX (n = 14,645) or saline placebo (n = 14,660) administered according to a 0- and 2-month schedule. At the time of vaccination, the mean age of the population was 69 years; 7,286 (24.9%) subjects were aged 50 to 59 years, 4,488 (15.3%) subjects were aged 60 to 69 years, and 17,531 (59.8%) subjects were aged 70 years and older. Both studies were conducted in North America, Latin America, Europe, Asia, and Australia. In the overall population, the majority of subjects were white (74.3%), followed by Asian (18.3%), black (1.4%), and other racial/ethnic groups (6.0%); 58% were female.
Solicited Adverse Events
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 (i.e., day of vaccination and the next 6 days) in a subset of subjects (n = 4,886 receiving SHINGRIX, n = 4,881 receiving placebo with at least 1 documented dose). Across both studies, the percentages of subjects aged 50 years and older reporting each solicited local adverse reaction and each solicited general adverse event following administration of SHINGRIX (both doses combined) were pain (78.0%), redness (38.1%), and swelling (25.9%); and myalgia (44.7%), fatigue (44.5%), headache (37.7%), shivering (26.8%), fever (20.5%), and gastrointestinal symptoms (17.3%), respectively.
The reported frequencies of specific solicited local adverse reactions and general adverse events (overall per subject), by age group, from the 2 studies are presented in Table 1.
Table 1. Percentage of Subjects with Solicited Local Adverse Reactions and General Adverse Events within 7 Daysa of Vaccination in Adults Aged 50 to 59 Years, 60 to 69 Years, and 70 Years and Olderb (Total Vaccinated Cohort with 7-Day Diary Card)
Aged 50 - 59 Years
Aged 60 - 69 Years
Aged ≥70 Years
SHINGRIX
%
Placeboc
%
SHINGRIX
%
Placeboc
%
SHINGRIX
%
Placeboc
%
Local Adverse Reactions
n = 1,315
n = 1,312
n = 1,311
n = 1,305
n = 2,258
n = 2,263
Pain
88.4
14.4
82.8
11.1
69.2
8.8
Pain, Grade 3d
10.3
0.5
6.9
0.5
4.0
0.2
Redness
38.7
1.2
38.4
1.6
37.7
1.2
Redness, >100 mm
2.8
0.0
2.6
0.0
3.1
0.0
Swelling
30.5
0.8
26.5
1.0
23.0
1.1
Swelling, >100 mm
1.1
0.0
0.5
0.0
1.3
0.0
General Adverse Events
n = 1,315
n = 1,312
n = 1,309
n = 1,305
n =2,252
n = 2,264
Myalgia
56.9
15.2
49.0
11.2
35.1
9.9
Myalgia, Grade 3e
8.9
0.9
5.3
0.8
2.8
0.4
Fatigue
57.0
19.8
45.7
16.8
36.6
14.4
Fatigue, Grade 3e
8.5
1.8
5.0
0.8
3.5
0.8
Headache
50.6
21.6
39.6
15.6
29.0
11.8
Headache, Grade 3e
6.0
1.7
3.7
0.2
1.5
0.4
Shivering
35.8
7.4
30.3
5.7
19.5
4.9
Shivering, Grade 3e
6.8
0.2
4.5
0.3
2.2
0.3
Fever
27.8
3.0
23.9
3.4
14.3
2.7
Fever, Grade 3f
0.4
0.2
0.5
0.2
0.1
0.1
GIg
24.3
10.7
1 |
