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Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed
in the clinical studies of a vaccine cannot be directly compared to rates in the clinical studies of another
vaccine and may not reflect the rates observed in clinical practice.
A US study (Study 1) included 1,357 subjects for safety analysis (1,359 enrolled), ages 18 to
less than 65 years, randomized to receive Afluria® (1,089 subjects) or placebo (268 subjects)
(see full for study demographics).
No deaths or serious adverse events were reported in this study.
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A UK study (Study 2) included 275 subjects, ages 65 years and older, randomized to receive
preservative-free Afluria® (206 subjects) or a European-licensed trivalent inactivated influenza
vaccine as an active control (69 subjects) (for more information see
). No deaths or serious adverse events
reported in this study.
The safety assessment was identical for the two studies. Local (injection-site) and
systemic adverse events were solicited by completion of a symptom diary card for 5 days post-vaccination
(Table 1). Unsolicited local and systemic adverse events were collected for 21 days post-vaccination
(Table 2). These unsolicited adverse events were reported either spontaneously or when subjects were
questioned about any change to their health post-vaccination. All adverse events are presented
regardless of any treatment causality assigned by study investigators.
Table 1: Proportion of Subjects With Solicited Local or Systemic Adverse Events* Within 5 days After Administration of
Afluria® or Placebo, Irrespective of Causality
|
|
Study 1
Adults ≥18 to <65 Years |
Study 2
Adults ≥65 Years |
|
Solicited Adverse event |
Afluria®‡
n=1089 |
Placebo§
n=268 |
Afluria®
n=206 |
|
Local |
|
|
|
|
Tenderness|| |
60% |
18% |
34% |
|
Pain||¶ |
40% |
9% |
9% |
|
Redness |
16% |
8% |
23% |
|
Swelling |
9% |
1% |
11% |
|
Bruising |
5% |
1% |
4% |
|
Systemic |
|
|
|
|
Headache |
26% |
26% |
15% |
|
Malaise |
20% |
19% |
10% |
|
Muscle aches |
13% |
9% |
14% |
|
Nausea |
6% |
9% |
3% |
|
Chills/Shivering |
3% |
2% |
7% |
|
Fever ≥37.7°C (99.86°F) |
1% |
1% |
1% |
|
Vomiting |
1% |
1% |
0% |
*In Study 1, 87% of solicited local and systemic adverse events were mild, 12% were
moderate, and 1% were severe. In Study 2, 76.5% were mild, 20.5% were moderate,
and 3% were severe. In both studies, most solicited local and systemic adverse events
lasted not longer than 2 days.
†Values rounded to the nearest whole percent.
‡ Includes subjects who received either the single-dose (preservative-free)
or multi-dose formulation of Afluria®.
§Thimerosal-containing placebo.
||Tenderness defined as pain on touching.
¶Pain defined as spontaneously painful without touch.
Table 2: Unsolicited Adverse Events* Reported Spontaneously by ≥1% of Subjects Within 21 Days
After Administration of Afluria®or Placebo, Irrespective of Causality
|
|
Study 1
Adults ≥18 to <65 Years |
Study 2
Adults ≥65 Years |
|
Adverse event |
Afluria®‡
n=1089 |
Placebo§
n=268 |
Afluria®
n=206 |
|
Headache |
8%§ |
6% |
8% |
|
Nasal Congestion |
1% |
1% |
7% |
|
Cough |
1% |
0.4% |
5% |
|
Rhinorrhea |
1% |
1% |
5% |
Pharyngolaryngeal
Pain |
3% |
1% |
5% |
|
Reactogenicity Event |
3% |
3% |
0% |
|
Diarrhea |
2% |
3% |
1% |
|
Back Pain |
2% |
0.4%|| |
2% |
Upper Respiratory
Tract Infection |
2% |
1% |
0.5% |
|
Viral Infection |
0.4% |
1% |
0% |
Lower Respiratory
Tract Infection |
0% |
0% |
1% |
|
Myalgia |
1% |
1% |
1% |
|
Muscle Spasms |
0.4% |
1% |
0% |
*In Study 1, 63% of unsolicited adverse events were mild, 35% were moderate, and 2%
were severe. In Study 2, 47% were mild, 51% were moderate, and 3% were severe. In
both studies, most unsolicited adverse events lasted no longer than 5 days.
†Values greater than 0.5% rounded to the nearest whole percent.
‡†Includes subjects who received either the single-dose (preservative-free) or multi-dose
formulation of Afluria®.
§‡Thimerosal-containing placebo.