Table 2 Frequency of adverse events

From: Influenza vaccines promote humoral and cellular immune responses: a randomized, double-blind, phase 3 trial

 

Sinovac-QIV (n=142)

Vaxigrip-TetraTM (n=145)

 
 

N

N° of subjects (%)a

N

N° of subjects (%)b

p valuec

Overall adverse reactions

256

81 (57.0)

271

81 (55.9)

0.141

Grade 1

183

74 (52.1)

200

71 (49.0)

Grade 2

69

36 (25.4)

64

32 (22.1)

Grade 3

4

3 (2.1)

7

5 (3.4)

Total number of reported adverse grade 3 events 28 days of vaccination

10

10 (7.0)

12

12 (8.3)

 

Vaccination site pain

2

2 (1.4)

1

1 (0.7)

 

Headache

3

3 (2.1)

1

1 (0.7)

 

Nausea

1

1 (0.7)

0

0 (0)

 

Muscle pain

0

0 (0)

4

4 (2.8)

 

Fever

0

0 (0)

2

2 (1.4)

 

Fatigue

2

2 (1.4)

3

3 (2.1)

 

Cough

1

1 (0.7)

0

0 (0)

 

Bronchitis

0

0 (0)

1

1 (0.7)

 

Cervicalgia

1

1 (0.7)

0

0 (0)

 
  1. a% with Sinovac-QIV (n = 142).
  2. b% of subjects who presented at least one adverse reaction among the subjects vaccinated with Vaxigrip-TetraTM (n = 145). All tests were two-sided, and p < 0.05 was considered statistically significant.
  3. cX2 test. Some volunteers could have experienced one or more adverse reactions.
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