Table 3 The frequency of adverse events in each group of the bSS.

From: A phase 3 clinical trial on the immunogenicity and safety of booster vaccination after Zagreb or Essen regimens

n (%)

Group B

N = 196

Group C

N = 190

Group E

N = 190

Group F

N = 184

*P-value

AEs

23 (11.73%)

32 (16.84%)

10 (5.26%)

23 (12.5%)

0.0035

ARs

22 (11.22%)

30 (15.79%)

7 (3.68%)

20 (10.87%)

0.0007

Inject-site AEs

18 (9.18%)

23 (12.11%)

6 (3.16%)

17 (9.24%)

0.0080

 Pain

16 (8.16%)

23 (12.11%)

6 (3.16%)

17 (9.24%)

 

 Induration

0

1 (0.53%)

0

0

 

 Redness

1 (0.51%)

2 (1.05%)

1 (0.53%)

0

 

 Swelling

0

2 (1.05%)

1 (0.53%)

4 (2.17%)

 

 Itch

3 (1.53%)

0

1 (0.53%)

1 (0.54%)

 

 Rash

0

0

0

0

 

Systemic AEs

9 (4.59%)

11 (5.79%)

3 (1.58%)

6 (3.26%)

0.1461

 Fever

5 (2.55%)

6 (3.16%)

2 (1.05%)

3 (1.63%)

 

 Fatigue

3 (1.53%)

5 (2.63%)

0

2 (1.09%)

 

 Headache

1 (0.51%)

1 (0.53%)

1 (0.53%)

2 (1.09%)

 

 Dizziness

1 (0.51%)

3 (1.58%)

0

2 (1.09%)

 

 Vomiting

0

1(0.53%)

0

0

 

 Bellyache

0

2 (1.05%)

0

0

 

 Diarrhea

0

1 (0.53%)

0

0

 

 Myalgia

2 (1.02%)

1 (0.53%)

0

0

 

 Arthralgia

0

0

0

0

 

 Acute allergic reaction

0

0

0

0

 
  1. The booster safety set (bSS) included the participants receiving at least one booster.
  2. *P-value from the comparison of all four groups.
  3. All solicited adverse events (AEs), including injection-site-associated AEs and systemic AEs, were defined as adverse reactions (ARs) in this study, according to the judgement of professional investigators.