Table 2 Solicited and unsolicited adverse reactions that occurred within 28 d after vaccination

From: Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial

 

Group A (two doses primed + Convidecia, n = 96)

Group B (two doses primed + CoronaVac, n = 102)

P value

Group C (one dose primed + Convidecia, n = 51)

Group D (one dose primed + CoronaVac, n = 50)

P value

Solicited adverse reactions within 28 d

 

Any

33 (34.4)

5 (4.9)

<0.0001

13 (25.5)

4 (8.0)

0.0188

 

Severe

2 (2.1)

0 (0.0)

0.2338

0 (0.0)

0 (0.0)

–

Injection site adverse reactions

Total

Any

28 (29.2)

3 (2.9)

<0.0001

12 (23.5)

1 (2.0)

0.0012

 

Severe

2 (2.1)

0 (0.0)

0.2338

0 (0.0)

0 (0.0)

–

Pain

Any

25 (26.0)

3 (2.9)

<0.0001

10 (19.6)

1 (2.0)

0.0045

 

Severe

2 (2.1)

0 (0.0)

0.2338

0 (0.0)

0 (0.0)

–

Induration

Any

9 (9.4)

0 (0.0)

0.0012

4 (7.8)

0 (0.0)

0.1176

Redness

Any

12 (12.5)

0 (0.0)

0.0002

5 (9.8)

0 (0.0)

0.0564

Swelling

Any

9 (9.4)

0 (0.0)

0.0012

5 (9.8)

0 (0.0)

0.0564

Itch

Any

10 (10.4)

0 (0.0)

0.0025

5 (9.8)

0 (0.0)

0.0564

Systemic adverse reactions

Total

Any

14 (14.6)

3 (2.9)

0.0035

6 (11.8)

3 (6.0)

0.4874

Fever

Any

4 (4.2)

0 (0.0)

0.0535

3 (5.9)

1 (2.0)

0.6175

Headache

Any

2 (2.1)

0 (0.0)

0.2338

1 (2.0)

0 (0.0)

>0.9999

Fatigue

Any

11 (11.5)

3 (2.9)

0.0195

4 (7.8)

2 (4.0)

0.6779

Diarrhea

Any

0 (0.0)

1 (1.0)

>0.9999

0 (0.0)

0 (0.0)

–

Muscle pain

Any

1 (1.0)

0 (0.0)

0.4848

1 (2.0)

0 (0.0)

>0.9999

Joint pain

Any

1 (1.0)

1 (1.0)

>0.9999

0 (0.0)

0 (0.0)

–

Throat pain

Any

1 (1.0)

1 (1.0)

>0.9999

0 (0.0)

0 (0.0)

–

Cough

Any

0 (0.0)

0 (0.0)

–

1 (2.0)

0 (0.0)

>0.9999

Nausea

Any

0 (0.0)

0 (0.0)

–

1 (2.0)

0 (0.0)

>0.9999

Unsolicited adverse reactions within 28 d

Total

Any

1 (1.0)

0 (0.0)

0.4848

0 (0.0)

0 (0.0)

–

Dizziness

Any

1 (1.0)

0 (0.0)

0.4848

0 (0.0)

0 (0.0)

–

Muscle pain

Any

1 (1.0)

0 (0.0)

0.4848

0 (0.0)

0 (0.0)

–

  1. Data are n (%). n, number of participants; %, proportion of participants; any, all participants with any grade of adverse reactions or event. The analysis was based on the intervention modified intention-to-treat cohort. P values shown in bold are <0.05.
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