Table 2 Overall adverse events in the Safety Set and in the two age groups after each vaccination

From: A randomized trial comparing safety, immunogenicity and efficacy of self-amplifying mRNA and adenovirus-vector COVID-19 vaccines

  

Total

18–59 year-olds

≥60 year-olds

Parameter

 

ARCT-154 N = 1186

ChAdOx1-S N = 1180

ARCT-154 N = 859

ChAdOx1-S N = 855

ARCT-154 N = 327

ChAdOx1-S N = 325

Death, n (%)

 

0

4

0

3

0

1

 

0

(0.3%)

0

(0.4%)

0

(0.3%)

Serious adverse events (SAE), n (%)a

 

83

87

44

54

39

33

 

(7.0)

(7.4)

(5.1)

(6.3)

(11.9)

(10.2)

Related to vaccination

 

3

4

1

3

2

1

 

(0.3)

(0.3)

(0.1)

(0.4)

(0.6)

(0.3)

Led to withdrawal from study vaccination

 

2

1

1

1

1

0

 

(0.2)

(0.1)

(0.1)

(0.1)

(0.3)

(0)

COVID-19

 

8

9

5

8

3

1

 

(0.7)

(0.8)

(0.6)

(0.9)

(0.9)

(0.3)

Medically-attended adverse events (MAAE), n (%)a

 

461

496

321

356

140

140

 

(38.9)

(42.0)

(37.4)

(41.6)

(42.8)

(43.1)

Related to vaccination

 

19

23

15

19

4

4

 

(1.6)

(1.9)

(1.7)

(2.2)

(1.2)

(1.2)

Severe

 

25

31

12

21

13

10

 

(2.1)

(2.6)

(1.4)

(2.5)

(4.0)

(3.1)

 

Dose 1b

n = 1186

n = 1180

n = 859

n = 855

n = 327

n = 325

 

Dose 2b

n = 1171

n = 1167

n = 851

n = 846

n = 320

n = 321

Solicited local reactions, n (%)c

Dose 1

467

416

371

330

96

86

 

(39.5)

(35.4)

(43.2)

(38.8)

(29.6)

(26.5)

Dose 2

286

183

234

140

52

43

 

(24.9)

(15.9)

(28.1)

(16.9)

(16.4)

(13.4)

Solicited systemic adverse events, n (%)c

Dose 1

638

657

465

502

173

155

 

(54.0)

(55.9)

(54.2)

(59.0)

(53.4)

(47.7)

Dose 2

477

331

347

241

130

90

 

(41.5)

(28.8)

(41.7)

(29.1)

(40.9)

(28.0)

Unsolicited adverse events, n (%)d

Dose 1

260

252

180

175

80

77

 

(21.9)

(21.4)

(21.0)

(20.5)

(24.5)

(23.7)

Severe

2

3

1

1

1

2

 

(0.2)

(0.3)

(0.1)

(0.1)

(0.3)

(0.6)

Dose 2

226

225

165

153

61

72

 

(19.3)

(19.3)

(19.4)

(18.1)

(19.1)

(22.4)

Severe

1

5

0

3

1

2

 

(0.1)

(0.4)

(0)

(0.4)

(0.3)

(0.6)

  1. Actual values are in bold, rather than percentage values.
  2. aSAE and MAAE occurring at any time during the study.
  3. bNumbers of participants who provided completed diary cards.
  4. cSolicited local reactions and systemic adverse events in the 7 days after each vaccination.
  5. dUnsolicited adverse events in the 28 days after each vaccination.
Back to article page