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Table 3 SAEs occurring in more than one subject classified by MedDRA preferred term (Total Vaccinated Cohort [Months 0–20])

From: Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region

 

Hepatitis B vaccine N = 170

RTS,S/AS02D N = 170

Preferred Term

n

%

95% CI

 

n

%

95% CI

 

At least one SAE

62

36.5

29.2

44.2

57

33.5

26.5

41.2

Pneumonia

36

21.2

15.3

28.1

25

14.7

9.7

20.9

P. falciparum infection

25

14.7

9.7

20.9

19

11.2

6.9

16.9

Anaemia

16

9.4

5.5

14.8

16

9.4

5.5

14.8

Gastroenteritis

12

7.1

3.7

12.0

16

9.4

5.5

14.8

Febrile convulsion

2

1.2

0.1

4.2

5

2.9

1.0

6.7

Urinary tract infection

3

1.8

0.4

5.1

4

2.4

0.6

5.9

Lymphadenitis

0

0.0

0.0

2.1

3

1.8

0.4

5.1

Abscess

2

1.2

0.1

4.2

2

1.2

0.1

4.2

Bronchiolitis

1

0.6

0.0

3.2

2

1.2

0.1

4.2

Sepsis

2

1.2

0.1

4.2

2

1.2

0.1

4.2

Upper respiratory tract infection

3

1.8

0.4

5.1

2

1.2

0.1

4.2

Convulsion

2

1.2

0.1

4.2

2

1.2

0.1

4.2

Acarodermatitis

2

1.2

0.1

4.2

0

0.0

0.0

2.1

Bronchial hyperreactivity

3

1.8

0.4

5.1

0

0.0

0.0

2.1

  1. At least one symptom = at least one symptom experienced (regardless of the MedDRA Preferred Term).
  2. N = number of subjects with at least one administered dose.
  3. n/% = number/percentage of subjects reporting at least once the symptom.
  4. 95% CI = exact 95% confidence interval.
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Malaria Journal

ISSN: 1475-2875

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