Table 2 Number of participants with at least 1 solicited local or general AEs within 7 days of vaccination (cumulative over month 0, month 1, and month 2)

From: A randomised trial of malaria vaccine R21/Matrix-M™ with and without antimalarial drugs in Thai adults

Safety parameter

Group 1 n = 50

Group 2 n = 50

Group 3 n = 20

Total n = 120

Solicited local and general AEs within seven days: n(%), (95% CI)

37 (74), (59.7, 85.4)

36 (72), (57.5, 83.8)

0

73 (60.8), (51.5, 69.6)

Unsolicited AEs: date of 1st vaccine to 28 days after last vaccine: n(%), (95% CI)

17 (34.0), (21.2, 48.8)

6 (12.0), (4.5, 24.3)

4 (20.0), (5.7, 43.7)

27 (22.5), (15.4, 31)

SAEs within 28 days after each vaccine: n(%), (95% CI)

1 (2.0), (0.1, 10.6)

0

1 (5.0), (0.1, 24.9)

2 (1.7), (0.2, 5.9)

SAEs for whole period: n(%), (95% CI)

1 (2.0), (0.1, 10.6)

0

1 (5.0), (0.1, 24.9)

2 (1.7), (0.2, 5.9)

AEs or SAEs leading to withdrawal from further vaccination from Dose 1 to study conclusion: n(%), (95% CI)

0

0

0

0

pIMDs from Dose 1 to study conclusion: n(%), (95% CI)

0

0

1 (5.0), (0.1, 24.9)

1 (0.8), (0.0, 4.6)

Meningitis from Dose 1 to study conclusion: n(%), (95% CI)

0

0

0

0

  1. Group 1 = R21/Matrix-M™ + DHA-PIP + SLD-PQ n = 50, Group 2 = R21/Matrix-M™ n = 50, Group 3 = No vaccine n = 20.
  2. AE adverse event, SAE serious adverse event, pIMD potential immune mediated disorder.
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