AE type | TVC (N = 155) | |
---|---|---|
n | % (95% CI) | |
≥1 AE(s) | 41 | 26.5 (19.7, 34.1) |
≥1 Grade 3 AE(s) | 3 | 1.9 (0.4, 5.6) |
≥1 AE(s) causally related to vaccination Causal relationship with vaccination based on the medical assessment by the investigator | 3 | 1.9 (0.4, 5.6) |
≥1 MAE(s) | 36 | 23.2 (16.8, 30.7) |
≥1 SAE(s) | 2 | 1.3 (0.2, 4.6) |
≥1 pIMD | 0 | – |
Solicited symptom | TVC Includes all children who received at least one dose of vaccine for whom diary cards of solicited events were available | |||||||
---|---|---|---|---|---|---|---|---|
% | % | |||||||
Pain | 111 | 72.1 (64.3, 79.0) | 8 | 5.2 (2.3, 10.0) | ||||
Redness | 6 | 3.9 (1.4, 8.3) | 0 | 0.0 (0.0, 2.4) | ||||
Swelling | 5 | 3.2 (1.1, 7.4) | 0 | 0.0 (0.0, 2.4) | ||||
< | ||||||||
% | % | % | % | |||||
Drowsiness | 23 | 29.1 (19.4, 40.4) | 1 | 1.3 (0.0, 6.9) | – | – | ||
Irritability/fussiness | 28 | 35.4 (25.0, 47.0) | 1 | 1.3 (0.0, 6.9) | – | – | ||
Loss of appetite | 18 | 22.8 (14.1, 33.6) | 0 | 0.0 (0.0, 4.6) | – | – | ||
Increased temperature | 4 | 5.1 (1.4, 12.5) | 2 | 2.5 (0.3, 8.8) ≥39°C | 1 | 1.3 (0.0, 7.2) | 0 | 0.0 (0.0, 4.8) ≥39°C |
Fatigue | – | – | 18 | 24.0 (14.9, 35.3) | 1 | 1.3 (0.0, 7.2) | ||
Gastrointestinal disorder | – | – | 7 | 9.3 (3.8, 18.3) | 0 | 0.0 (0.0, 4.8) | ||
Headache | – | – | 24 | 32.0 (21.7, 43.8) | 1 | 1.3 (0.0, 7.2) | ||
Increased sweating | – | – | 5 | 6.7 (2.2, 14.9) | 0 | 0.0 (0.0, 4.8) | ||
Joint pain | – | – | 14 | 18.7 (10.6, 29.3) | 0 | 0.0 (0.0, 4.8) | ||
Muscle aches | – | – | 34 | 45.3 (33.8, 57.3) | 0 | 0.0 (0.0, 4.8) | ||
Shivering (chills) | – | – | 7 | 9.3 (3.8, 18.3) | 2 | 2.7 (0.3, 9.3) |