Table 4.
Serious adverse events coded by MedDRA system organ classification and preferred terms
| Vaccine N=4531 n (%) |
Placebo N=2265 n (%) |
P value | |
|---|---|---|---|
| Children who had an SAE | 925 (20·3) | 499 (22·0) | 0·13 |
| Infections and infestations | 777 (17·1) | 418 (18·5) | 0·19 |
| Lower respiratory tract infection | 261 (5·8) | 124 (5·5) | 0·66 |
| Gastroenteritis | 221 (4·9) | 109 (4·8) | 0·95 |
| Gastroenteritis Rotavirus | 77 (1·7) | 69 (3·0) | <0·001 |
| Bronchopneumonia | 76 (1·7) | 38 (1·7) | 1·00 |
| Pneumonia | 60 (1·3) | 21 (0·9) | 0·19 |
| Respiratory, thoracic and mediastinal disorders | 129 (2·8) | 71 (3·1) | 0·54 |
| Wheezing | 106 (2·3) | 54 (2·4) | 0·93 |
| General disorders and administration site conditions | 72 (1·6) | 33 (1·5) | 0·75 |
| Pyrexia | 62 (1·4) | 29 (1·3) | 0·82 |