Table 2:
Serious adverse events
| RTS,S/AS01 vaccine (n=99) | Rabies vaccine (n=101) | |
|---|---|---|
|
| ||
| All children | ||
| At least one SAE | 41 (41·4%), 31·6–51·8 | 37 (36·6%), 27·3–46·8 |
| Fatal SAE | 5 (5·1%), 1·7–11·4 | 4 (4·0%), 1·1–9·8 |
| At least one SAE within 30 days after vaccination | 20 (20·2%), 12·8–29·5 | 12 (11·9%), 6·3–19·8 |
| Events reported in all children * | ||
| Blood and lymphatic system disorders | ||
| Anaemia | 1 (1·0%), 0·0–5·5 | 7 (6·9%), 2·8–13·8 |
| Gastrointestinal disorders | ||
| Enteritis | 0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| General disorders and administration site conditions | ||
| Pyrexia | 1 (1·0%), 0·0–5·5 | 0 (0·0%), 0·0–3·6 |
| Hepatobiliary disorders | ||
| Hepatitis | 1 (1·0%), 0·0–5·5 | 0 (0·0%), 0·0–3·6 |
| Infections and infestations | ||
| Abscess | 1 (1·0%), 0·0–5·5 | 0 (0·0%), 0·0–3·6 |
| Amoebiasis | 0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| Bronchiolitis | 0 (0·0%), 0·0–3·7 | 2 (2·0%), 0·2–7·0 |
| Cellulitis | 0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| Gastroenteritis | 21 (21·2%), 13·6–30·6 | 19 (18·8%), 11·7–27·8 |
| Gastroenteritis salmonella |
0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| Helmintic infection | 2 (2·0%), 0·2–7·1 | 0 (0·0%), 0·0–3·6 |
| Malaria | 5 (5·1%), 1·7–11·4 | 10 (9·9%), 4·9–17·5 |
| Measles | 0 (0·0%), 0·0–3·7 | 3 (3·0%), 0·6–8·4 |
| Meningitis haemophilus | 0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| Mycobacterium avium complex infection | 0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| Oral candidosis | 5 (5·1%), 1·7–11·4 | 5 (5·0%), 1·6–11·2 |
| Oropharyngeal candidosis |
0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| Otitis media | 1 (1·0%), 0·0–5·5 | 4 (4·0%), 1·1–9·8 |
| Pneumococcal sepsis | 0 (0·0%), 0·0–3·7 | 3 (3·0%), 0·6–8·4 |
| Pneumocystis jirovecii pneumonia | 1 (1·0), 0·0–5·5 | 0 (0·0%), 0·0–3·6 |
| Pneumonia | 23 (23·2%), 15·3–32·8 | 23 (22·8%), 15·0–32·2 |
| Pulmonary tuberculosis |
2 (2·0%), 0·2–7·1 | 2 (2·0%), 0·2–7·0 |
| Salmonella sepsis | 7 (7·1%), 2·9–14·0 | 6 (5·9%), 2·2–12·5 |
| Sepsis | 0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| Tuberculosis | 2 (2·0%), 0·2–7·1 | 0 (0·0%), 0·0–3·6 |
| Upper-respiratory-tract infection | 0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| Urinary-tract infection | 2 (2·0%), 0·2–7·1 | 2 (2·0%), 0·2–7·0 |
| Varicella | 1 (1·0%), 0·0–5·5 | 0 (0·0%), 0·0–3·6 |
| Viral infection | 0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| Metabolism and nutrition disorders | ||
| Dehydration | 0 (0·0%), 0·0–3·7 | 2 (2·0%), 0·2–7·0 |
| Hypokalaemia | 0 (0·0%), 0·0–3·7 | 1 (1·0%), 0·0–5·4 |
| Kwashiorkor | 1 (1·0%), 0·0–5·5 | 0 (0·0%), 0·0–3·6 |
| Malnutrition | 7 (7·1%), 2·9–14·0 | 5 (5·0%), 1·6–11·2 |
| Nervous system disorders | ||
| Convulsion | 2 (2·0%), 0·2–7·1 | 0 (0·0%), 0·0–3·6 |
| Febrile convulsion | 10 (10·1%), 5·0–17·8 | 13 (12·9%), 7·0–21·0 |
| Respiratory, thoracic, and mediastinal disorders | ||
| Pneumonia aspiration | 1 (1·0%), 0·0–5·5 | 1 (1·0%), 0·0–5·4 |
Data are number of children with an event (%), 95% CI. Data are from the 14·month period after the first vaccine dose in children aged 6 weeks to 17 months at enrolment (the intention-to-treat population). SAE=serious adverse event. n=number of children with at least one administered dose of study drug.
*
Events are listed according to the preferred terms in the Medical Dictionary for Regulatory Activities.