Table 4:
Adverse events reported in participants during the study, by study group
nOPV2 only group (n=264) | nOPV2 plus bOPV group (n=265) | bOPV only group (n=266) | |
---|---|---|---|
| |||
Any adverse event | 24 (9%) | 17 (6%) | 20 (8%) |
Any serious adverse event | 5 (2%) | 4 (2%) | 6 (2%) |
Unsolicited adverse events | |||
Any | 17 (6%) | 16 (6%) | 16 (6%) |
Acute respiratory infections | 6 (2%) | 8 (3%) | 7 (3%) |
Acute diarrhoea and gastroenteritis | 4 (2%) | 4 (2%) | 3 (1%) |
Pneumonia | 5 (2%) | 3 (1%) | 2 (1%) |
Death, SIDS | 1 (<1%) | 1 (<1%) | 1 (<1%) |
Cardiomyopathy | 0 | 0 | 1 (<1%) |
Dengue | 0 | 0 | 1 (<1%) |
Fever | 0 | 0 | 1 (<1%) |
Malnutrition | 0 | 1 (<1%) | 0 |
Oral thrush | 1 (<1%) | 0 | 0 |
Solicited adverse events | |||
Any | 7 (3%) | 1 (<1%) | 5 (2%) |
Fever | 5 (2%) | 1 (<1%) | 4 (2%) |
Abnormal crying | 0 | 1 (<1%) | 1 (<1%) |
Vomiting | 1 (<1%) | 0 | 1 (<1%) |
Poor feeding | 1 (<1%) | 0 | 0 |
Other (diarrhoea) | 1 (<1%) | 0 | 0 |
Irritability | 0 | 0 | 0 |
Drowsiness | 0 | 0 | 0 |
Data are n (%). bOPV=bivalent oral poliovirus vaccine. nOPV2=novel oral poliovirus vaccine type 2. SIDS=sudden infant death syndrome.