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. Author manuscript; available in PMC: 2024 Sep 1.
Published in final edited form as: Lancet Infect Dis. 2023 May 10;23(9):1062–1071. doi: 10.1016/S1473-3099(23)00139-1

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.