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. 2021 Jan 2;397(10268):27–38. doi: 10.1016/S0140-6736(20)32540-X

Table 2.

Occurrence of solicited adverse events within 7 days, and serious adverse events, important medical events, and unsolicited adverse events within 30 days of first or second vaccinations in children

Monovalent OPV2
Novel OPV2-c1 (high dose)
Novel OPV2-c2 (high dose)
Dose 1 (n=50) Dose 2 (n=47) Dose 1 (n=47) Dose 2 (n=45) Dose 1 (n=53) Dose 2 (n=52)
Serious adverse events 0 1 (2%) 0 1 (2%) 1 (2%) 0
Vaccine-related serious adverse events 0 0 0 0 0 0
Important medical events 0 0 1 (2%) 0 0 0
Vaccine-related important medical events 0 0 0 0 0 0
Solicited adverse events
Any 10 (20%) 9 (19%) 17 (36%) 12 (27%) 14 (26%) 12 (23%)
Grade 1 9 (18%) 7 (15%) 13 (28%) 10 (22%) 8 (15%) 10 (19%)
Grade 2 0 2 (4%) 3 (6%) 1 (2%) 3 (6%) 1 (2%)
Grade 3 1 (2%) 0 1 (2%) 1 (2%) 3 (6%) 1 (2%)
Causally associated (adverse reactions) 1 (2%) 0 5 (11%) 10 (22%) 4 (8%) 4 (8%)
Unsolicited adverse events
Any 37 (74%) 24 (51%) 35 (74%) 32 (71%) 41 (77%) 42 (81%)
Causally associated 0 0 1 (2%) 0 0 0

No serious adverse events or important medical events were considered to be serious adverse reactions or important medical reactions (ie, causally associated with vaccination). OPV2=type 2 oral poliovirus vaccine.