Table 2.
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.