Table 3.
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 infants
|
Monovalent OPV2 |
Novel OPV2-c1 |
Novel OPV2-c2 |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Standard dose |
Low dose |
High dose |
Low dose |
High dose |
|||||||
| Dose 1 (n=110) | Dose 2 (n=48) | Dose 1 (n=138) | Dose 2 (n=51) | Dose 1 (n=150) | Dose 2 (n=49) | Dose 1 (n=135) | Dose 2 (n=49) | Dose 1 (n=151) | Dose 2 (n=50) | ||
| Serious adverse events | 1 (1%) | 0 | 1 (1%) | 1 (2%) | 6 (4%) | 1 (2%) | 2 (1%) | 1 (2%) | 9 (6%) | 1 (2%) | |
| Vaccine-related serious adverse events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Important medical events | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Vaccine-related important medical events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Solicited adverse events | |||||||||||
| Any | 29 (26%) | 7 (15%) | 37 (27%) | 13 (25%) | 49 (33%) | 14 (29%) | 42 (31%) | 13 (27%) | 52 (34%) | 12 (24%) | |
| Grade 1 | 21 (19%) | 6 (13%) | 24 (17%) | 6 (12%) | 20 (13%) | 6 (12%) | 29 (21%) | 10 (20%) | 36 (24%) | 10 (20%) | |
| Grade 2 | 6 (5%) | 1 (2%) | 12 (9%) | 7 (14%) | 28 (19%) | 8 (16%) | 12 (9%) | 3 (6%) | 15 (10%) | 2 (4%) | |
| Grade 3 | 2 (2%) | 0 | 1 (1%) | 0 | 1 (1%) | 0 | 1 (1%) | 0 | 1 (1%) | 0 | |
| Causally associated (adverse reactions) | 14 (13%) | 5 (10%) | 35 (25%) | 12 (24%) | 46 (31%) | 11 (22%) | 37 (27%) | 11 (22%) | 45 (30%) | 12 (24%) | |
| Unsolicited adverse events | |||||||||||
| Any | 74 (67%) | 33 (69%) | 70 (51%) | 30 (59%) | 94 (63%) | 33 (67%) | 89 (66%) | 29 (59%) | 96 (64%) | 30 (60%) | |
| Causally associated | 1 (1%) | 0 | 0 | 0 | 2 (1%) | 0 | 0 | 0 | 0 | 1 (2%) | |
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.