Table 3.
Summary of adverse events and subjects with adverse events.
| cIPV-tOPV-tOPV (n = 100) | cIPV-cIPV-cIPV (n = 99) | cIPV-bOPV-bOPV (n = 100) | tOPV-tOPV-tOPV (n = 101) | cIPV-cIPV-tOPV (n = 100) | cIPV-cIPV-bOPV (n = 100) | Total (n = 600) | |
|---|---|---|---|---|---|---|---|
| Serious adverse events | |||||||
| Number of AEs | 4 | 4 | 7 | 1 | 4 | 8 | 28 |
| Number of subjects with AEs (n/N%) | 4 (4.00%) | 3 (3.03%) | 5 (5.00%) | 1 (0.99%) | 4 (4.00%) | 7 (7.00%) | 24 (4.00%) |
| Systemic reactions* | |||||||
| Number of AEs | 248 | 256 | 242 | 239 | 289 | 257 | 1531 |
| Number of subjects with AEs (n/N%) | 83 (83.00%) | 76(76.77%) | 78 (78.00%) | 78 (77.23%) | 90 (90.00%) | 90 (90.00%) | 495 (82.50%) |
| Fever | |||||||
| Number of AEs | 186 | 188 | 173 | 170 | 202 | 180 | 1099 |
| Number of subjects with AEs (n/N%) | 80 (80.00%) | 70 (70.71%) | 71 (71.00%) | 75 (74.26%) | 86 (86.005) | 85 (85.00%) | 467 (77.83%) |
| Irritability/fussiness | |||||||
| Number of AEs | 10 | 16 | 13 | 15 | 20 | 20 | 94 |
| Number of subjects with AEs (n/N%) | 8 (8.005) | 10 (10.00%) | 9 (9.00%) | 11 (10.89%) | 15 (15.00%) | 13 (13.00%) | 66 (11.00%) |
| Somnolence | |||||||
| Number of AEs | 3 | 3 | 2 | 3 | 2 | 2 | 15 |
| Number of subjects with AEs (n/N%) | 3 (3.00%) | 3 (3.03%) | 2 (2.00%) | 2 (2.97%) | 2 (2.00%) | 2 (2.00%) | 15 (2.50%) |
| Vomit | |||||||
| Number of AEs | 7 | 7 | 8 | 3 | 14 | 3 | 42 |
| Number of subjects with AEs (n/N%) | 6 (6.00%) | 7 (7.07%) | 7 (7.00%) | 2 (2.97%) | 9 (9.00%) | 3 (3.00%) | 35 (5.83%) |
| Diarrhea | |||||||
| Number of AEs | 42 | 42 | 45 | 46 | 46 | 47 | 268 |
| Number of subjects with AEs (n/N%) | 34 (34.00%) | 28 (28.28%) | 31 (31.00%) | 29 (28.71%) | 29 (29.00%) | 29 (29.00%) | 180 (30.00%) |
| Allergic reaction | |||||||
| Number of AEs | 0 | 0 | 1 | 2 | 5 | 5 | 13 |
| Number of subjects with AEs (n/N%) | 0 | 0 | 1 (1.00%) | 1 (0.99%) | 5 (5.00%) | 5 (5.00%) | 12 (2.00%) |
| Local reaction: Redness on injection site | |||||||
| Number of AEs | 1 | 3 | 2 | 0 | 4 | 2 | 12 |
| Number of subjects with AEs (n/N%) | 1 (1.00%) | 3 (3.03%) | 2 (2.00%) | 0 | 3 (3.00%) | 2 (2.00%) | 11 (1.83%) |
*
Systemic reactions involve fever, easy irritation, somnolence, vomit, diarrhea and allergic reaction.
cIPV = conventional inactivated poliovirus vaccine. bOPV = bivalent oral poliovirus vaccine. tOPV = trivalent oral poliovirus vaccine.