Table 4. Safety and reactogenicity after any vaccination of the safety set.
| Subjects experiencing at least one | Group 1 DTaP-IPV + Hib (n = 203) |
Group 2 DTaP-IPV//Hib (n = 209) |
||
|---|---|---|---|---|
| No. | % (95% CI) | No. | % (95% CI) | |
| Immediate adverse events | 0 | 0 | 0 | 0 |
| Solicited reactions (Days 0-7) - any | 190* | 94.5 (90.4–97.2) | 192 | 91.9 (87.3–95.2) |
| Solicited injection site reaction | 152* | 75.6 (69.1–81.4) | 158 | 75.6 (69.2–81.3) |
| Solicited systemic reaction | 174* | 86.6 (81.8–91.0) | 169 | 80.9 (74.9–86.0) |
| Unsolicited adverse events (Days 8-30) | 148 | 72.9 (66.2–78.9) | 159 | 76.1 (69.7–81.7) |
| Non-serious unsolicited AE | 146 | 71.9 (65.2–78.0) | 157 | 75.1 (68.7–80.8) |
| Non-serious unsolicited systemic AE | 139 | 68.5 (61.6–74.8) | 155 | 74.2 (67.7–80.0) |
| Unsolicited adverse reaction | 18 | 8.9 (5.3–13.7) | 10 | 4.8 (2.3–8.6) |
| Non-serious unsolicited AR | 18 | 8.9 (5.3–13.7) | 10 | 4.8 (2.3–8.6) |
| Non-serious unsolicited injection site AR | 16 | 7.9 (4.6–12.5) | 10 | 4.8 (2.3–8.6) |
| Non-serious unsolicited systemic AR | 2 | 1.0 (0.1–3.5) | 1 | 0.5 (0–2.6) |
| SAE | 12 | 5.9 (3.1–10.1) | 18 | 8.6 (5.2–13.3) |
| AE leading to study discontinuation | 1 | 0.5 (0–2.7) | 0 | 0.0 (0–1.7) |
| Death | 0 | 0 | 0 | 0 |
AE, adverse event; AR, adverse reaction; SAE, serious adverse event; DTaP-IPV, diphtheria-tetanus-acellular pertussis-inactivated polio; Hib, Haemophilus influenzae type b.
*n = 201.