Table 3.
Frequency of adverse reactions within 14 days after the first booster dose of rabies vaccine in the safety-set (SS) population
| Adverse Reaciona | Kanghua vaccine group |
Pasteur vaccine group |
P Value | |||
|---|---|---|---|---|---|---|
| Group A (n = 61) | Group B (n = 65) | Group C (n = 37) | Group D (n = 79) | Group E (n = 82) | ||
| Injection-site reaction | ||||||
| Pain | ||||||
| Participants, No. | 4 | 2 | 2 | 7 | 11 | |
| Participants, %(95% CI) | 6.56(1.82–15.95) | 3.08(0.37–10.68) | 5.41(0.66–18.19) | 8.86(3.64–17.41) | 13.41(6.89–22.74) | .2006 |
| Induration | ||||||
| Participants, No. | 0 | 0 | 0 | 1 | 0 | |
| Participants, %(95% CI) | 0(0.00–5.87) | 0(0.00–5.52) | 0(0.00–9.49) | 1.27(0.03–6.85) | 0(0.00–4.40) | .7469 |
| Itch | ||||||
| Participants, No. | 0 | 0 | 1 | 0 | 0 | |
| Participants, %(95% CI) | 0(0.00–5.87) | 0(0.00–5.52) | 2.70(0.07–14.16) | 0(0.00–4.56) | 0(0.00–4.40) | .1142 |
| Overall | ||||||
| Participants, No. | 4 | 2 | 3 | 8 | 11 | |
| Participants, %(95% CI) | 6.56(1.82–15.95) | 3.08(0.37–10.68) | 8.11(1.70–21.91) | 10.13(4.47–18.98) | 13.41(6.89–22.74) | .2410 |
| Systemic reaction | ||||||
| Feverb | ||||||
| Participants, No. | 0 | 1 | 0 | 2 | 7 | |
| Participants, %(95% CI) | 0(0.00–5.87) | 1.54(0.04–8.28) | 0(0.00–9.49) | 2.53(0.31–8.85) | 8.54(3.50–16.80) | .0329 |
| Muscle pain | ||||||
| Participants, No. | 0 | 0 | 0 | 1 | 0 | |
| Participants, %(95% CI) | 0(0.00–5.87) | 0(0.00–5.52) | 0(0.00–9.49) | 1.27(0.03–6.85) | 0(0.00–4.40) | .7469 |
| Fatigue | ||||||
| Participants, No. | 0 | 0 | 0 | 0 | 1 | |
| Participants, %(95% CI) | 0(0.00–5.87) | 0(0.00–5.52) | 0(0.00–9.49) | 0(0.00–4.56) | 1.22(0.03–6.61) | 1.0000 |
| Overall | ||||||
| Participants, No. | 0 | 1 | 0 | 3 | 7 | |
| Participants, %(95% CI) | 0(0.00–5.87) | 1.54(0.04–8.28) | 0(0.00–9.49) | 3.80(0.79–10.70) | 8.54(3.50–16.80) | .0406 |
aSeverity grades were defined as follows, unless otherwise indicated: grade 1, mild (ie, no interference with activity); grade 2, moderate (ie, some interference with activity); grade 3, severe (ie, prevented activity).
bGrade 1, axillary temperature of 37.1°C–37.5°C; grade 2, axillary temperature of 37.6°C–39.0°C; grade 3: axillary temperature of ≥39.1°C.
Abbreviation: CI, confidence interval.
The safety-set (SS) Population was defined as participants who had received at least one booster dose and have at least one safety information in this complementary clinical trial at 10 year later.