Table 3.
Occurrence of major adverse reactions after the different injections.
| First safety analysis population |
Second safety analysis population |
||||||
|---|---|---|---|---|---|---|---|
| Vaccine(N = 6000) | Placebo(N = 6000) | Vaccine (N = 5486) | Placebo(N = 5502) | ||||
| % (95% CI) | % (95% CI) | RRa (95% CI) | % (95% CI) | % (95% CI) | RRa (95% CI) | ||
| AR D28 | 28.18 (27.05–29.34) | 18.60 (17.62–19.61) | 1.72 (1.58–1.87) | 16.37 (15.40–17.37) | 11.94 (11.10–12.83) | 1.44 (1.30–1.61) | |
| Solicited AR D7 | 27.75 (26.62–28.90) | 18.23 (17.26–19.23) | 1.72 (1.58–1.88) | 15.97 (15.01–16.96) | 11.67 (10.83–12.55) | 1.44 (1.29–1.60) | |
| Systemic AR D7 | 25.45 (24.35–26.57) | 17.27 (16.32–18.25) | 1.64 (1.50–1.79) | 15.07 (14.14–16.05) | 11.41 (10.59–12.28) | 1.38 (1.23–1.54) | |
| Fever | 20.35 (19.34–21.39) | 12.25 (11.43–13.11) | 1.83 (1.66–2.02) | 12.45 (11.59–13.35) | 9.18 (8.43–9.97) | 1.41 (1.25–1.59) | |
| Diarrhea | 2.95 (2.54–3.41) | 2.87 (2.46–3.32) | 1.03 (0.83–1.27) | 0.93 (0.69–1.22) | 1.13 (0.87–1.44) | 0.82 (0.57–1.19) | |
| ANV | 4.78 (4.26–5.35) | 3.90 (3.42–4.42) | 1.24 (1.04–1.48) | 2.21 (1.83–2.63) | 1.67 (1.35–2.05) | 1.33 (1.01–1.74) | |
| IDF | 3.78 (3.31–4.30) | 2.95 (2.54–3.41) | 1.29 (1.06–1.58) | 1.68 (1.35–2.05) | 1.18 (0.91–1.50) | 1.43 (1.04–1.96) | |
| Allergy | 0.95 (0.72–1.23) | 0.72 (0.52–0.96) | 1.33 (0.89–1.98) | 0.64 (0.44–0.89) | 0.38 (0.24–0.58) | 1.68 (0.97–2.88) | |
| Local AR D7 | 4.77 (4.24–5.34) | 1.95 (1.62–2.33) | 2.52 (2.02–3.13) | 1.86 (1.52–2.25) | 0.51 (0.34–0.73) | 3.70 (2.43–5.64) | |
| Pain | 2.77 (2.37–3.21) | 1.12 (0.87–1.42) | 2.52 (1.89–3.35) | 1.13 (0.87–1.45) | 0.36 (0.22–0.56) | 3.13 (1.89–5.19) | |
| Redness | 1.73 (1.42–2.10) | 0.47 (0.31–0.67) | 3.76 (2.47–5.72) | 0.60 (0.41–0.84) | 0.11 (0.04–0.24) | 5.54 (2.32–13.24) | |
| Pruritus | 0.67 (0.48–0.91) | 0.40 (0.26–0.59) | 1.67 (1.01–2.78) | 0.35 (0.21–0.54) | 0.11 (0.04–0.24) | 3.18 (1.27–7.98) | |
| Swelling | 1.35 (1.07–1.68) | 0.37 (0.23–0.55) | 3.72 (2.32–5.96) | 0.58 (0.40–0.82) | 0.05 (0.01–0.16) | 10.75 (3.29–35.14) | |
| Induration | 0.80 (0.59–1.06) | 0.15 (0.07–0.28) | 5.37 (2.63–10.95) | 0.36 (0.22–0.56) | 0.04 (0.00–0.13) | 10.06 (2.35–43.07) | |
| Unsolicited AR D28 | 1.20 (0.94–1.51) | 0.93 (0.71–1.21) | 1.29 (0.91–1.83) | 0.91 (0.68–1.20) | 0.71 (0.50–0.97) | 1.29 (0.85–1.96) | |
| Cold/RTI | 1.17 (0.91–1.47) | 0.92 (0.69–1.19) | 1.28 (0.89–1.82) | 0.89 (0.66–1.18) | 0.71 (0.50–0.97) | 1.26 (0.83–1.93) | |
RTI: respiratory tract infection; ANV: anorexia/nausea/vomiting; IDF: irritability/drowsiness/fatigue; 95% CI: 95% confidence interval.
Bold numbers means significant relative risk (RR).
a
relative risk compared vaccine group with placebo group.