Adverse events | Incidence (per 100 children) | RRa (95% CI) | ||
---|---|---|---|---|
First dose N = 373 | Second dose N = 372 | Third dose N = 374 | ||
Swelling | 79(44.6) | 50(28.2) | 48(27.1) | 0.72(0.59–0.89) |
Redness | 50(40.7) | 30(24.4) | 43(35) | 0.9(0.72–1.14) |
Pain | 190(38.4) | 143(28.9) | 162(32.7) | 0.85(0.74–0.99) |
Mild fever | 45(31.9) | 33(23.4) | 63(44.7) | 1.24(1.00–1.54) |
High fever | 1(100) | 0(0) | 0(0) | NA |
Drowsiness | 83(36.9) | 72(32) | 70(31.1) | 0.89(0.74–1.07) |
Anorexia | 65(38.7) | 51(30.4) | 52(31) | 0.87(0.71–1.06) |
Restlessness | 135(36.6) | 115(31.2) | 119(32.2) | 0.9(0.77–1.05) |
Vomiting | 16(30.8) | 19(36.5) | 17(32.7) | 1.02(0.73–1.44) |
Long-term crying | 24(38.7) | 16(25.8) | 22(35.5) | 0.94(0.69–1.29) |
Encephalopathy | 0(0) | 0(0) | 0(0) | Not applicable |
Convulsion | 0(0) | 0(0) | 0(0) | Not applicable |
History of convulsion | 0(0) | 1(0.2) | 2(0.5) | 3.45(0.5–23.74) |
Family history of convulsion | 0(0) | 14(3.7) | 6(1.6) | 1.6(0.9–2.83) |