Systemic event | Dose | Prophylaxis group % (n/N) | Control group % (n/N) | p-value* |
---|---|---|---|---|
Fever | Dose 1 | 9.3 (11/118) | 35.8 (48/134) | <0.001 |
≥38°C to ≤39°C | Dose 2 | 19.7 (24/122) | 43.7 (55/126) | 0.000 |
Dose 3 | 19.3 (21/109) | 45.6 (52/114) | 0.000 | |
Toddler dose | 51.5 (53/103) | 60.0 (69/115) | 0.221 | |
>39°C to ≤40°C | Dose 1 | 0 | 4.0 (5/124) | 0.061 |
Dose 2 | 0 | 1.8 (2/112) | 0.238 | |
Dose 3 | 1.0 (1/102) | 1.9 (2/103) | >0.99 | |
Toddler dose | 4.6 (4/87) | 13.1 (13/99) | 0.072 | |
>40°C † | Toddler dose | 0 | 1.1 (1/95) | >0.99 |
Rash | Dose 1 | 17.6 (21/119) | 17.1 (22/129) | >0.99 |
Dose 2 | 6.8 (8/118) | 15.7 (19/121) | 0.040 | |
Dose 3 | 12.7 (14/110) | 22.4 (24/107) | 0.074 | |
Toddler dose | 13.3 (12/90) | 23.6 (25/106) | 0.098 | |
Irritability | Dose 1 | 47.2 (59/125) | 62.1 (87/140) | 0.019 |
Dose 2 | 42.2 (54/128) | 58.5 (76/130) | 0.013 | |
Dose 3 | 39.7 (48/121) | 50.0 (59/118) | 0.120 | |
Toddler dose | 48.2 (53/110) | 60.5 (75/124) | 0.066 | |
Drowsiness | Dose 1 | 50.4 (65/129) | 64.7 (90/139) | 0.019 |
Dose 2 | 46.5 (59/127) | 58.3 (74/127) | 0.078 | |
Dose 3 | 36.4 (43/118) | 45.6 (52/114) | 0.182 | |
Toddler dose | 43.5 (47/108) | 50.4 (59/117) | 0.350 | |
Decreased appetite | Dose 1 | 30.3 (37/122) | 40.0 (54/135) | 0.118 |
Dose 2 | 26.6 (33/124) | 42.7 (53/124) | 0.011 | |
Dose 3 | 23.0 (26/113) | 33.6 (37/110) | 0.101 | |
Toddler dose | 38.2 (39/102) | 45.2 (52/115) | 0.336 | |
Persistent inconsolable crying | Dose 1 | 9.5 (11/116) | 20.0 (26/130) | 0.031 |
Dose 2 | 9.3 (11/118) | 15.8 (19/120) | 0.171 | |
Dose 3 | 14.0 (15/107) | 15.3 (17/111) | 0.849 | |
Toddler dose | 7.8 (7/90) | 17.1 (18/105) | 0.056 | |
Decreased activity | Dose 1 | 41.6 (52/125) | 46.3 (63/136) | 0.457 |
Dose 2 | 31.0 (39/126) | 48.0 (60/125) | 0.007 | |
Dose 3 | 23.3 (27/116) | 40.0 (46/115) | 0.007 | |
Toddler dose | 29.0 (29/100) | 48.3 (56/116) | 0.005 |