Table 2.
Cochrane-Armitage age trend test for major adverse reactions in the vaccine and placebo groups.
| 6–11 months | 12–23 months | 24–35 months | 36–71 months | |||
|---|---|---|---|---|---|---|
| Vaccine | n (%) | n (%) | n (%) | n (%) | Z | P |
| N | 1750 | 1750 | 1500 | 1000 | ||
| AR D28 | 741 (42.34) | 704 (40.23) | 461 (30.73) | 289 (28.90) | −8.654 | <0.001*** |
| Solicited AR D7 | 735 (42.00) | 691 (39.49) | 456 (30.40) | 279 (27.9) | −8.914 | <0.001*** |
| Systemic AR D7 | 708 (40.46) | 665 (38.00) | 422 (28.13) | 227 (22.70) | −10.868 | <0.001*** |
| Fever | 569 (32.51) | 562 (32.11) | 351 (23.40) | 186 (18.60) | −9.040 | <0.001*** |
| Diarrhea | 99 (5.66) | 70 (4.00) | 40 (2.67) | 10 (1.00) | −6.682 | <0.001*** |
| ANV | 153 (8.74) | 125 (7.14) | 67 (4.47) | 31 (3.10) | −6.718 | <0.001*** |
| IDF | 143 (8.17) | 86 (8.17) | 37 (2.47) | 27 (2.70) | −7.769 | <0.001*** |
| Allergy | 35 (2.00) | 23 (1.31) | 20 (1.33) | 12 (1.20) | −1.729 | 0.084 |
| Local AR D7 | 111 (6.34) | 74 (4.23) | 75 (5.00) | 92 (9.2) | 2.350 | 0.019* |
| Pain | 41 (2.34) | 39 (2.23) | 48 (3.20) | 82 (8.20) | 7.274 | <0.001*** |
| Redness | 63 (3.60) | 34 (1.94) | 18 (1.20) | 14 (1.40) | −4.59 | <0.001*** |
| Pruritus | 11 (0.63) | 15 (0.86) | 16 (1.07) | 16 (1.60) | 2.500 | 0.012* |
| Swelling | 54 (3.09) | 20 (1.14) | 19 (1.27) | 12 (1.20) | −3.867 | 0.001** |
| Induration | 34 (1.94) | 13 (0.74) | 10 (0.67) | 6 (0.60) | −3.630 | 0.003** |
| Unsolicited AR D28 | 30 (1.71) | 40 (2.29) | 18 (1.20) | 34 (3.40) | 1.762 | 0.078 |
| Cold/RTI | 30 (1.71) | 39 (2.23) | 18 (1.20) | 32 (3.20) | 1.511 | 0.131 |
| Placebo | ||||||
| N | 1750 | 1750 | 1500 | 1000 | ||
| AR D28 | 509 (29.09) | 482 (27.54) | 375 (25.00) | 217 (21.70) | −4.470 | <0.001*** |
| Solicited AR D7 | 499 (28.51) | 473 (27.03) | 373 (24.87) | 209 (20.90) | −4.484 | <0.001*** |
| Systemic AR D7 | 482 (27.54) | 459 (26.23) | 354 (23.60) | 196 (19.60) | −4.817 | <0.001*** |
| Fever | 335 (19.14) | 357 (20.40) | 279 (18.60) | 164 (16.40) | −1.836 | <0.001*** |
| Diarrhea | 105 (6.00) | 62 (3.54) | 46 (3.07) | 15 (1.50) | −6.084 | <0.001*** |
| ANV | 129 (1.37) | 84 (4.80) | 57 (3.80) | 35 (3.50) | −5.044 | <0.001*** |
| IDF | 99 (5.66) | 64 (3.66) | 39 (2.60) | 25 (2.50) | −4.866 | <0.001*** |
| Allergy | 19 (1.09) | 23 (1.31) | 14 (0.93) | 7 (0.70) | −1.120 | 0.263 |
| Local AR D7 | 38 (2.17) | 29 (1.66) | 35 (2.33) | 33 (3.30) | 1.941 | 0.052 |
| Pain | 12 (0.69) | 19 (1.09) | 21 (1.40) | 28 (2.80) | −4.425 | <0.001*** |
| Redness | 18 (1.03) | 3 (0.17) | 5 (0.33) | 6 (0.60) | −1.728 | 0.084 |
| Pruritus | 8 (0.48) | 7 (0.40) | 11 (0.73) | 4 (0.40) | 0.389 | 0.698 |
| Swelling | 12 (0.69) | 2 (0.11) | 2 (0.13) | 6 (0.60) | −0.890 | 0.373 |
| Induration | 2 (0.11) | 4 (0.23) | 2 (0.13) | 3 (0.30) | 0.795 | 0.427 |
| Unsolicited AR D28 | 25 (1.43) | 29 (1.66) | 11 (0.73) | 24 (2.40) | 0.810 | 0.418 |
| Cold/RTI | 25 (1.43) | 29 (1.66) | 11 (0.73) | 23 (2.30) | 0.642 | 0.521 |
N: the number of participants; n: the number of participants with adverse reaction.
RTI: respiratory tract infection; ANV: anorexia/nausea/vomiting; IDF: irritability/drowsiness/fatigue.
*
P < 0.05;
**
P < 0.01
***
P < 0.001.