Table 4.
Adverse reactions within 30 days after whole vaccination procedure for group aged 6–12 years in phase 1/2
|
2 μg cohort (n=112) |
4 μg cohort (n=112) |
8 μg cohort (n=112) |
Total (n=336) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vaccination (n=84) | Control (n=28) | p value | Vaccination (n=84) | Control (n=28) | p value | Vaccination (n=84) | Control (n=28) | p value | Vaccination (n=252) | Control (n=84) | p value | ||
| Injection site adverse reactions after whole vaccination procedure dose | |||||||||||||
| Any | 8 (9·52%) | 1 (3·57%) | 0·32 | 19 (22·62%) | 0 | 0·0057 | 11 (13·10%) | 0 | 0·044 | 38 (15·08%) | 1 (1·19%) | 0·0006 | |
| Grade 1 | 6 (7·14%) | 1 (3·57%) | .. | 18 (21·43%) | 0 | .. | 10 (11·90%) | 0 | .. | 34 (13·49%) | 1 (1·19%) | .. | |
| Grade 2 | 2 (2·38%) | 0 | .. | 1 (1·19%) | 0 | .. | 1 (1·19%) | 0 | .. | 4 (1·59%) | 0 | .. | |
| Pain | 5 (5·95%) | 1 (3·57%) | 0·63 | 10 (11·90%) | 0 | 0·056 | 8 (9·52%) | 0 | 0·090 | 23 (9·13%) | 1 (1·19%) | 0·014 | |
| Grade 1 | 5 (5·95%) | 1 (3·57%) | .. | 10 (11·90%) | 0 | .. | 8 (9·52%) | 0 | .. | 23 (9·13%) | 1 (1·19%) | .. | |
| Redness | 1 (1·19%) | 0 | 0·56 | 6 (7·14%) | 0 | 0·15 | 3 (3·57%) | 0 | 0·31 | 10 (3·97%) | 0 | 0·056 | |
| Grade 1 | 0 | 0 | .. | 5 (5·95%) | 0 | .. | 2 (2·38%) | 0 | .. | 7 (2·78%) | 0 | .. | |
| Grade 2 | 1 (1·19%) | 0 | .. | 1 (1·19%) | 0 | .. | 1 (1·19%) | 0 | .. | 3 (1·19%) | 0 | .. | |
| Itching | 1 (1·19%) | 0 | 0·56 | 1 (1·19%) | 0 | 0·56 | 0 | 0 | 1 | 2 (0·79%) | 0 | 0·41 | |
| Grade 1 | 1 (1·19%) | 0 | .. | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 2 (0·79%) | 0 | .. | |
| Swelling | 1 (1·19%) | 0 | 0·56 | 1 (1·19%) | 0 | 0·56 | 0 | 0 | 1 | 2 (0·79%) | 0 | 0·41 | |
| Grade 1 | 0 | 0 | .. | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
| Grade 2 | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
| Induration | 0 | 0 | 1 | 1 (1·19%) | 0 | 0·56 | 0 | 0 | 1 | 1 (0·40%) | 0 | 0·56 | |
| Grade 1 | 0 | 0 | .. | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
| Systemic adverse reactions whole vaccination procedure dose | |||||||||||||
| Any | 6 (7·14%) | 3 (10·71%) | 0·55 | 6 (7·14%) | 1 (3·57%) | 0·50 | 14 (16·67%) | 0 | 0·021 | 26 (10·32%) | 4 (4·76%) | 0·12 | |
| Grade 1 | 2 (2·38%) | 2 (7·14%) | .. | 4 (4·76%) | 0 | .. | 8 (9·52%) | 0 | .. | 14 (5·56%) | 2 (2·38%) | .. | |
| Grade 2 | 3 (3·57%) | 1 (3·57%) | .. | 2 (2·38%) | 1 (3·57%) | .. | 6 (7·14%) | 0 | .. | 11 (4·37%) | 2 (2·38%) | .. | |
| Grade 3 | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
| Fever | 2 (2·38%) | 0 | 0·41 | 1 (1·19%) | 1 (3·57%) | 0·44 | 10 (11·90%) | 0 | 0·056 | 13 (5·16%) | 1 (1·19%) | 0·12 | |
| Grade 1 | 0 | 0 | .. | 1 (1·19%) | 0 | .. | 5 (5·95%) | 0 | .. | 6 (2·38%) | 0 | .. | |
| Grade 2 | 2 (2·38%) | 0 | .. | 0 | 1 (3·57%) | .. | 5 (5·95%) | 0 | .. | 7 (2·78%) | 1 (1·19%) | .. | |
| Diarrhoea | 1 (1·19%) | 0 | 0·56 | 0 | 0 | 1 | 0 | 0 | 1 | 1 (0·40%) | 0 | 0·56 | |
| Grade 1 | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
| Constipation | 0 | 0 | 1 | 1 (1·19%) | 0 | 0·56 | 0 | 0 | 1 | 1 (0·40%) | 0 | 0·56 | |
| Grade 1 | 0 | 0 | .. | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
| Vomiting | 0 | 1 (3·57%) | 0·082 | 0 | 0 | 1 | 2 (2·38%) | 0 | 0·41 | 2 (0·79%) | 1 (1·19%) | >0·99 | |
| Grade 1 | 0 | 1 (3·57%) | .. | 0 | 0 | .. | 1 (1·19%) | 0 | .. | 1 (0·40%) | 1 (1·19%) | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 1 (1·19%) | 0 | .. | 1 (0·40%) | 0 | .. | |
| Cough | 2 (2·38%) | 1 (3·57%) | 0·74 | 4 (4·76%) | 0 | 0·24 | 2 (2·38%) | 0 | 0·41 | 8 (3·17%) | 1 (1·19%) | 0·46 | |
| Grade 1 | 1 (1·19%) | 1 (3·57%) | .. | 2 (2·38%) | 0 | .. | 2 (2·38%) | 0 | .. | 5 (1·98%) | 1 (1·19%) | .. | |
| Grade 2 | 1 (1·19%) | 0 | .. | 2 (2·38%) | 0 | .. | 0 | 0 | .. | 3 (1·19%) | 0 | .. | |
| Headache | 0 | 1 (3·57%) | 0·082 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 (1·19%) | 0·083 | |
| Grade 2 | 0 | 1 (3·57%) | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 1 (1·19%) | .. | |
| Acute allergic reaction | 1 (1·19%) | 0 | 0·56 | 0 | 0 | 1 | 0 | 0 | 1 | 1 (0·40%) | 0 | 0·56 | |
| Grade 3 | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
| Overall adverse reactions after whole vaccination procedure | |||||||||||||
| Any | 15 (17·86%) | 4 (14·28%) | 0·66 | 25 (29·76%) | 1 (3·57%) | 0·0045 | 25 (29·76%) | 0 | 0·0011 | 65 (25·79%) | 5 (5·95%) | 0·0001 | |
| Grade 1 | 9 (10·71%) | 3 (10·71%) | .. | 22 (26·19%) | 0 | .. | 18 (21·43%) | 0 | .. | 49 (19·44%) | 3 (3·57%) | .. | |
| Grade 2 | 5 (5·95%) | 1 (3·57%) | .. | 3 (3·57%) | 1 (3·57%) | .. | 7 (8·33%) | 0 | .. | 15 (5·95%) | 2 (2·38%) | .. | |
| Grade 3 | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
Data are n (%). Any refers to all the participants with any grade adverse reactions or reactions. Adverse reactions and reactions were graded according to the scale issued by the China State Food and Drug Administration. Grade 1 is mild, grade 2 is moderate, and grade 3 is severe.