Table 5.
Adverse reactions within 30 days after whole vaccination procedure for group aged 13–17 years
|
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 | 10 (11·90%) | 4 (14·29%) | 0·74 | 13 (15·48%) | 0 | 0·027 | 6 (7·14%) | 1 (3·57%) | 0·50 | 29 (24·52%) | 5 (5·96%) | 0·14 | |
| Grade 1 | 9 (10·71%) | 4 (14·29%) | .. | 13 (15·48%) | 0 | .. | 6 (7·14%) | 1 (3·57%) | .. | 28 (11·11%) | 5 (5·96%) | .. | |
| Grade 2 | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
| Pain | 5 (5·95%) | 1 (3·57%) | 0·63 | 12 (14·29%) | 0 | 0·034 | 3 (3·57%) | 0 | 0·31 | 20 (7·94%) | 0 | 0·0078 | |
| Grade 1 | 5 (5·95%) | 1 (3·57%) | .. | 12 (14·29%) | 0 | .. | 3 (3·57%) | 0 | .. | 20 (7·94%) | 0 | .. | |
| Redness | 4 (4·76%) | 2 (7·14%) | 0·63 | 0 | 0 | 1 | 3 (3·57%) | 1 (3·57%) | 1 | 7 (2·78%) | 3 (3·57%) | 0·72 | |
| Grade 1 | 3 (3·57%) | 2 (7·14%) | .. | 0 | 0 | .. | 3 (3·57%) | 1 (3·57%) | .. | 6 (2·38%) | 3 (3·57%) | .. | |
| Grade 2 | 1 (1·19 %) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
| Itches | 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 | 0 | 1 (3·57%) | 0·082 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 (1·19%) | 0·41 | |
| Grade 1 | 0 | 1 (3·57%) | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 1 (1·19%) | .. | |
| Systemic adverse reactions whole vaccination procedure dose | |||||||||||||
| Any | 28 (33·33%) | 0 | 0·0004 | 17 (20·24%) | 1 (3·57%) | 0·038 | 12 (14·29%) | 9 (10·71%) | 0·036 | 57 (22·62%) | 10 (11·90%) | 0·033 | |
| Grade 1 | 24 (28·57%) | 0 | .. | 17 (20·24%) | 1 (3·57%) | .. | 9 (10·71%) | 8 (28·57%) | .. | 50 (19·84%) | 9 (10·71%) | .. | |
| Grade 2 | 4 (4·76%) | 0 | .. | 0 | 0 | .. | 3 (3·57%) | 1 (3·57%) | .. | 7 (2·78%) | 1 (1·19%) | .. | |
| Fever | 11 (13·10%) | 0 | 0·044 | 9 (10·71%) | 1 (3·57%) | 0·25 | 6 (7·14%) | 7 (0·25%) | 0·011 | 26 (10·32%) | 8 (9·52%) | 0·83 | |
| Grade 1 | 9 (10·71%) | 0 | .. | 9 (10·71%) | 1 (3·57%) | .. | 5 (5·95%) | 7 (0·25%) | .. | 23 (9·13%) | 8 (9·52%) | .. | |
| Grade 2 | 2 (2·38%) | 0 | .. | 0 | 0 | .. | 1 (1·19%) | 0 | .. | 3 (1·20%) | 0 | .. | |
| Fatigue | 4 (4·76%) | 0 | 0·24 | 0 | 0 | 1 | 0 | 0 | 1 | 4 (1·59%) | 0 | 0·24 | |
| Grade 1 | 3 (3·57%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 3 (1·20%) | 0 | .. | |
| Grade 2 | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (0·40%) | 0 | .. | |
| Nausea | 2 (2·18%) | 0 | 0·41 | 0 | 0 | 1 | 2 (2·18%) | 0 | 0·41 | 4 (1·59%) | 0 | 0·24 | |
| Grade 1 | 2 (2·18%) | 0 | .. | 0 | 0 | .. | 1 (1·19%) | 0 | .. | 3 (1·20%) | 0 | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 1 (1·19%) | 0 | .. | 1 (0·40%) | 0 | .. | |
| Cough | 1 (1·19%) | 0 | 0·56 | 3 (3·57%) | 0 | 0·31 | 2 (2·18%) | 1 (3·57%) | 0·79 | 6 (2·38%) | 1 (1·19%) | 0·51 | |
| Grade 1 | 0 | 0 | .. | 3 (3·57%) | 0 | .. | 1 (1·19%) | 1 (3·57%) | .. | 4 (1·59%) | 1 (1·19%) | .. | |
| Grade 2 | 1 (1·19%) | 0 | .. | 0 | 0 | .. | 1 (1·19%) | 0 | .. | 2 (0·79%) | 0 | .. | |
| Dyspnoea | 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 | .. | ||
| Muscle pain | 4 (4·76%) | 0 | 0·24 | 0 | 0 | 1 | 0 | 0 | 1 | 4 (1·59%) | 0 | 0·41 | |
| Grade 1 | 4 (4·76%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 4 (1·59%) | 0 | .. | |
| Vomiting | 2 (2·18%) | 0 | 0·41 | 0 | 0 | 1 | 2 (2·18%) | 0 | 0·41 | 4 (1·59%) | 0 | 0·41 | |
| Grade 1 | 2 (2·18%) | 0 | .. | 0 | 0 | .. | 2 (2·18%) | 0 | .. | 4 (1·59%) | 0 | .. | |
| Headache | 2 (2·18%) | 0 | 0·41 | 1 (1·19%) | 0 | 0·56 | 0 | 1 (3·57%) | 0·082 | 3 (1·20%) | 0 | 0·31 | |
| Grade 1 | 2 (2·18%) | 0 | .. | 1 (1·19%) | 0 | .. | 0 | 1 (3·57%) | .. | 3 (1·20%) | 1 (1·19%) | .. | |
| Dysphagia | 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 | ||
| Diarrhoea | 0 | 0 | 1 | 4 (4·76%) | 0 | 0·24 | 0 | 1 (3·57%) | 0·082 | 4 (1·59%) | 1 (1·19%) | 0·79 | |
| Grade 1 | 0 | 0 | .. | 4 (4·76%) | 0 | .. | 0 | 0 | .. | 4 (1·59%) | 0 | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 1 (3·57%) | .. | 0 | 1 (1·19%) | .. | |
| Overall adverse reactions after whole vaccination procedure | |||||||||||||
| Any | 38 (45·24%) | 4 (14·29%) | 0·0034 | 30 (3·57%) | 1 (3·57%) | 0·0010 | 18 (21·43%) | 10 (35·71%) | 0·13 | 86 (34·13%) | 15 (17·86%) | 0·0049 | |
| Grade 1 | 33 (39·29%) | 4 (14·29%) | .. | 30 (3·57%) | 1 (3·57%) | .. | 15 (17·86%) | 9 (32·14%) | .. | 78 (30·95%) | 14 (16·67%) | .. | |
| Grade 2 | 5 (5·95%) | 0 | .. | 0 | 0 | .. | 3 (3·57%) | 1 (3·57%) | .. | 8 (3·17%) | 1 (1·19%) | .. | |
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.