Table 2.
Adverse events occurring from the first dose to 30 days (phase 1) or 42 days (phase 2 and extension trials) after the second dose
|
Vaccine group (n=684) |
Placebo group (n=400) |
|||||||
|---|---|---|---|---|---|---|---|---|
| Any | Grade 1 | Grade 2 | Grade 3 | Any | Grade 1 | Grade 2 | Grade 3 | |
| All adverse events | 166 (24%) | 113 (17%) | 44 (6%) | 9 (1%) | 109 (27%) | 73 (18%) | 34 (9%) | 2 (1%) |
| All adverse reactions | 133 (19%) | 112 (16%) | 17 (2%) | 4 (1%) | 86 (22%) | 75 (19%) | 10 (3%) | 1 (0%) |
| Any local reactions | 55 (8%) | 48 (7%) | 7 (1%) | 0 (0%) | 37 (9%) | 33 (8%) | 4 (1%) | 0 (0%) |
| Rhinorrhoea | 34 (5%) | 30 (4%) | 4 (1%) | 0 (0%) | 27 (7%) | 25 (6%) | 2 (1%) | 0 (0%) |
| Itchy nose | 13 (2%) | 13 (2%) | 0 (0%) | 0 (0%) | 6 (2%) | 6 (2%) | 0 (0%) | 0 (0%) |
| Nasal congestion | 10 (1%) | 9 (1%) | 1 (0%) | 0 (0%) | 15 (4%) | 14 (4%) | 1 (0%) | 0 (0%) |
| Pharyngalgia | 8 (1%) | 5 (1%) | 3 (0%) | 0 (0%) | 9 (2%) | 7 (2%) | 2 (1%) | 0 (0%) |
| Sneezing | 3 (0%) | 2 (0%) | 1 (0%) | 0 (0%) | 1 (0%) | 1 (0%) | 0 (0%) | 0 (0%) |
| Epistaxis | 1 (0%) | 1 (0%) | 0 (0%) | 0 (0%) | 2 (1%) | 2 (1%) | 0 (0%) | 0 (0%) |
| Rhinalgia | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (1%) | 3 (1%) | 0 (0%) | 0 (0%) |
| Oropharyngeal discomfort | 1 (0%) | 1 (0%) | 0 (0%) | 0 (0%) | 1 (0%) | 1 (0%) | 0 (0%) | 0 (0%) |
| Any systemic reactions | 103 (15%) | 84 (12%) | 15 (2%) | 4 (1%) | 69 (17%) | 59 (15%) | 9 (2%) | 1 (0%) |
| Fever | 42 (6%) | 38 (6%) | 1 (0%) | 3 (0%) | 30 (8%) | 28 (7%) | 1 (0%) | 1 (0%) |
| Headache | 19 (3%) | 16 (2%) | 3 (0%) | 0 (0%) | 20 (5%) | 19 (5%) | 1 (0%) | 0 (0%) |
| Cough | 19 (3%) | 15 (2%) | 4 (1%) | 0 (0%) | 15 (4%) | 11 (3%) | 4 (1%) | 0 (0%) |
| Fatigue | 20 (3%) | 19 (3%) | 1 (0%) | 0 (0%) | 17 (4%) | 15 (4%) | 2 (1%) | 0 (0%) |
| Dizziness | 11 (2%) | 11 (2%) | 0 (0%) | 0 (0%) | 8 (2%) | 7 (2%) | 1 (0%) | 0 (0%) |
| Nausea | 7 (1%) | 6 (1%) | 1 (0%) | 0 (0%) | 5 (1%) | 4 (1%) | 1 (0%) | 0 (0%) |
| Diarrhoea | 8 (1%) | 5 (1%) | 2 (0%) | 1 (0%) | 5 (1%) | 4 (1%) | 1 (0%) | 0 (0%) |
| Vomiting | 5 (1%) | 3 (0%) | 2 (0%) | 0 (0%) | 1 (0%) | 1 (0%) | 0 (0%) | 0 (0%) |
| Myalgia | 7 (1%) | 5 (1%) | 2 (0%) | 0 (0%) | 10 (3%) | 9 (2%) | 1 (0%) | 0 (0%) |
| Abdominal pain | 3 (0%) | 0 (0%) | 3 (0%) | 0 (0%) | 2 (1%) | 2 (1%) | 0 (0%) | 0 (0%) |
| Allergic reaction | 3 (0%) | 1 (0%) | 2 (0%) | 0 (0%) | 2 (1%) | 2 (1%) | 0 (0%) | 0 (0%) |
| Arthralgia | 1 (0%) | 0 (0%) | 1 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Upper respiratory tract infection | 1 (0%) | 0 (0%) | 1 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Leg aches | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (0%) | 1 (0%) | 0 (0%) | 0 (0%) |
| Anorexia | 1 (0%) | 1 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Pruritus | 1 (0%) | 0 (0%) | 1 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Chest discomfort | 1 (0%) | 1 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Palpitations | 1 (0%) | 1 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Blurred vision | 1 (0%) | 1 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Data are n (%), where n is the number of participants reporting an adverse event. All adverse events were graded according to the guidelines for grading standards of adverse events in clinical trials of preventive vaccines issued by China National Medical Products Administration.