Table 3 Adverse reactions within 28 days after the third dose
1.5 μg group (n = 173) | 3.0 μg group (n = 173) | Total (n = 346) | |
---|---|---|---|
Any adverse reaction | |||
Total | 14 (8.1) | 15 (8.7) | 29 (8.4) |
Grade 1 (mild) | 9 (5.2) | 11 (6.4) | 20 (5.8) |
Grade 2 (moderate) | 5 (2.9) | 4 (2.3) | 9 (2.6) |
Systemic diseases and injection site adverse reactions | |||
Injection site pain | 5 (2.9) | 9 (5.2) | 14 (4.1) |
Fever | 3 (1.7) | 2 (1.2) | 5 (1.5) |
Injection site itch | 3 (1.7) | 1 (0.6) | 4 (1.2) |
Injection site swelling | 0 | 1 (0.6) | 1 (0.3) |
Fatigue | 0 | 1 (0.6) | 1 (0.3) |
Respiratory, thoracic, and mediastinal disorders | |||
Cough | 4 (2.3) | 1 (0.6) | 5 (1.5) |
Runny nose | 0 | 1 (0.6) | 1 (0.3) |
Skin and subcutaneous tissue disorders | |||
Itch | 1 (0.6) | 1 (0.6) | 2 (0.6) |
Erythema | 1 (0.6) | 0 | 1 (0.3) |
Rash | 0 | 1 (0.6) | 1 (0.3) |
Gastrointestinal disorders | |||
Nausea | 1 (0.6) | 0 | 1 (0.3) |
Abdominal pain | 0 | 1 (0.6) | 1 (0.3) |