Table 3.
Adverse reactions within 28 days after the third dose
|
Cohort 1a-14d-2m |
Cohort 1b-14d-8m |
Cohort 2a-28d-2m |
Cohort 2b-28d-8m |
Cohort 3–28d-8m |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 μg (N=55) | 6 μg (n=58) | Placebo (N=26) | 3 μg (N=55) | 6 μg (N=56) | Placebo (N=30) | 3 μg (N=54) | 6 μg (N=50) | Placebo (N=26) | 3 μg (N=52) | 6 μg (N=50) | Placebo (N=28) | 1·5 μg (N=85) | 3 μg (N=90) | 6 μg (N=81) | Placebo (N=47) | |
| Any adverse reaction | ||||||||||||||||
| Grade 1 | 5 (9%) | 5 (9%) | 0 | 10 (18%) | 13 (23%) | 3 (10%) | 3 (6%) | 1 (2%) | 0 | 7 (13%) | 10 (20%) | 1 (4%) | 3 (4%) | 3 (3%) | 3 (4%) | 2 (4%) |
| Grade 2 | 1 (2%) | 1 (2%) | 0 | 1 (2%) | 0 | 1 (3%) | 0 | 0 | 0 | 1 (2%) | 1 (2%) | 1 (4%) | 1 (1%) | 2 (2%) | 2 (2%) | 1 (2%) |
| Systemic diseases and injection site adverse reactions | ||||||||||||||||
| Injection site pain | 3 (5%) | 5 (9%) | 0 | 8 (1%) | 9 (16%) | 0 | 1 (2%) | 1 (2%) | 0 | 6 (12%) | 7 (14%) | 0 | 1 (1%) | 2 (2%) | 2 (2%) | 1 (2%) |
| Injection site swelling | 0 | 0 | 0 | 0 | 0 | 1 (3%) | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Injection site itch | 0 | 0 | 0 | 0 | 1 (2%) | 2 (7%) | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Injection site erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 | 0 |
| Fever | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 1 (2%) | 1 (2%) | 1 (4%) | 0 | 0 | 0 | 0 |
| Fatigue | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 1 (2%) | 0 | 0 | 1 (2%) | 2 (4%) | 0 | 0 | 1 (1%) | 0 | 1 (2%) |
| Respiratory, thoracic, and mediastinal disorders | ||||||||||||||||
| Cough | 0 | 1 (2%) | 0 | 0 | 2 (4%) | 0 | 2 (4%) | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 | 1 (1%) | 1 (2%) |
| Runny nose | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 1 (1%) | 0 |
| Oropharyngeal pain | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Laryngeal stimulation | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nervous system disorders | ||||||||||||||||
| Dizziness | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 1 (1%) | 0 | 0 |
| Headache | 0 | 1 (2%) | 0 | 1 (2%) | 2 (4%) | 1 (3%) | 0 | 0 | 0 | 1 (2%) | 1 (2%) | 1 (4%) | 0 | 0 | 1 (1%) | 0 (0%) |
| Gastrointestinal disorders | ||||||||||||||||
| Diarrhoea | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea | 1 (2%) | 1 (2%) | 0 | 1 (2%) | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 2 (4%) | 0 | 1 (1%) | 1 (1%) | 0 | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Muscle pain | 1 (2%) | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myalgia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 1 (1%) | 0 | 0 | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Rash | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
| Eye disorders | ||||||||||||||||
| Periorbital oedema | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Data are n (%), representing the total number of participants who had adverse reactions (ie, adverse events related to vaccination).