Table 4. Summary of adverse events by system organ class and preferred term with route of delivery and relationship to investigational product*.
| Total AEs by grade | ||||||
|---|---|---|---|---|---|---|
| System organ
class (Preferred term) |
Route of delivery | 1 | 2 | 3 | 4 | Relationship to study |
| General disorders and administration site conditions | 3 | - | - | - | ||
| Injection site burning | IM | 1 | - | - | - | Definitely |
| Injection site anesthesia | IM | 1 | - | - | - | Probable |
| Injection site warmth | IM | 1 | - | - | - | Probable |
| Injury, poisoning and procedural complications | 1 | - | - | |||
| Injection site hematoma | IM | 1 | - | - | - | Probable |
| Investigations | 1 | - | - | - | ||
| Blood creatine increased‡ | IM | 1 | - | - | - | Probable |
| Nervous system disorders | 3 | 1 | - | - | ||
| Hypoaesthesia | IM | 1 | - | - | - | Possible |
| Paraesthesia | IM | - | 1 | - | - | Possible |
| Headache | ID | 1 | - | - | - | Not related |
| Muscle contractions involuntary | ID | 1 | - | - | - | Possibly |
| Gastrointestinal disorders | 1 | - | - | - | ||
| Abdominal pain | ID | 1 | - | - | - | Not related |
| Diarrhea | ID | 1 | - | - | - | Not related |
| Nausea/Vomiting | ID | 1 | - | - | - | Not related |
| Musculoskeletal and connective tissue disorders | 1 | - | - | - | ||
| Myalgia | ID | 1 | - | - | - | Not related |
| Respiratory, thoracic, and mediastinal disorders | 2 | 1 | - | - | ||
| Cough | ID | 1 | - | - | - | Not related |
| Rhinorrhoea | ID | 1 | - | - | - | Not related |
| Nasal congestion | ID | 1 | - | - | - | Not related |
| Wheezing | ID | - | 1 | - | - | Not related |
Note: *In accordance with FDA toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. ‡Normal range for females: 24 – 174 U/L, for males: 24 – 204 U/L