Table 2.
Adverse events (AE) possibly, probably, or definitely related to vaccine, through Day 28 post-vaccination.
|
Adverse Event (AE) Severity |
Treatment Arm |
P-value1 | |
|---|---|---|---|
|
fIPV (N = 10) n (%) |
fIPV + dmLT (N = 19) n (%) |
||
| Systemic AEs | |||
| Fatigue | 1 (10.0) | 4 (21.1) | 0.424 |
| Headache | 1 (10.0) | 3 (15.8) | 0.571 |
| Anorexia | 0 | 2 (10.5) | 0.421 |
| Myalgia | 1 (10.0) | 1 (5.3) | 0.889 |
| mild | 1 | 0 | |
| moderate | 0 | 1 | |
| Arthralgia | 1 (10.0) | 1 (5.3) | 0.889 |
| mild | 1 | 0 | |
| moderate | 0 | 1 | |
| Fever | 0 | 1 (5.3) | 0.655 |
| Diarrhea | 0 | 1 (5.3) | 0.655 |
| Nausea | 0 | 0 | N/A |
| Vomiting | 0 | 0 | N/A |
| Rash | 0 | 0 | N/A |
| Local reactogenicity AEs | |||
| Erythema | 10 (100.0) | 17 (89.4) | 1.000 |
| Tenderness | 7 (70.0) | 16 (84.2) | 0.330 |
| Induration | 5 (50.0) | 18 (94.7) | 0.010 |
| Hyperpigmentation2 | 2 (20.0) | 14 (73.7) | 0.008 |
| Pruritus | 0 | 8 (42.1) | 0.017 |
| Pain | 1 (10.0) | 2 (10.5) | 0.733 |
| Rash at Injection site | 0 | 1 (5.3) | 0.655 |
| Hypopigmentation | 0 | 0 | N/A |
| Edema | 0 | 0 | N/A |
| Unsolicited AEs | |||
| Upper arm muscle pain | 2 (20.0) | 0 | 1.000 |
| Shoulder joint pain | 0 | 1 (5.3) | 0.655 |
| Bruising at injection site | 1 (10.0) | 1 (5.3) | 0.889 |
| Desquamation | 0 | 2 (10.5) | 0.421 |
All AEs were mild, except where noted.
1
One-sided P-value Fisher’s Exact test for increased incidence in fIPV + dmLT arm.
2
One additional instance of hyperpigmentation with onset at study Day 36 in the fIPV + dmLT group is not included in the table.