Table 2.
Summary of Solicited and Unsolicited AEs Within 28 Days of Any Injection and Other AEs of Interest in the Full Analysis Set
| Adverse Events | Clade C (n = 26) | Bivalent (n = 100) | Placebo (n = 26) |
|---|---|---|---|
| Any solicited AEs | 25 (96) | 96 (96) | 22 (85) |
| Solicited local AEs | 24 (92) | 94 (94) | 17 (65) |
| ȃGrade 3 pain/tenderness | 3 (12) | 2 (2) | 0 |
| Solicited systemic AEs | 22 (85) | 90 (90) | 19 (73) |
| ȃGrade 3 solicited systemic AEs | 5 (19) | 15 (15) | 0 |
| ȃFatigue | 19 (73) | 78 (78) | 18 (69) |
| ȃHeadache | 15 (58) | 69 (69) | 16 (62) |
| ȃMyalgia | 15 (58) | 68 (68) | 9 (35) |
| Any unsolicited AEs | 13 (50) | 79 (79) | 21 (81) |
| ȃGrade 3 | 0 | 1 (1)a | 0 |
| ȃGrade 4 | 0 | 0 | 0 |
| Unsolicited AEs related to study injection | 0 | 9 (9) | 1 (4) |
| ȃGrade 3 or 4 | 0 | 0 | 0 |
| ȃGastrointestinal disorders, vomiting | 0 | 4 (4) | 0 |
| ȃNervous system disorders, postural dizziness | 0 | 2 (2) | 0 |
| ȃRespiratory, thoracic, and mediastinal disorders | 0 | 2 (2) | 0 |
| ȃEczema | 0 | 0 | 1 (4) |
| AEs leading to discontinuation of study vaccine | 1 (4) | 1 (1) | 0 |
| ȃRelated to vaccine | 0 | 0 | 0 |
| ȃCeliac disease | 0 | 1 (1) | 0 |
| ȃMuscular weakness for 7 days | 1 (4) | 0 | 0 |
| Grade 3 laboratory abnormalities | 0 | 1 (1)b | 0 |
| Grade 3 vital sign abnormalities | 1 (4) | 2 (2) | 1 (4) |
| ȃBradycardia | 1 (4) | 0 | 1 (4) |
| ȃTachycardia | 0 | 2 (2) | 0 |
| ȃConsidered as AEs | 0 | 0 | 0 |
| Serious AEs | 0 | 0 | 0 |
| HIV infection during the study | 0 | 0 | 0 |
| Death | 0 | 0 | 0 |
Data are No. (%).
Abbreviations: AE, adverse event; HIV, human immunodeficiency virus.
Blood creatinine increased.
Absolute neutrophil count decreased.