Table 4.
Summary of Solicited and Unsolicited Adverse Events for the Overall Vaccination Period (Full Analysis Set).
|
Lot Group 1 (N = 377) n (%) [events] |
Lot Group 2 (N = 375) n (%) [events] |
Lot Group 3 (N = 377) n (%) [events] |
Overall (N = 1129) n (%) [events] |
|
|---|---|---|---|---|
| Unsolicited AEs | 88 (23.3) [1 4 3] | 110 (29.3) [1 7 2] | 98 (26.0) [1 6 2] | 296 (26.2) [4 7 7] |
| Relateda | 33 (8.8) [58] | 38 (10.1) [54] | 37 (9.8) [48] | 108 (9.6) [1 6 0] |
| Grade ≥ 3 | 6 (1.6) [7] | 8 (2.1) [10] | 7 (1.9) [10] | 21 (1.9) [27] |
| Grade ≥ 3 Related | 2 (0.5) [2] | 0 | 1 (0.3) [1] | 3 (0.3) [3] |
| Led to Withdrawal from Second Vaccination | 6 (1.6) [11] | 4 (1.1) [5] | 2 (0.5) [7] | 12 (1.1) [23] |
| Led to Trial Withdrawal | 0 | 0 | 0 | 0 |
| Fatal | 0 | 1 (0.3) [1] | 0 | 1 (0.1) [1] |
| Local Solicited AEsb | 338 (89.7) [1967] | 348 (92.8) [2082] | 344 (91.2) [2025] | 1030 (91.2) [6074] |
| Led to Vaccine Deferral | 1 (0.3) [1] | 0 | 1 (0.3) [1] | 2 (0.2) [2] |
| Led to Vaccine Discontinuation | 0 | 0 | 0 | 0 |
| General Solicited AEsc | 253 (67.1) [8 1 1] | 267 (71.2) [9 1 2] | 266 (70.6) [9 1 5] | 786 (69.6) [2638] |
| Relateda | 246 (65.3) [7 7 3] | 256 (68.3) [8 4 9] | 252 (66.8) [8 3 4] | 754 (66.8) [2456] |
| Led to Vaccine Deferral | 0 | 0 | 3 (0.8) [3] | 3 (0.3) [3] |
| Led to Vaccine Discontinuation | 0 | 0 | 0 | 0 |
| Serious Adverse Events | 1 (0.3) [1] | 3 (0.8) [3] | 1 (0.3) [1] | 5 (0.4) [5] |
| Relateda | 0 | 0 | 0 | 0 |
| Grade ≥ 3 | 0 | 2 (0.5) [2] | 1 (0.3) [1] | 3 (0.3) [3] |
|
Cardiac AEs of Special Interestd |
2 (0.5) [2] | 3 (0.8) [3] | 1 (0.3) [3] | 6 (0.5) [8] |
| Relateda | 0 | 1 (0.3) [1] | 0 | 1 (0.1) [1] |
| Grade ≥ 3 | 1 (0.3) [1] | 0 | 0 | 1 (0.1) [1] |
Abbreviations: AE = Adverse Event; ECG = Electrocardiogram; N = number of subjects in the specified group; n = number of subjects reporting an AE in the specified category.
Note: This summary includes all AEs, SAEs, AESIs, Grade ≥ 3 AEs, and fatalities reported during the overall vaccination period only. The overall vaccination period is the time from first vaccination through the second vaccination + 35 days or the date of the last visit, whichever is later. Adverse events are presented separately for the two vaccination periods and additionally for the follow-up period in the Supplemental Materials.
Related AEs were either considered at least possibly related to trial vaccine by the investigator or had missing information pertaining to relatedness.
Local solicited AEs included redness, swelling, induration, pruritus, and pain within 8 days after each vaccination. All local solicited AEs were considered related to trial vaccine, as defined in the protocol.
General solicited AEs included pyrexia, headache, myalgia, chills, nausea, and fatigue within 8 days after each vaccination. General solicited AEs were considered related when the investigator considered them at least possibly related to vaccination or when information on relatedness was missing.
Cardiac AEs of special interest were defined as any cardiac sign or symptom that developed after the first vaccination, including ECG changes determined to be clinically significant and cardiac enzyme troponin I levels above the upper limit of normal. These were the only AEs of special interest defined in this trial.