Table 2.
Percentage of Participants Experiencing Solicited Local and General Symptoms in the MenACWY-TT and MenACWY-DT Groups During 4-Day Period After Vaccination (Total Vaccinated Cohort)
| Symptom | Type | MenACWY-TT lot A (N = 329) |
MenACWY-TT lot B (N = 329) |
MenACWY-DT (N = 325) |
|||
|---|---|---|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | ||
| Local | |||||||
| Pain | All | 169 | 51.4 (45.8, 56.9) | 167 | 50.8 (45.2, 56.3) | 180 | 55.4 (49.8, 60.9) |
| Grade 3 | 8 | 2.4 (1.1, 4.7) | 5 | 1.5 (0.5, 3.5) | 2 | 0.6 (0.1, 2.2) | |
| Redness (mm) | All | 85 | 25.8 (21.2, 30.9) | 60 | 18.2 (14.2, 22.8) | 66 | 20.3 (16.1, 25.1) |
| Grade 3 | 3 | 0.9 (0.2, 2.6) | 2 | 0.6 (0.1, 2.2) | 6 | 1.8 (0.7, 4.0) | |
| Swelling (mm) | All | 63 | 19.1 (15.0, 23.8) | 40 | 12.2 (8.8, 16.2) | 44 | 13.5 (10.0, 17.7) |
| Grade 3 | 3 | 0.9 (0.2, 2.6) | 3 | 0.9 (0.2, 2.6) | 3 | 0.9 (0.2, 2.7) | |
| General | |||||||
| Fatigue | All | 96 | 29.2 (24.3, 34.4) | 94 | 28.6 (23.8, 33.8) | 89 | 27.3 (22.5, 32.5) |
| Grade 3 | 9 | 2.7 (1.3, 5.1) | 7 | 2.1 (0.9, 4.3) | 5 | 1.5 (0.5, 3.5) | |
| Gastrointestinala | All | 43 | 13.1 (9.6, 17.2) | 43 | 13.1 (9.6, 17.2) | 44 | 13.5 (10.0, 17.7) |
| Grade 3 | 4 | 1.2 (0.3, 3.1) | 3 | 0.9 (0.2, 2.6) | 4 | 1.2 (0.3, 3.1) | |
| Headache | All | 86 | 26.1 (21.5, 31.2) | 87 | 26.4 (21.8, 31.6) | 83 | 25.5 (20.8, 30.6) |
| Grade 3 | 5 | 1.5 (0.5, 3.5) | 2 | 0.6 (0.1, 2.2) | 6 | 1.8 (0.7, 4.0) | |
| Fever | All | 17 | 5.2 (3.0, 8.1) | 14 | 4.3 (2.3, 7.0) | 16 | 4.9 (2.8, 7.8) |
| Grade 3b | 1 | 0.3 (0.0, 1.7) | 0 | 0 (0.0, 1.1) | 0 | 0 (0.0, 1.1) | |
Abbreviations: CI, confidence interval; N, total number of participants, with the documented dose; n/%, number/percentage of participants reporting the symptom at least once.
aGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
bTemperature >39.5°C.