Proportion (%) of participants with solicited local and general adverse events (AEs) reported within the 7-day postvaccination period (Reactogenicity cohort N=682)
| Children (≤17 years) | Adults (>17 years) | |||||
|---|---|---|---|---|---|---|
| ImmunoComp | At-risk | Healthy | Immunocomp | At-risk | Healthy | |
| N=0 | N=76 | N=41 | N=37 | N=424 | N=70 | |
| Pain | 82.9 (72.5 to 90.6) | 73.2 (57.1 to 85.8) | 73.0 (55.9 to 86.2) | 78.5 (74.3 to 82.4) | 80.0 (68.7 to 88.6) | |
| Grade 3 | 10.5 (4.7 to 19.7) | 2.4 (0.1 to 12.9) | 2.7 (0.1 to 14.2) | 3.1 (1.6 to 5.2) | 5.7 (1.6 to 14.0) | |
| Redness | 53.9 (42.1 to 65.5) | 41.5 (26.3 to 57.9) | 27.0 (13.8 to 44.1) | 20.5 (16.8 to 24.7) | 11.4 (5.1 to 21.3) | |
| Grade 3 | 11.8 (5.6 to 21.3) | 0 (0 to 8.6) | 10.8 (3.0 to 25.4) | 1.7 (0.7 to 3.4) | 0 (0 to 5.1) | |
| Swelling | 43.4 (32.1 to 55.3) | 19.5 (8.8 to 34.9) | 21.6 (9.8 to 38.2) | 16.7 (13.3 to 20.6) | 17.1 (9.2 to 28.0) | |
| Grade 3 | 9.2 (3.8 to 18.1) | 0 (0 to 8.6) | 5.4 (0.7 to 18.2) | 0.5 (0.1 to 1.7) | 4.3 (0.9 to 12.0) | |
| Children (<5 years) | Children (5–17 years) | Adults (>17 years) | |||||
|---|---|---|---|---|---|---|---|
| At-risk | Healthy | At-risk | Healthy | Immunocomp | At-risk | Healthy | |
| All general (N) | 28 | 27 | 49 | 14 | 38 | 431 | 70 |
| Drowsiness | 28.6 (13.2 to 48.7) | 48.1 (28.7 to 68.1) | |||||
| Grade 3 | 3.6 (0.1 to 18.3) | 7.4 (0.9 to 24.3) | |||||
| Irritability | 57.1 (37.2 to 75.5) | 66.7 (46.0 to 83.5) | |||||
| Grade 3 | 7.1 (0.9 to 23.5) | 7.4 (0.9 to 24.3) | |||||
| Loss of appetite | 39.3 (21.5 to 59.4) | 37.0 (19.4 to 57.6) | |||||
| Grade 3 | 3.6 (0.1 to 18.3) | 7.4 (0.9 to 24.3) | |||||
| Fever | 10.7 (2.3 to 28.2) | 22.2 (8.6 to 42.3) | 14.3 (5.9 to 27.2) | 28.6 (8.4 to 58.1) | 5.3 (0.6 to 17.7) | 2.1 (1.0 to 3.9) | 4.3 (0.9 to 12.0) |
| Grade 3 | 0 (0 to 12.3) | 3.7 (0.1 to 19.0) | 2.0 (1.0 to 10.9) | 0 (0 to 23.2) | 0 (0 to 9.3) | 0.5 (0.1 to 1.7) | 0 (0 to 5.1) |
| Fatigue | 46.9 (32.5 to 61.7) | 35.7 (12.8 to 64.9) | 55.3 (38.3 to 71.4) | 32.7 (28.3 to 37.4) | 40.0 (28.5 to 52.4) | ||
| Grade 3 | 4.1 (0.5 to 14.0) | 0 (0 to 23.2) | 7.9 (1.7 to 21.4) | 1.9 (0.8 to 3.6) | 7.1 (2.4 to 15.9) | ||
| Gastrointestinal | 24.5 (13.3 to 38.9) | 21.4 (4.7 to 50.8) | 31.6 (17.5 to 48.7) | 15.8 (12.5 to 19.6) | 20.0 (11.4 to 31.3) | ||
| Grade 3 | 4.1 (0.5 to 14.0) | 0 (0 to 23.2) | 2.6 (0.1 to 13.8) | 1.4 (0.5 to 3.0) | 5.7 (1.6 to 14.0) | ||
| Headache | 44.9 (30.7 to 59.8) | 28.6 (8.4 to 58.1) | 39.5 (24.0 to 56.6) | 34.3 (29.9 to 39.0) | 41.4 (29.8 to 53.8) | ||
| Grade 3 | 6.1 (1.3 to 16.9) | 0 (0 to 23.2) | 5.3 (0.6 to 17.7) | 1.2 (0.4 to 2.7) | 5.7 (1.6 to 14.0) | ||
| Joint pain | 28.6 (16.6 to 43.3) | 28.6 (8.4 to 58.1) | 44.7 (28.6 to 61.7) | 26.0 (21.9 to 30.4) | 28.6 (18.4 to 40.6) | ||
| Grade 3 | 4.1 (0.5 to 14.0) | 0 (0 to 23.2) | 0 (0 to 9.3) | 1.9 (0.8 to 3.6) | 5.7 (1.6 to 14.0) | ||
| Muscle aches | 65.3 (50.4 to 78.3) | 50.0 (23.0 to 77.0) | 65.8 (48.6 to 80.4) | 43.9 (39.1 to 48.7) | 55.7 (43.3 to 67.6) | ||
| Grade 3 | 6.1 (1.3 to 16.9) | 0 (0 to 23.2) | 7.9 (1.7 to 21.4) | 2.1 (1.0 to 3.9) | 5.7 (1.6 to 14.0) | ||
| Shivering | 28.6 (16.6 to 43.3) | 14.3 (1.8 to 42.8) | 36.8 (21.8 to 54.0) | 15.3 (12.0 to 19.1) | 17.1 (9.2 to 28.0) | ||
| Grade 3 | 4.1 (0.5 to 14.0) | 0 (0 to 23.2) | 2.6 (0.1 to 13.8) | 1.6 (0.7 to 3.3) | 2.9 (0.3 to 9.9) | ||
| Sweating | 20.4 (10.2 to 34.3) | 7.1 (0.2 to 33.9) | 21.1 (9.6 to 37.3) | 11.4 (8.5 to 14.8) | 15.7 (8.1 to 26.4) | ||
| Grade 3 | 0 (0 to 7.3) | 0 (0 to 23.2) | 0 (0 to 9.3) | 1.4 (0.5 to 3.0) | 1.4 (0 to 7.7) | ||
Fever was defined as an oral or axillary temperature of ≥37.5°C (99.5°F) or a rectal temperature of ≥38.0°C (100.4°F).
Grade 3 redness was defined as being >50 mm, grade 3 swelling was > 50 mm and grade 3 fever was >39°C
%(95% CI), percentage of participants reporting the event with exact 95% confidence limit (lower limit–upper limit); N, number of participants in the cohort.