Table 3.
Selected local injection site and systemic clinical reactions starting within 7 days of the second vaccine by age at enrolment for participants who received 1.0 μg followed by 10.0 μg (expanded safety cohort).
| 18–39 N = 81 | 40–59 N = 58 | 60–75 N = 77 | Total N = 216 | p-value | |
|---|---|---|---|---|---|
| Pain | 0.0022 | ||||
| Normal | 15 (18.5%) | 21 (36.2%) | 32 (41.6%) | 68 (31.5%) | |
| Grade 1 | 44 (54.3%) | 27 (46.6%) | 36 (46.8%) | 107 (49.5%) | |
| Grade 2 | 22 (27.2%) | 9 (15.5%) | 9 (11.7%) | 40 (18.5%) | |
| Grade 3 | 0 (0.0%) | 1 (1.7%) | 0 (0.0%) | 1 (0.5%) | |
| Tenderness/discomfort | 0.006 | ||||
| Normal | 4 (4.9%) | 8 (13.8%) | 10 (13.0%) | 22 (10.2%) | |
| Grade 1 | 41 (50.6%) | 39 (67.2%) | 49 (63.6%) | 129 (59.7%) | |
| Grade 2 | 35 (43.2%) | 11 (19.0%) | 18 (23.4%) | 64 (29.6%) | |
| Grade 3 | 1 (1.2%) | 0 (0.0%) | 0 (0.0%) | 1 (0.5%) | |
| Chills/shivering | 0.0002 | ||||
| Normal | 18 (22.2%) | 28 (48.3%) | 40 (51.9%) | 86 (39.8%) | |
| Grade 1 | 22 (27.2%) | 15 (25.9%) | 14 (18.2%) | 51 (23.6%) | |
| Grade 2 | 38 (46.9%) | 12 (20.7%) | 23 (29.9%) | 73 (33.8%) | |
| Grade 3 | 3 (3.7%) | 3 (5.2%) | 0 (0.0%) | 6 (2.8%) | |
| Myalgia (flu-like general muscle aches) | <0.0001 | ||||
| Normal | 16 (19.8%) | 26 (44.8%) | 39 (50.6%) | 81 (37.5%) | |
| Grade 1 | 25 (30.9%) | 16 (27.6%) | 23 (29.9%) | 64 (29.6%) | |
| Grade 2 | 37 (45.7%) | 13 (22.4%) | 15 (19.5%) | 65 (30.1%) | |
| Grade 3 | 3 (3.7%) | 3 (5.2%) | 0 (0.0%) | 6 (2.8%) | |
| Arthralgia | 0.09 | ||||
| Normal | 43 (53.1%) | 42 (72.4%) | 44 (57.1%) | 129 (59.7%) | |
| Grade 1 | 19 (23.5%) | 8 (13.8%) | 25 (32.5%) | 52 (24.1%) | |
| Grade 2 | 18 (22.2%) | 7 (12.1%) | 8 (10.4%) | 33 (15.3%) | |
| Grade 3 | 1 (1.2%) | 1 (1.7%) | 0 (0.0%) | 2 (0.9%) | |
| Fatigue | 0.06 | ||||
| Normal | 14 (17.3%) | 18 (31.0%) | 25 (32.5%) | 57 (26.4%) | |
| Grade 1 | 22 (27.2%) | 21 (36.2%) | 29 (37.7%) | 72 (33.3%) | |
| Grade 2 | 40 (49.4%) | 14 (24.1%) | 20 (26.0%) | 74 (34.3%) | |
| Grade 3 | 5 (6.2%) | 5 (8.6%) | 3 (3.9%) | 13 (6.0%) | |
| Headache | 0.0002 | ||||
| Normal | 12 (14.8%) | 26 (44.8%) | 34 (44.2%) | 72 (33.3%) | |
| Grade 1 | 32 (39.5%) | 18 (31.0%) | 18 (23.4%) | 68 (31.5%) | |
| Grade 2 | 32 (39.5%) | 13 (22.4%) | 23 (29.9%) | 68 (31.5%) | |
| Grade 3 | 5 (6.2%) | 1 (1.7%) | 2 (2.6%) | 8 (3.7%) |
Analysis of variance (ANOVA) for grade (including, “normal,” as grade 0) used to test for difference between age groups (global test across age groups).