Table 5.
Incidence of Solicited Injection Site (Days 0; 3) and General Symptoms During the 43-Day Post-vaccination Period (Total Vaccinated Cohort)
| Symptom | MMR-RIT-1 (N = 283) |
MMR-RIT-2 (N = 275) |
MMR-RIT-3 (N = 283) |
MMRII (N = 277) |
||||
|---|---|---|---|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | |
| Days 0; 3 | ||||||||
| Pain | 70 | 24.8 (19.9; 30.3) | 70 | 25.5 (20.5; 31.1) | 79 | 28.0 (22.9; 33.6) | 67 | 24.5 (19.5; 30.0) |
| Redness | 45 | 16.0 (11.9; 20.8) | 47 | 17.2 (12.9; 22.1) | 41 | 14.5 (10.6; 19.2) | 47 | 17.2 (12.9; 22.1) |
| Swelling | 20 | 7.1 (4.4; 10.7) | 26 | 9.5 (6.3; 13.6) | 19 | 6.7 (4.1; 10.3) | 15 | 5.5 (3.1; 8.9) |
| Days 0; 14 | ||||||||
| Irritability/fussiness | 180 | 63.6 (57.7; 69.2) | 141 | 51.3 (45.2; 57.3) | 150 | 53.0 (47.0; 58.9) | 153 | 55.2 (49.2; 61.2) |
| Drowsiness | 133 | 47.0 (41.1; 53.0) | 106 | 38.5 (32.8; 44.6) | 113 | 39.9 (34.2; 45.9) | 109 | 39.4 (33.6; 45.4) |
| Loss of appetite | 111 | 39.2 (33.5; 45.2) | 77 | 28.0 (22.8; 33.7) | 110 | 38.9 (33.2; 44.8) | 94 | 33.9 (28.4; 39.8) |
| Fever (rectal temp. ≥38.0°C) | 65 | 23.0 (18.2; 28.3) | 79 | 28.7 (23.5; 34.5) | 64 | 22.6 (17.9; 27.9) | 56 | 20.2 (15.6; 25.4) |
| Fever (rectal temp. >39.5°C) | 10 | 3.5 (1.7; 6.4) | 7 | 2.5 (1.0; 5.2) | 9 | 3.2 (1.5; 6.0) | 8 | 2.9 (1.3; 5.6) |
| Days 0; 42 | ||||||||
| Fever (rectal temp. ≥38.0°C) | 103 | 36.4 (30.8; 42.3) | 104 | 37.8 (32.1; 43.8) | 104 | 36.7 (31.1; 42.7) | 85 | 30.7 (25.3; 36.5) |
| Fever (rectal temp. >39.5°C) | 20 | 7.1 (4.4; 10.7) | 14 | 5.1 (2.8; 8.4) | 18 | 6.4 (3.8; 9.9) | 13 | 4.7 (2.5; 7.9) |
| Localized/generalized rash | 72 | 25.4 (20.5; 30.9) | 74 | 26.9 (21.8; 32.6) | 60 | 21.2 (16.6; 26.4) | 69 | 24.9 (19.9; 30.4) |
| Parotid gland swelling | 3 | 1.1 (0.2; 3.1) | 3 | 1.1 (0.2; 3.2) | 5 | 1.8 (0.6; 4.1) | 2 | 0.7 (0.1; 2.6) |
Abbreviations: MMR, measles-mumps-rubella; N, number of subjects having received the documented dose; n/%, number/percentage of subjects reporting a specified symptom; 95% CI, exact 95% confidence interval.