Table 3.
Adverse experience (AE) summary (days 1 to 42 following each vaccination).
| MMRVAMP (N = 698) |
MMRV (N = 702) |
|||
|---|---|---|---|---|
| Parameter | n | (%) | n | (%) |
| After Dose-1 | ||||
| Subjects with follow-up | 682 | 682 | ||
| With one or more AE | 498 | (73.0) | 475 | (69.6) |
| With vaccine-related* AEs | 300 | (44.0) | 257 | (37.7) |
| Injection-site AEs† | 258 | (37.8) | 216 | (31.7) |
| Systemic AEs† | 81 | (11.9) | 71 | (10.4) |
| With serious AEs | 7 | (1.0) | 5 | (0.7) |
| Serious vaccine-related AEs | 1 | (0.1) | 2 | (0.3) |
| Who died‡ | 0 | (0.0) | 0 | (0.0) |
| Discontinued due to a serious vaccine-related AE | 1§ | (0.1) | 2║ | (0.3) |
| After Dose-2 | ||||
| Subjects with follow-up | 634 | 632 | ||
| With one or more AE | 412 | (65.0) | 419 | (66.3) |
| With vaccine-related* AEs | 245 | (38.6) | 218 | (34.5) |
| Injection-site AEs† | 227 | (35.8) | 188 | (29.7) |
| Systemic AEs† | 38 | (6.0) | 42 | (6.6) |
| With serious AEs | 2 | (0.3) | 2 | (0.3) |
| Serious vaccine-related AEs | 0 | (0.0) | 0 | (0.0) |
| Who died† | 0 | (0.0) | 0 | (0.0) |
| Discontinued due to a serious vaccine-related AE | 0 | (0.0) | 0 | (0.0) |
*
Determined by the investigator to be possibly, probably, or definitely related to the vaccine.
†
Includes those adverse experiences occurring with an overall incidence of 5% or more in the study population.
‡
No Subject died throughout the course of this study.
§
Subject was diagnosed with febrile convulsion and epilepticus (both severe intensity).
║
Subjects were diagnosed with (1) febrile convulsion (moderate intensity); and (2) idiopathic arthritis (moderate intensity).
N = Number of subjects randomized and vaccinated in the vaccination group.
n = Number of subjects in each category.
The same subject may appear in different categories, but counted only once in each category.