Table 4.
Percentage of participants with unsolicited adverse events (Day 0–42) and serious adverse events (Day 0–180) (total vaccinated cohort).
| MMR-RIT (N = 454) |
MMR II (N = 457) |
|||
|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | |
| Unsolicited AEs (≥1 AE) | 95 | 20.9 (17.3, 25.0) | 82 | 17.9 (14.5, 21.8) |
| Grade 3 (≥1 AE) | 7 | 1.5 (0.6, 3.2) | 5 | 1.1 (0.4, 2.5) |
| Related (≥1 AE) | 12 | 2.6 (1.4, 4.6) | 15 | 3.3 (1.8, 5.4) |
| SAEs (any, ≥1 SAE) | 3 | 0.7 (0.1, 1.9) | 7 | 1.5 (0.6, 3.1) |
AE, adverse event; SAE, serious adverse event; N, number of participants with the administered dose; n/%, number/percentage of participants reporting a symptom at least once; CI, two-sided 95% confidence interval obtained using the Clopper Pearson method.
a
AEs of grade 3 intensity were those preventing normal, everyday activities.
b
Related AEs were considered by the investigator to be related or possibly related to the study vaccine.