Table 6.
Incidence of rash, parotid/salivary gland swelling, and febrile convulsions/headaches (Day 0–42) (total vaccinated cohort).
| Sub-cohort 1 |
Sub-cohort 2 |
Sub-cohort 3 |
||||
|---|---|---|---|---|---|---|
| n (%) | MMR-RIT (N = 731) |
MMR II (N = 268) |
MMR-RIT (N = 767) |
MMR II (N = 291) |
MMR-RIT (N = 1291) |
MMR II (N = 481) |
| Rash | ||||||
| Any rash | 61 (8.3) | 28 (10.4) | 37 (4.8) | 12 (4.1) | 56 (4.3) | 23 (4.8) |
| Grade 3 | 3 (0.4) | 0 (0.0) | 1 (0.1) | 0 (0.0) | 3 (0.2) | 0 (0.0) |
| Measles/rubella-like | 14 (1.9) | 5 (1.9) | 3 (0.4) | 2 (0.7) | 4 (0.3) | 2 (0.4) |
| Varicella-like* | 4 (0.5) | 3 (1.1) | - | - | - | - |
| Parotid/salivary gland swelling | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 1 (0.1) | 1 (0.2) |
| Grade 3 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Febrile convulsion/headaches | 0 (0.0) | 2 (0.7) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Grade 3 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
N, number of participants with the administered dose; n (%), number (percentage) of participants reporting the specified symptom.
Grade 3 was defined as: adverse event preventing normal, everyday activities (any rash, febrile convulsion/headaches); swelling with accompanying general symptoms (parotid/salivary gland swelling).
* Varicella-like rash was assessed only in sub-cohort 1 as a solicited adverse event of interest after varicella vaccine administration.