Table 3. Pooled Results: Incidence of Solicited General Adverse Events specific to Coadministered Measles-Mumps-Rubella and Varicella Vaccines reported within the 43-d Post-Vaccination Period following the Fourth Dose (Total Vaccinated Cohort).
| |
HibMenCY-TT Group |
|
Hib-OMP Group |
|
|
|
|||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Symptom | Severity | N | n | % | N | n | % | Relative Riska (95% CI) | P-Value | ||
| Meningeal signs/ febrile convulsion |
All |
1163 |
0 |
0 |
|
374 |
0 |
0 |
|
NC |
NC |
| Grade 3 |
1163 |
0 |
0 |
|
374 |
0 |
0 |
|
NC |
NC |
|
| Parotid/salivary gland swelling |
All |
1163 |
4 |
0.3 |
|
374 |
0 |
0 |
|
INF (0.21, INF) |
0.653 |
| Grade 3 |
1163 |
2 |
0.2 |
|
374 |
0 |
0 |
|
INF (0.06, INF) |
1.000 |
|
| Fever |
All |
1167 |
535 |
45.8 |
|
374 |
182 |
48.7 |
|
0.94 (0.80, 1.12) |
0.522 |
| |
> 38.5°C |
1167 |
339 |
29.0 |
|
374 |
114 |
30.5 |
|
0.95 (0.77, 1.19) |
0.700 |
| |
> 39.0°C |
1167 |
191 |
16.4 |
|
374 |
58 |
15.5 |
|
1.06 (0.78, 1.44) |
0.778 |
| |
> 39.5°C |
1167 |
84 |
7.2 |
|
374 |
29 |
7.8 |
|
0.93 (0.60, 1.47) |
0.806 |
| |
> 40.0°C |
1167 |
20 |
1.7 |
|
374 |
7 |
1.9 |
|
0.92 (0.37, 2.57) |
0.994 |
| Rash |
All |
1166 |
291 |
25.0 |
|
376 |
85 |
22.6 |
|
1.11 (0.87, 1.42) |
0.455 |
| Grade 3 | 1166 | 38 | 3.3 | 376 | 10 | 2.7 | 1.23 (0.60, 2.76) | 0.702 | |||
a
HibMenCY-TT over Hib-OMP. N indicates number of subjects with the documented dose; n/%, number/percentage of subjects reporting a specified symptom; NC, not calculated because no events reported; INF, infinity. P-value, 2-sided Exact Stratified Test conditional to number of cases; fever, rectal or axillary/tympanic temperature ≥ 38.0°C. Grade 3: meningeal signs/febrile convulsion that prevented normal, everyday activities; parotid/salivary gland swelling, with accompanying general symptoms; temperature > 40.0°C; rash with 200 or more papules, vesicles and/or crusts.