Table 2.
Demographic and Baseline Data for the Total Vaccinated Cohort (TVC) and According-to-Protocol (ATP) Cohort for Immunogenicity
| MMR-RIT-1 |
MMR-RIT-2 |
MMR-RIT-3 |
MMRII |
Total |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| TVC N = 304 | ATP N = 261 | TVC N = 304 | ATP N = 254 | TVC N = 304 | ATP N = 251 | TVC N = 308 | ATP N = 260 | TVC N = 1220 | ATP N = 1026 | ||
| Age (mo), mean (SD) | 12.4 (0.75) | 12.4 (0.69) | 12.4 (0.73) | 12.4 (0.73) | 12.2 (0.56) | 12.2 (0.57) | 12.4 (0.75) | 12.4 (0.73) | 12.3 (0.71) | 12.3 (0.69) | |
| Gender | Female, n (%) | 156 (51.3) | 134 (51.3) | 144 (47.4) | 120 (47.2) | 157 (51.6) | 128 (51.0) | 139 (45.1) | 118 (45.4) | 596 (48.9) | 500 (48.7) |
| Male, n (%) | 148 (48.7) | 127 (48.7) | 160 (52.6) | 134 (52.8) | 147 (48.4) | 123 (49.0) | 169 (54.9) | 142 (54.6) | 624 (51.1) | 526 (51.3) | |
| Pre-vaccination status of ATP cohort for immunogenicity, no. of seronegative subjects (%)a | |||||||||||
| Antibody (cut-off point) | MMR-RIT-1 N = 261b | MMR-RIT-2 N = 254b | MMR-RIT-3 N = 251b | MMRII N = 260b | Total N = 1026b | ||||||
| Measles (<150 mIU/mL) | 259/259 (100) | 253/253 (100) | 249/249 (100) | 258/258 (100) | 1019/1019 (100) | ||||||
| Mumps (ED50 <24) | 216/252 (85.7) | 219/248 (88.3) | 213/246 (86.6) | 213/243 (86.6) | 861/999 (86.2) | ||||||
| Rubella (<4 IU/mL) | 259/259 (100) | 251/252 (99.6) | 248/249 (99.6) | 258/258 (100) | 1016/1018 (99.8) | ||||||
Abbreviations: MMR, measles-mumps-rubella; N, total number of subjects; SD, standard deviation.
aCalculated for subjects in TVC for which pre-vaccination status was known (ie, % = n/[n + seropositive] × 100, where n = no. of seronegative subjects).
bNumber of subjects regardless of the status of baseline detection of antibody (ie, sum of seronegative, seropositive, and unknown).