Table 2.
| Vaccine component | Statistic |
Day 35 |
|||||
|---|---|---|---|---|---|---|---|
| DSJI (n = 161) | N-S (n = 157) | Two-sided p-value by Fisher’s Exact Test | DSJI (n = 161) | N-S (n = 157) | Difference in percentage^ | ||
| Measles | Seropositive subjects (%) | 100 (62.1) | 107 (68.2) | – | 157 (97.5) | 155 (98.7) | 1.2 |
| 2-Sided 95% CI | (54.1, 69.6) | (60.3, 75.4) | 0.2902 | (93.8, 99.3) | (95.5, 99.8) | (−4.0, 6.4) | |
| Mumps | Seropositive subjects (%) | 13 (8.1) | 10 (6.4) | – | 159 (98.8) | 155 (98.7) | −0.1 |
| 2-Sided 95% CI | (4.4, 13.4) | (3.1, 11.4) | 0.6665 | (95.6, 99.8) | (95.5, 99.8) | (−5.0, 4.9) | |
| Rubella | Seropositive subjects (%) | 7 (4.3) | 6 (3.8) | – | 159 (98.8) | 157 (100.0) | 1.2 |
| 2-Sided 95% CI | (1.8, 8.8) | (1.4, 8.1) | 1.0000 | (95.6, 99.8) | (97.7, 100.0) | (−3.7, 6.2) | |
IgG antibody titers were determined by ELISA (Trinity Biotech) for each vaccine component. Seropositivity was defined as IgG antibody titers ≥1.10 immune status ratio (ISR), according to the levels given in the Trinity Biotech kit. For measles and rubella, antibody titers were converted from ISR to IU/ml per instructions in the Trinity Biotech kits. For mumps, the ISR values were used. All samples were tested in duplicate and the mean of the two values was used. Repeat testing was performed on samples with equivocal results.
The per-protocol population consisted of all subjects who had no major protocol violations and who completed all three clinic visits, with evaluable blood samples at day 0 and day 35.
Two-sided 95% CI is estimated for the difference between proportions using the Farrington and Manning method. The upper limit of the two-sided 95% CI for the percentage of seropositivity for all vaccine components was less than 10%; thus, the seropositivity of the MMR DSJI group was non-inferior to that of the MMR N-S group.