Table 2.
Seropositive and seroconversion rates of enterovirus 71 (EV71), measles, mumps, rubella, and Japanese encephalitis (JE) antibody pre and post vaccination, per-protocol sets
| Variable | Group 1 |
Group 2 or Group 3 |
P value | ||
|---|---|---|---|---|---|
| n (%) | 95% CI | n (%) | 95% CI | ||
| EV71 neutralizing antibody (N) | 110 | 112 | |||
| Seropositive pre-vaccination | 4 (3.64) | (3.52,6.89) | 6 (5.36) | (5.18,8.50) | .768 |
| Seropositive post-vaccination | 109 (99.09) | (95.04,99.98) | 112 (100) | (96.76,100.00) | .495 |
| Seroconversion | 107 (97.27) | (92.24,99.43) | 109 (97.32) | (92.37,99.44) | 1.000a |
| Measles IgG antibody (N) | 110 | 116 | |||
| Seropositive pre-vaccination | 0 (0.00) | (0.00,3.37) | 0 (0.00) | (0.00,3.21) | - |
| Seropositive post-vaccination | 108 (98.18) | (93.59,99.78) | 115 (99.14) | (95.29,99.98) | .963 |
| Seroconversion | 108 (98.18) | (93.59,99.78) | 115 (99.14) | (95.29,99.98) | .963 |
| Mumps IgG antibody (N) | 110 | 116 | |||
| Seropositive pre-vaccination | 2 (1.82) | (1.76,5.13) | 3 (2.59) | (2.51,5.71) | 1.000 |
| Seropositive post-vaccination | 107 (97.27) | (92.24,99.43) | 111 (95.69) | (90.23,98.59) | .777 |
| Seroconversion | 106 (96.36) | (90.95,99.00) | 109 (93.79) | (87.96,97.54) | .402 |
| Rubella IgG antibody (N) | 110 | 116 | |||
| Seropositive pre-vaccination | 0 (0.00) | (0.00,3.37) | 2 (1.72) | (1.66,4.87) | .498 |
| Seropositive post-vaccination | 105 (95.45) | (89.71,98.51) | 112 (96.55) | (91.41,99.05) | .935 |
| Seroconversion | 105 (95.45) | (89.71,98.51) | 110 (94.83) | (89.08,98.08) | .827 |
| JE neutralizing antibody (N) | 110 | 116 | |||
| Seropositive pre-vaccination | 6 (5.45) | (2.03,11.49) | 3(2.59) | (0.54,7.37) | - |
| Seropositive post-vaccination | 96 (87.27) | (79.57,92.86) | 103(88.79) | (81.60,93.90) | .725 |
| Seroconversion | 90 (81.82) | (73.33,88.53) | 100 (86.21) | (78.57,91.91) | .368 |
Study groups were as follows: simultaneous receipt of enterovirus 71 (EV71) vaccine (dose 1) and measles-mumps-rubella vaccine (MMR) on d 0 and EV71 vaccine (dose 2) and live-attenuated Japanese encephalitis vaccine (LA-JEV) on d 30 (Group 1); receipt of MMR and LA-JEV on d 0 and 30, respectively (Group 2); or receipt of doses 1 and 2 of EV71 vaccine on d 0 and 30, respectively (Group 3).
aNon-inferiority was achieved, as the lower bound of the two-sided 95% CI was > − 10%.