Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01900444 | Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea | PHASE3 | COMPLETED | 119 | — | — | Jul 11, 2013 | Mar 11, 2014 | Mar 28, 2022 | 8 | South Korea |
JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.
JE virus neutralizing antibodies were measured using PRNT50 test.
JE virus neutralizing antibodies were measured using PRNT50.
JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.
JE virus neutralizing antibodies were measured using PRNT50.
JE virus neutralizing antibodies were measured using PRNT50.
| Arm | Type | Description |
|---|---|---|
| IMOJEV Group | EXPERIMENTAL | Participants who received a single dose of IMOJEV in study JEC12 (NCT01396512) will receive a booster dose in this study. |
| Name | Type | Description |
|---|---|---|
| IMOJEV | BIOLOGICAL | 0.5 mL, Subcutaneous |
Inclusion Criteria: * Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months before booster vaccination * Age 2 to 4 years on the day of inclusion * In good general health at the time of inclusion * Informed Concent Form signed and dated by parent(s) or another legal...