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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01190228 | Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV | PHASE3 | COMPLETED | 454 | — | — | Aug 25, 2010 | Oct 12, 2015 | Mar 28, 2022 | 1 | Philippines |
The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or participants with pre vaccination titer ≥10 (1/dilution) and a ≥4-fold increase from pre- to post-vaccination.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Flavivirus positive was defined as titers against JE virus ≥10 (1/dilution) or titers against at least 1 dengue serotype ≥10 (1/dilution). Flavivirus negative was defined as titers against JE virus \<10 (1/dilution) and titers against the 4 dengue serotypes \<10 (1/dilution).
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Days 7 and 28 and Years 1, 2, 3, 4, and 5) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site reactions: Pain, Incapacitating, unable to perform usual activities. Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, 39.0°C; Headache, Malaise, and Myalgia, Significant; prevents daily activities.
| Arm | Type | Description |
|---|---|---|
| Group 1: JE-CV Vaccine Booster | EXPERIMENTAL | Participants previously vaccinated with JE-CV vaccine will receive a booster dose of JE-CV vaccine on Day 0. |
| Group 2: JE-CV Vaccine First Dose | EXPERIMENTAL | JE-CV vaccine naïve participants will receive a single dose of JE-CV vaccine on Day 0. |
| Group 3: Varicella Vaccine | ACTIVE_COMPARATOR | JE-CV vaccine naïve participants will receive one dose of Varicella vaccine on Day 0. |
| Name | Type | Description |
|---|---|---|
| JE-CV Vaccine | BIOLOGICAL | 0.5 mL (single dose), Subcutaneous |
| Varicella Vaccine | BIOLOGICAL | 0.5 mL (single dose), Subcutaneous |
An individual had to fulfill all of the following criteria in order to be eligible for trial enrollment: All Participants * Aged 36 to 42 months on the day of inclusion * Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative * Participant and p...