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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00314145 | A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX | PHASE3 | COMPLETED | 820 | — | — | Nov 1, 2005 | Nov 1, 2006 | Dec 6, 2012 | 10 | United States, Australia |
| NCT00441259 | Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age | PHASE2 | COMPLETED | 96 | — | — | Jan 1, 2007 | Dec 1, 2011 | Aug 27, 2012 | 3 | India |
| NCT00319592 | A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX | PHASE2 | COMPLETED | 60 | — | — | May 1, 2005 | Sep 1, 2006 | Aug 20, 2012 | 1 | United States |
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported. Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of \< 1:10.
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. \[Seropositive status can be 'Yes' or 'No'\]
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.
| Arm | Type | Description |
|---|---|---|
| ChimeriVax™-JE | EXPERIMENTAL | Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms. |
| JE-VAX® | ACTIVE_COMPARATOR | Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30. |
| JE-CV Group | EXPERIMENTAL | Participants will receive Japanese encephalitis chimeric virus vaccine (JE-CV) |
| MBDV Group | ACTIVE_COMPARATOR | Participants will receive the mouse brain-derived vaccine (MBDV) |
| Name | Type | Description |
|---|---|---|
| ChimeriVax™-JE | BIOLOGICAL | 0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline) |
| JE-VAX® | BIOLOGICAL | 0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline) |
| Japanese Encephalitis Inactivated Mouse Brain Vaccine | BIOLOGICAL | Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged \> 3 years and 0.5 ml is given to children and infants aged \< 3 years administered subcutaneously |
| ChimeriVax™-JE vaccine | BIOLOGICAL | 0.5 mL, subcutaneously |
| JE-VAX® vaccine | BIOLOGICAL | 1.0 mL, subcutaneously |
Inclusion Criteria: * Subjects aged 18 or above * Subjects in good general health. * Females must have negative pregnancy test and be using adequate form of contraception Exclusion Criteria: * History of vaccination/infection with JE or Yellow fever or other flaviviruses * History of residence/tr...