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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00981630 | Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine | PHASE2 | COMPLETED | 128 | — | — | Nov 1, 2004 | Nov 1, 2007 | Dec 5, 2012 | 2 | Australia |
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.
| Arm | Type | Description |
|---|---|---|
| ChimeriVax™-JE Dose Level 1 | EXPERIMENTAL | Participants received ChimeriVax™-JE (Japanese Encephalitis) a dose of 3.0 log10 Plaque-forming units (PFU) on Day 0. |
| ChimeriVax™-JE Dose Level 2 | EXPERIMENTAL | Participants received ChimeriVax™-JE a dose of 4.0 log10 PFU on Day 0. |
| ChimeriVax™-JE Dose Level 3 | EXPERIMENTAL | Participants received ChimeriVax™-JE a dose of 5.0 log10 PFU on Day 0. |
| Placebo | PLACEBO_COMPARATOR | Participants received ChimeriVax diluent, 0.5 mL on Day 0. |
| Name | Type | Description |
|---|---|---|
| Live attenuated Japanese encephalitis virus | BIOLOGICAL | 0.5 mL,Subcutaneous |
| ChimeriVax™ diluent (Placebo) | BIOLOGICAL | 0.5 mL, Subcutaneous |
Inclusion Criteria : * All aspects of the protocol explained and written informed consent obtained from the participant. * Aged ≥18 to \< 49 years. * In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results. * ...