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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00314132 | Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis. | PHASE3 | COMPLETED | 2,004 | — | — | Oct 1, 2005 | Nov 1, 2006 | Dec 6, 2012 | 22 | United States, Australia |
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | All subjects received a single injection of placebo on Day 0. |
| ChimeriVax™ JE 4 log10 PFU Vaccine | EXPERIMENTAL | All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0. |
| Name | Type | Description |
|---|---|---|
| ChimeriVax-JE, Japanese Encephalitis vaccine | BIOLOGICAL | 0.5 mL, Subcutaneous |
| 0.9% Saline | BIOLOGICAL | 0.5 mL, Subcutaneous |
Inclusion Criteria: * Informed consent obtained from the subject. * Aged 18 years or above at screening. * In good general health * Subject available for the study duration * For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0. Exclusion Criteria: * ...