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ChimeriVax-JE, Japanese Encephalitis vaccine · 1 trial · 2 indications
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: * ...
ChimeriVax-JE vaccine is an investigational vaccine being developed for the prevention of Japanese Encephalitis, a viral infection that can cause encephalitis. It is designed for use in adults and children, with clinical trials conducted in the United States, Australia, and India.
ChimeriVax-JE vaccine is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. The vaccine is currently in clinical development and has not been approved for commercial use.
ChimeriVax-JE vaccine has completed Phase 3 clinical trials, which are the final stage of testing before seeking regulatory approval. However, it remains an investigational product and is not yet approved by regulatory authorities such as the FDA.
ChimeriVax-JE vaccine has completed three clinical trials: NCT00314132, a Phase 3 safety study with 2004 participants; NCT00314145, a Phase 3 safety and efficacy study with 820 participants; and NCT00319592, a Phase 2 study with 60 participants. All trials enrolled healthy adults aged 18 years and older.
ChimeriVax-JE vaccine is not the same as JE-VAX. Clinical trials NCT00314145 and NCT00319592 directly compared ChimeriVax-JE vaccine to JE-VAX, an inactivated mouse brain-derived Japanese Encephalitis vaccine, to evaluate their relative safety and efficacy.