Overview
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Indication
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Associated Conditions
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Research Report
A Comprehensive Monograph on the Japanese Encephalitis Vaccine, Inactivated, Adsorbed (Ixiaro®)
Executive Summary
This report provides an exhaustive analysis of the Japanese Encephalitis Vaccine, Inactivated, Adsorbed (DrugBank ID: DB17795), commercially known as Ixiaro®. The vaccine represents a critical tool in the prevention of Japanese encephalitis (JE), a mosquito-borne viral disease with a significant public health burden across Asia and the Western Pacific. While the majority of Japanese encephalitis virus (JEV) infections are asymptomatic, the development of neuroinvasive disease, though rare, is catastrophic, with a case-fatality rate of 20-30% and a high incidence of permanent neurological sequelae among survivors. The absence of a specific antiviral therapy underscores the paramount importance of prevention through vaccination.
Ixiaro® is a modern, second-generation vaccine developed to replace older, mouse brain-derived products that were associated with significant safety concerns. It is a purified, inactivated vaccine based on the JEV strain SA14-14-2, propagated in a Vero cell culture substrate. This technological platform ensures a highly purified, consistent product with a superior safety and tolerability profile. The virus is inactivated with formaldehyde and formulated with a hydrated aluminum hydroxide adjuvant to potentiate the immune response.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/08 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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IXIARO Suspension for Injection 0.5ml in pre-filled syringe | SIN14108P | INJECTION, SUSPENSION | 6 μg/0.5 mL | 2/16/2012 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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