Overview
Vibrio cholerae CVD 103-HgR strain live antigen is a component of Vaxchora, an oral vaccine for immunization against Vibrio cholerae serogroup O1. Cholera is an acute bacterial disease of the small intestine caused by Vibrio cholerae, which is gram-negative bacteria. Two serogroups of V. cholerae, O1 and O139, are causative agents of epidemic cholera. Serogroup O1 is responsible for the majority of cholera outbreaks. Cholera outbreaks remain a major global public health problem that mainly affects countries with limited access to clean water, poor hygiene, and proper sanitation; thus, effective vaccines to protect individuals against cholera disease are critical. The FDA approved the cholera vaccine containing Vibrio cholerae CVD 103-HgR strain live antigen under the brand name Vaxchora in June 2016, making it the first vaccine indicated for cholera prevention to become available in the U.S. Vaxchora was later approved by the European Commission in April 2020. It is indicated for individuals aged two years and older.
Indication
Vibrio cholerae CVD 103-HgR strain live antigen is indicated for active oral immunization against infection caused by Vibrio cholerae serogroup O1 in patients between 2 and 64 years of age.
Associated Conditions
- Cholera caused by Vibrio cholerae serogroup O1
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/10/27 | Phase 4 | Completed | |||
2018/10/30 | Phase 4 | Terminated | |||
2018/10/15 | Phase 4 | Recruiting | |||
2017/08/16 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
CHOLERA VACCINE STRAIN 35A-AND 41 8000M/CC | aventis pasteur limited | 00074969 | Suspension - Subcutaneous | 8000 M / ML | 12/31/1942 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.