Drugs / PXVX0200
PXVX0200
also known as
Vaxchora · CVD 103-HgR · Cholera vaccine · Cholera vaccine cvd 103-hgr · Cholera vaccine live oral · Cvd hgr 103 vaccine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vaxchora | — | 2020-04-01 | europa.eu ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01585181 | Apr → Aug 2012 | cholera | Bavarian Nordic | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03251495 | Aug 2017 → Dec 2024 | cholera | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT02145377 | Jul 2014 → Mar 2015 | cholera | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 33 trials · 3 met primary | ||||||
| Phase 3 | NCT02100631 | May 2014 → Feb 2015 | cholera | Bavarian Nordic | Completed | Met primary |
| Phase 3 | NCT02094586 | May 2014 → Feb 2015 | cholera | Bavarian Nordic | Completed | Met primary |
| Phase 3 | NCT01895855 | Sep 2013 → Nov 2014 | cholera | Bavarian Nordic | Completed | Met primary |
| Phase 43 trials · 1 met primary | ||||||
| Phase 4 | NCT03705585 | Nov 2018 → May 2029 expected | — | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| Phase 4 | NCT03724357 | Nov 2018 → Oct 2021 | — | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT03220737 | Jul 2017 → Sep 2019 | cholera | Bavarian Nordic | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-01-31 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives Positive CHMP Opinion for Vaxchora; Anticipates Near-Term Approval by European Medicines Agency emergentbiosolutions.com ↗
Emergent is pleased with receiving CHMP positive opinion, which brings us a step closer to providing a single-dose vaccine to address this travel health threat. |
| 2019-06-04 | Emergent BioSolutions | Regulatory Emergent BioSolutions Announces FDA Approval of Change in Storage Conditions and Transfer of Manufacturing for Its Cholera Vaccine emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) today announced approval by the U.S. Food and Drug Administration (FDA) of the Prior Approval Supplement (PAS) submitted by the company for its oral cholera vaccine, Vaxchora® (Cholera Vaccine, Live, Oral). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-01-31 | Emergent BioSolutions | Emergent BioSolutions Receives Positive CHMP Opinion for Vaxchora; Anticipates Near-Term Approval by European Medicines Agency emergentbiosolutions.com ↗ |
| 2019-06-04 | Emergent BioSolutions | Emergent BioSolutions Announces FDA Approval of Change in Storage Conditions and Transfer of Manufacturing for Its Cholera Vaccine emergentbiosolutions.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PXVX0200 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01585181 ↗ |
| Known as | Cholera vaccine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108939 ↗ |
| Known as | Cholera vaccine cvd 103-hgr | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108939 ↗ |
| Known as | Cholera vaccine live oral | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108939 ↗ |
| Known as | CVD 103-HgR | “The attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR, re-developed as PXVX0200, elicits a rapid serum vibriocidal antibody (SVA) response and protects...” PMID 29317118 ↗ Jan 20182“A Phase 1 Randomized, Double-Blind Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the LIve Oral Cholera Vaccine Candidate PXVX0200 Vibrio Cholerae...” NCT01585181 ↗ “PXVX0200 (CVD 103-HgR) Live Oral Cholera Vaccine” NCT02145377 ↗ |
| Known as | Cvd hgr 103 vaccine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108939 ↗ |
| Known as | Vaxchora | “The purpose of this study is to look at the immune responses to the FDA approved cholera vaccine (Vaxchora®).” NCT03251495 ↗ |
| Modality | Vaccine | “Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200” NCT01585181 ↗ |
| Route | Oral | “Healthy young adults were randomized (5:1 vaccinees to placebo recipients) to receive a single oral dose of ∼4.4 × 10(8) CFU of vaccine or a placebo” PMID 24173028 ↗ Oct 2013 |