Shanchol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Dukoral | — | 2004-04-28 | europa.eu ↗ |
Trials 20 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07270796 Comparator | Jan → Jul 2027 expected | vaccinia | International Vaccine Institute | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT01981616 Background | Sep 2011 → May 2012 | inflammatory bowel disease | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02823899 Comparator | Jul 2016 → Nov 2017 | cholera | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT02742558 Comparator | Apr 2016 → Jun 2017 | cholera | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | No outcome recorded |
| Phase 2 | NCT02145377 Comparator | Jul 2014 → Mar 2015 | cholera | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 2 | NCT01042951 Comparator | Jan → Aug 2010 | — | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05507229 Comparator | Feb → Jul 2022 | cholera | Bharat Biotech International Limited | Unknown | No outcome recorded |
| Phase 3 | NCT04760236 Comparator | Oct 2021 → Dec 2022 | cholera | International Vaccine Institute | Completed | No outcome recorded |
| Phase 3 | NCT02164110 Comparator | May → Sep 2014 | — | EuBiologics Co.,Ltd | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03373669 Comparator | Nov 2017 → Oct 2019 | cholera | Johns Hopkins Bloomberg School of Public Health | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT02924246 Comparator | Aug → Dec 2016 | infectious disease | NIZO Food Research | Completed | No outcome recorded |
| — | NCT01811771 Comparator | Aug 2012 → Aug 2015 | cholera | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | No outcome recorded |
| — | NCT01339845 Comparator | Sep 2009 → Dec 2016 | cholera | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Shanchol | “This open-label study assessed the safety and immunogenicity of two doses (14 days apart) of an indigenously manufactured, killed, bivalent (Vibrio cholerae O1 and O139),...” PMID 31211792 ↗ Jun 201923“Advantages of the Shanchol™ vaccine include that its cost is lower and does not require administration with buffer, thus making it more feasible for use in mass vaccination...” NCT02027207 ↗ “OCV has recently been introduced to Zambia where a large population was vaccinated with 1 dose of Shanchol®, and about 6 months later over 70% individuals traced to receive a...” NCT04423159 ↗ “Another whole cell killed OCV, ShancholTM, which is WHO prequalified, is based on similar bacterial components as Dukoral and licensed in India but not in Bangladesh.” NCT02742558 ↗ “Shanchol is a bivalent (O1 and O139 serotypes) vaccine using a heat-killed classical Inaba strain and a formalin-killed classical Ogawa strain produced by Sanofi.” NCT03373669 ↗ “We evaluated the effect of a killed OCV, Shanchol™, on pregnancy outcomes during an effectiveness trial of the vaccine in urban Bangladesh.” PMID 28196715 ↗ Feb 2017 “The oral cholera vaccine (OCV), Shanchol™ has shown protective efficacy lasting up to 5 years” PMID 26896684 ↗ Feb 2016 “Shanchol™, an inactivated oral cholera vaccine (OCV) is currently in use globally.” PMID 36136760 ↗ Jan 2023 “The OCV to be used in the trial is Shanchol.” NCT03719066 ↗ |
| Known as | Bivalent killed oral cholera vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00548054 ↗ |
| Known as | Bivalent oral killed cholera vaccine | “Bivalent oral killed cholera vaccine: each dose of this vaccine contains:” NCT00119197 ↗ |
| Known as | cholera vaccination | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02924246 ↗ |
| Known as | Dukoral | “The oral cholera vaccine Dukoral will be administered to all study participants in two doses,two weeks between doses.” NCT00464867 ↗5“Oral cholera vaccine (Dukoral®) on Days 0 and 7.” NCT06104345 ↗ |
| Known as | killed whole cell oral cholera vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00119197 ↗ |
| Known as | OCV | “some individuals who receive inactivated oral cholera vaccine (OCV) will develop antibody responses which predict protection against V. cholerae infection” NCT06455852 ↗ |
| Known as | Oral cholera vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01981616 ↗ |
| Known as | oral killed bivalent cholera vaccine | “The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West...” NCT00119197 ↗ |
| Known as | rBS-WC vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00709410 ↗ |
| Known as | ShancholTM | “Another whole cell killed OCV, ShancholTM, which is WHO prequalified, is based on similar bacterial components as Dukoral and licensed in India but not in Bangladesh.” NCT02742558 ↗ |
| Modality | Vaccine | “oral killed bivalent cholera vaccine” NCT00119197 ↗ |
| Route | Oral | “each 1.5 mL dose given orally” NCT00119197 ↗ |