{"id":"shanchol-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Abdominal pain or discomfort"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Shanchol contains killed whole-cell Vibrio cholerae bacteria combined with recombinant cholera toxin B subunit. When administered orally, it triggers mucosal and systemic immune responses, inducing antibodies and cellular immunity against cholera toxin and bacterial surface antigens. This immune priming protects against infection by the two major pathogenic serogroups of V. cholerae.","oneSentence":"Shanchol is an oral, inactivated cholera vaccine that stimulates immune responses against Vibrio cholerae O1 and O139 antigens to prevent cholera infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:52:59.157Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of cholera caused by Vibrio cholerae O1 and O139 in endemic and epidemic settings"}]},"trialDetails":[{"nctId":"NCT02499172","phase":"NA","title":"Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje Malawi","status":"TERMINATED","sponsor":"Johns Hopkins Bloomberg School of Public Health","startDate":"2015-06","conditions":"Miscarriage, Stillbirth, Cholera","enrollment":2758},{"nctId":"NCT04760236","phase":"PHASE3","title":"Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™","status":"COMPLETED","sponsor":"International Vaccine Institute","startDate":"2021-10-06","conditions":"Cholera","enrollment":2530},{"nctId":"NCT05732766","phase":"PHASE3","title":"To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131)","status":"UNKNOWN","sponsor":"Bharat Biotech International Limited","startDate":"2023-02-04","conditions":"Cholera","enrollment":1800},{"nctId":"NCT03719066","phase":"PHASE2","title":"Extended Dose Intervals With Oral Cholera Vaccine in Cameroon","status":"COMPLETED","sponsor":"Johns Hopkins Bloomberg School of Public Health","startDate":"2018-10-23","conditions":"Adverse Reaction to Cholera Vaccine, Cholera Vaccination Reaction","enrollment":181},{"nctId":"NCT05507229","phase":"PHASE3","title":"A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate the Non-inferiority of Immunogenicity and Safety of Hillchol® (BBV131)to Shanchol™ Along With Lot-to-lot Consistency of Hillchol®(BBV131).","status":"UNKNOWN","sponsor":"Bharat Biotech International Limited","startDate":"2022-02-22","conditions":"Cholera","enrollment":1800},{"nctId":"NCT04423159","phase":"NA","title":"Immunological Characteristics of a Population at Risk of Cholera After Oral Cholera Vaccine (CHOVAXIM)","status":"COMPLETED","sponsor":"Centre for Infectious Disease Research in Zambia","startDate":"2016-10-16","conditions":"Diarrhea Infectious","enrollment":225},{"nctId":"NCT03581734","phase":"PHASE3","title":"Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine","status":"UNKNOWN","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2018-07-01","conditions":"Vaccine Reaction","enrollment":579},{"nctId":"NCT03373669","phase":"PHASE4","title":"Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine","status":"COMPLETED","sponsor":"Johns Hopkins Bloomberg School of Public Health","startDate":"2017-11-16","conditions":"Cholera, Vibrio Cholerae Infection","enrollment":120},{"nctId":"NCT02727855","phase":"","title":"Cholera Vaccine Investment Strategy in Bangladesh","status":"COMPLETED","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2016-01-01","conditions":"Cholera","enrollment":75170},{"nctId":"NCT02145377","phase":"PHASE2","title":"PXVX0200 (CVD103-HgR) vs Shanchol in Mali","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2014-07","conditions":"Cholera","enrollment":150},{"nctId":"NCT02823899","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine","status":"COMPLETED","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2016-07","conditions":"Cholera","enrollment":840},{"nctId":"NCT02434822","phase":"PHASE3","title":"A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican Republic","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2015-04","conditions":"Cholera","enrollment":336},{"nctId":"NCT01949675","phase":"PHASE4","title":"A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2014-03","conditions":"Cholera","enrollment":336},{"nctId":"NCT02027207","phase":"PHASE3","title":"Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh","status":"COMPLETED","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2012-12-09","conditions":"Cholera","enrollment":204438},{"nctId":"NCT02742558","phase":"PHASE2","title":"Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine","status":"COMPLETED","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2016-04","conditions":"Cholera","enrollment":2052},{"nctId":"NCT01339845","phase":"NA","title":"Introduction of Cholera Vaccine in Bangladesh","status":"COMPLETED","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2009-09","conditions":"Cholera","enrollment":240000},{"nctId":"NCT01762930","phase":"PHASE2","title":"Field Application of Shanchol in Adults in Bangladesh","status":"COMPLETED","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2012-06","conditions":"Other Specified Effects of Reduced Temperature","enrollment":1015},{"nctId":"NCT01811771","phase":"NA","title":"Oral Cholera Vaccine Delivery in Rural Bangladesh","status":"COMPLETED","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2012-08","conditions":"Cholera","enrollment":60000},{"nctId":"NCT01524640","phase":"PHASE4","title":"Bridging Study for Killed Oral Cholera Vaccine in Ethiopia","status":"COMPLETED","sponsor":"International Vaccine Institute","startDate":"2012-12","conditions":"Vibrio Cholerae, Cholera","enrollment":216},{"nctId":"NCT00548054","phase":"PHASE2","title":"Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants","status":"UNKNOWN","sponsor":"International Vaccine Institute","startDate":"2015-12","conditions":"Cholera, Diarrhea, Vibrio Infections","enrollment":300},{"nctId":"NCT02164110","phase":"PHASE3","title":"To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children","status":"COMPLETED","sponsor":"EuBiologics Co.,Ltd","startDate":"2014-05","conditions":"Prevention Harmful Effects","enrollment":3632},{"nctId":"NCT01042951","phase":"PHASE2","title":"To Determine the Safety and Immunogenicity of an Oral Whole Cell ShanChol Cholera Vaccine in Bangladesh","status":"COMPLETED","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2010-01","conditions":"Healthy","enrollment":330},{"nctId":"NCT00760825","phase":"PHASE4","title":"A Study to Evaluate Safety and Immunogenicity of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Adults and Children","status":"COMPLETED","sponsor":"International Vaccine Institute","startDate":"2012-03","conditions":"Vibrio Cholerae","enrollment":200},{"nctId":"NCT01579448","phase":"PHASE4","title":"Evaluation of a Boosting Regimen With Oral Cholera Vaccine","status":"COMPLETED","sponsor":"Sachin Desai","startDate":"2012-12","conditions":"Cholera","enrollment":426},{"nctId":"NCT01508507","phase":"","title":"Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine","status":"UNKNOWN","sponsor":"International Vaccine Institute","startDate":"2013-03","conditions":"Cholera","enrollment":240}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Shanchol vaccine","genericName":"Shanchol vaccine","companyName":"International Centre for Diarrhoeal Disease Research, Bangladesh","companyId":"international-centre-for-diarrhoeal-disease-research-bangladesh","modality":"Biologic","firstApprovalDate":"","aiSummary":"Shanchol is an oral, inactivated cholera vaccine that stimulates immune responses against Vibrio cholerae O1 and O139 antigens to prevent cholera infection. Used for Prevention of cholera caused by Vibrio cholerae O1 and O139 in endemic and epidemic settings.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}