15 completed, 1 terminated, 1 unknown. 6 Phase 2, 4 Phase 3, 4 Phase 4, 2 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 5, Unknown 1 |
| Phase 3 | 4 | Completed 4 |
| Phase 4 | 4 | Completed 4 |
| Not applicable | 2 | Completed 1, Terminated 1 |
| Phase 1 | 1 | Completed 1 |
Follow shanchol: new trials by email Literature Review of shanchol trials Research Report on shanchol
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™ Oral Cholera Vaccine Simplified (OCV-S), Shanchol™ - Cholera | Phase 3 | Completed | International Vaccine Institute | 2530 | 2021-10-06 | 2023-06-22 |
| Extended Dose Intervals With Oral Cholera Vaccine in Cameroon killed whole cell oral cholera vaccine - Adverse Reaction to Cholera Vaccine, Cholera Vaccination Reaction | Phase 2 | Completed | Johns Hopkins Bloomberg School of Public Health | 181 | 2018-10-23 | 2022-10-05 |
| Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine Oral Cholera Vaccine, Adjusted Dose Oral Cholera Vaccine - Cholera, Vibrio Cholerae Infection | Phase 4 | Completed | Johns Hopkins Bloomberg School of Public Health | 120 | 2017-11-16 | 2021-04-05 |
| Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine HL-OCV, Shanchol - Cholera | Phase 1 / Phase 2 | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | 840 | 2016-07-01 | 2018-11-02 |
| Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine Cholvax, Shanchol - Cholera | Phase 2 | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | 2052 | 2016-04-01 | 2017-06-16 |
| Cholera Vaccine Investment Strategy in Bangladesh Shanchol - Cholera | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | 75170 | 2016-01-01 | 2019-12-20 | |
| Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants Bivalent killed oral cholera vaccine, Killed Escherichia coli K12 placebo - Cholera, Diarrhea | Phase 2 | Unknown | International Vaccine Institute | 300 | 2015-12-01 | 2015-05-04 |
| Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje Malawi Shanchol - Miscarriage, Stillbirth | Not applicable | Terminated | Johns Hopkins Bloomberg School of Public Health | 2758 | 2015-06-01 | 2024-01-03 |
| A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican Republic Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell - Cholera | Phase 3 | Completed | Sanofi Pasteur, a Sanofi Company | 336 | 2015-04-01 | 2018-03-26 |
| PXVX0200 (CVD103-HgR) vs Shanchol in Mali PXVX0200 10E8, PXVX0200 10E9, Placebo - Cholera | Phase 2 | Completed | University of Maryland, Baltimore | 150 | 2014-07-01 | 2019-09-26 |
| To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children Euvichol, Shanchol - Prevention Harmful Effects | Phase 3 | Completed | EuBiologics Co.,Ltd | 3632 | 2014-05-01 | 2014-12-08 |
| A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell - Cholera | Phase 4 | Completed | Sanofi Pasteur, a Sanofi Company | 336 | 2014-03-01 | 2018-03-23 |
| Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh Shanchol, Placebo - Cholera | Phase 3 | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | 204438 | 2012-12-09 | 2018-03-20 |
| Evaluation of a Boosting Regimen With Oral Cholera Vaccine Shanchol™, oral cholera vaccine, Shanchol™, killed, whole cell, bivalent, oral cholera vaccine, no intervention - Cholera | Phase 4 | Completed | Sachin Desai | 426 | 2012-12-01 | 2013-09-25 |
| Field Application of Shanchol in Adults in Bangladesh Shanchol - Other Specified Effects of Reduced Temperature | Phase 2 | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | 1015 | 2012-06-01 | 2016-08-31 |
| A Study to Evaluate Safety and Immunogenicity of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Adults and Children killed bivalent (O1 and O139)whole cell oral cholera vaccine - Vibrio Cholerae | Phase 4 | Completed | International Vaccine Institute | 200 | 2012-03-01 | 2014-06-17 |
| Introduction of Cholera Vaccine in Bangladesh ShanChol, Vaccine and behaviour - Cholera | Not applicable | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | 240000 | 2009-09-01 | 2017-03-07 |
Cholera (15) · Abortion, Spontaneous (1) · Diarrhea (1) · Stillbirth (1) · Vibrio Infections (1)
International Centre for Diarrhoeal Disease Research, Bangladesh (6) · International Vaccine Institute (3) · Johns Hopkins Bloomberg School of Public Health (3) · Sanofi Pasteur, a Sanofi Company (2) · EuBiologics Co.,Ltd (1) · Sachin Desai (1) · University of Maryland, Baltimore (1)
Bangladesh (6) · India (3) · Philippines (2) · Cameroon (1) · Dominican Republic (1) · Mali (1) · Nepal (1) · United States (1) · Zambia (1)
Firdausi Qadri, Dr. (2) · Alok K Deb, PhD, MDDS (1) · Amanda K Debes, PhD (1) · Amit Saha, M.Med (1) · David Sack, MD (1) · Dr. Firdausi Qadri, PhD (1) · Julia Lynch, MD (1) · Milagritos D Tapia, MD (1) · Mohammad Ali, PhD (1) · Roberto A. Espos, MD (1) · Samba O Sow, MD, MS (1) · Suman Kanungo, MBBS (1) · Venkata R Mohan, M.D., MPH (1)
PMID 21907255, PMID 22461716, PMID 19761838, PMID 24161413, PMID 16760521, PMID 18398491, PMID 19819004, PMID 21346055, PMID 24101640, PMID 26164097, PMID 26896684, PMID 27144848, PMID 28161570, PMID 28196715, PMID 28910563, PMID 29021299, PMID 29470934, PMID 29550406, PMID 29752024, PMID 31092224, PMID 31211792, PMID 31879124, PMID 33215698, PMID 34146473, PMID 34217572, PMID 34218960, PMID 36130764, PMID 36715243, PMID 38614631, PMID 7148820