12 completed, 3 unknown, 1 withdrawn. 7 Phase 2, 5 Phase 4, 3 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 4, Unknown 2, Withdrawn 1 |
| Phase 4 | 5 | Completed 4, Unknown 1 |
| Phase 1 | 3 | Completed 1, Unknown 1, Withdrawn 1 |
| Phase 3 | 2 | Completed 2 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| Bridging Study for Killed Oral Cholera Vaccine in Ethiopia Killed Bivalent (O1 and O139) whole cell oral cholera vaccine, Placebo - Vibrio Cholerae, Cholera | Phase 4 | Completed | International Vaccine Institute | 216 | 2012-12-01 | 2015-05-04 |
| 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 |
| Pilot Introduction of Oral Cholera Vaccine in Orissa, India Cholera | Completed | International Vaccine Institute | 31552 | 2011-05-01 | 2013-05-23 | |
| Study of Alternative Vaccination Schedule of Oral Cholera Vaccine Modified killed oral cholera vaccine at 14 day interval, Modified killed oral cholera vaccine at 28 day interval - Cholera, Diarrhoea | Phase 2 | Completed | International Vaccine Institute | 386 | 2010-12-01 | 2013-09-25 |
| Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine, Placebo - Rotavirus Gastroenteritis | Phase 1 / Phase 2 | Unknown | Shantha Biotechnics Limited | 90 | 2010-07-01 | 2010-10-04 |
| A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV), Placebo - Rotavirus Gastroenteritis | Phase 1 | Completed | Shantha Biotechnics Limited | 20 | 2010-04-01 | 2011-06-08 |
| Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV], Placebo - Rotavirus Infections | Phase 1 / Phase 2 | Withdrawn | Shantha Biotechnics Limited | 240 | 2009-09-01 | 2010-02-03 |
| Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine Shan 5 - Diphtheria, Tetanus | Phase 4 | Unknown | Shantha Biotechnics Limited | 3000 | 2009-01-01 | 2009-05-06 |
| Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine Shan5 - Diphtheria, Tetanus | Phase 4 | Completed | Shantha Biotechnics Limited | 160 | 2008-03-01 | 2009-06-25 |
| Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine Shan 5, Easy Five - Diphtheria, Tetanus | Phase 4 | Completed | Shantha Biotechnics Limited | 144 | 2008-03-01 | 2009-06-25 |
| Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF) Recombinant Human GCSF (Shantha Biotechnics Limited), Neupogen - Chemotherapy-Induced Neutropenia | Phase 3 | Completed | Shantha Biotechnics Limited | 126 | 2007-10-01 | 2010-02-03 |
| Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine Killed bivalent whole cell oral cholera vaccine, Heat Killed E. coli Placebo - Cholera, Diarrhea | Phase 2 | Completed | International Vaccine Institute | 160 | 2007-06-01 | 2009-12-07 |
| Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata bivalent killed whole cell oral cholera vaccine, Placebo - Diarrhea, Cholera | Phase 3 | Completed | International Vaccine Institute | 69329 | 2006-07-01 | 2014-07-31 |
| Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata killed whole cell oral cholera vaccine, Heat Killed E. coli - Cholera | Phase 2 | Completed | International Vaccine Institute | 200 | 2005-08-01 | 2008-07-04 |
Cholera (9) · Diarrhea (4) · Vibrio Infections (4) · Diphtheria (3) · Haemophilus Infections (3) · Hepatitis B (3) · Tetanus (3) · Whooping Cough (3) · Rotavirus Infections (1)
shanchol (3) · Filgrastim (1)
India (14) · Ethiopia (1) · Mali (1)
Raman Rao, MD (7) · Alok K Deb, PhD, MDDS (1) · Dipika Sur, MD (1) · Dipika Sur, MD, DPH (1) · Milagritos D Tapia, MD (1) · Samba O Sow, MD, MS (1) · Shantanu K Kar, MD (1) · Sujit K Bhattacharya (1) · Sujit K Bhatttacharya, MD (1) · Venkata R Mohan, M.D., MPH (1)
PMID 19761838, PMID 19819004, PMID 22028938, PMID 23362293, PMID 26078323, PMID 27622507, PMID 29021299, PMID 29463233, PMID 31211792, PMID 38023545