drugset / Trial / NCT00548054
Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants
Phase 2
Unknown
300 enrolled
International Vaccine Institute
Indian Council of Medical Research · collabInstitute of Child Health · collabNational Institute of Cholera and Enteric Diseases, India · collabShantha Biotechnics Limited · collab
RandomizedSingle-groupQuadruple-blindPrevention
Summary
In order to assess whether the bivalent killed oral cholera vaccine may be used safely among infants who are most at risk for cholera, the investigators need to determine the safety and immunogenicity of the killed oral cholera vaccine among infants less than 1 year of age when given with the expanded program on immunization (EPI) vaccines including diptheria, pertussis and tetanus (DPT), oral polio vaccine (OPV), Hepatitis B vaccines and measles vaccine. Furthermore, the investigators also need to make sure that immune interference does not occur among all the other vaccine antigens given at the same time. Findings from this study will pave the way for the possible use of the killed whole cell oral cholera vaccine (OCV).
Timeline
- Start
- 2015-12
- Primary completion
- 2016-08
- Completion
- 2016-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Shanchol | Vaccine | 1.5 ml | Oral |