drugset / Trial / NCT01579448
Evaluation of a Boosting Regimen With Oral Cholera Vaccine
Phase 4
Completed
426 enrolled
Sachin Desai
Indian Council of Medical Research · collabNational Institute of Cholera and Enteric Diseases, India · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection over 3 years and data regarding the protective efficacy over five years is anticipated for 2012. Regardless at the end of five years, it may still be necessary to provide a booster dose or reimmunize with two doses to maintain protection in previously immunized populations. This study examines the immune protection and safety of providing a one and two dose boosting regimen of Shanchol™ given five years after the initial dose.
Timeline
- Start
- 2012-12
- Primary completion
- 2013-07
- Completion
- 2013-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Shanchol | Vaccine | 1.5 ml | Oral |