drugset

drugset / Trial / NCT01524640

Bridging Study for Killed Oral Cholera Vaccine in Ethiopia

NCT01524640 ↗

Phase 4 Completed 216 enrolled International Vaccine Institute Armauer Hansen Research Institute, Ethiopia · collab Ministry of Health, Ethiopia · collab Shantha Biotechnics Limited · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.

Timeline

Start: 2012-12
Primary completion: 2013-08
Completion: 2013-08

Publications

Desai SN, Akalu Z, Teshome S, Teferi M, Yamuah L, Kim DR, Yang JS, Hussein J, Park JY, Jang MS, Mesganaw C, Taye H, Beyene D, Bedru A, Singh AP, Wierzba TF, Aseffa A. A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia. Am J Trop Med Hyg. 2015 Sep;93(3):527-533. doi: 10.4269/ajtmh.14-0683. Epub 2015 Jun 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Killed Bivalent (O1 and O139) whole cell oral cholera vaccine	Vaccine	1.5 ml	Oral

Indications