drugset

drugset / Trial / NCT00419133

Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

NCT00419133 ↗

Phase 2 Completed 160 enrolled International Vaccine Institute National Institute of Cholera and Enteric Diseases, India · collab Shantha Biotechnics Limited · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to compare the safety and immunogenicity of one and two doses of the killed oral cholera vaccine.

Timeline

Start: 2007-06
Primary completion: 2007-08
Completion: 2007-08

Publications

Results Kanungo S, Paisley A, Lopez AL, Bhattacharya M, Manna B, Kim DR, Han SH, Attridge S, Carbis R, Rao R, Holmgren J, Clemens JD, Sur D. Immune responses following one and two doses of the reformulated, bivalent, killed, whole-cell, oral cholera vaccine among adults and children in Kolkata, India: a randomized, placebo-controlled trial. Vaccine. 2009 Nov 16;27(49):6887-93. doi: 10.1016/j.vaccine.2009.09.008. Epub 2009 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Killed bivalent whole cell oral cholera vaccine	Vaccine	1.5 ml	Oral

Indications