drugset

drugset / Trial / NCT00119197

Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

NCT00119197 ↗

Phase 2 Completed 200 enrolled International Vaccine Institute Indian Council of Medical Research · collab National Institute of Cholera and Enteric Diseases, India · collab Shantha Biotechnics Limited · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.

Timeline

Start: 2005-08
Primary completion: 2006-06
Completion: 2006-07

Publications

Background Mahalanabis D, Lopez AL, Sur D, Deen J, Manna B, Kanungo S, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Rao R, Holmgren J, Clemens J, Bhattacharya SK. A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India. PLoS One. 2008 Jun 4;3(6):e2323. doi: 10.1371/journal.pone.0002323.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Shanchol	Vaccine	1.5 ml	Oral

Indications