Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh

"We will use the killed whole cell oral cholera vaccine, Shanchol that will be manufactured by Shantha Biotechnics, in Hyderabad, India for the study. The vaccine is registered in India and is prequalified by the WHO. Shanchol is available in a single dose vial. Vaccine will be maintained at 2-8oC. Each participant over the age of one year and non pregnant females living in communities will be individually randomized to receive vaccine.Pregnancy status will be enquired verbally for all married women of child bearing age during the census update as well as before vaccination to exclude them from the study.~Prior to vaccination, informed consent will be taken from the adults and guardians of minor participants .Each dose of vaccine will be 1.5 ml in volume."

Placebo will be transported from the manufacturer and will be maintained at 2-8oC. Each participant over the age of one year and non pregnant females living in communities will be individually randomized to receive placebo.Each dose of placebo will be 1.5 ml in volume.Placebo will be dispensed in liquid form in identical vials.