69,329
Participants
Start Date
July 31, 2006
Primary Completion Date
December 31, 2011
Study Completion Date
May 31, 2013
bivalent killed whole cell oral cholera vaccine
"Given as 1.5 mL dose, given orally in 2 doses 14 days apart, each dose contains:~V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS"
Placebo
Heat Killed E. coli K12 in an optical turbidity identical to killed oral cholera vaccine, in 1.5 mL oral dose given twice, at least 14 days apart.
National Institute of Cholera and Enteric Diseases, Kolkata
National Institute of Cholera and Enteric Diseases, India
OTHER
Shantha Biotechnics Limited
INDUSTRY
International Vaccine Institute
OTHER