Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

PHASE2CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

June 30, 2006

Study Completion Date

July 31, 2006

Conditions
Cholera
Interventions
BIOLOGICAL

killed whole cell oral cholera vaccine

"Bivalent oral killed cholera vaccine: each dose of this vaccine contains:~* Inactivated V.Cholerae Inaba (569B), Classical biotype - 25.109 cells~* Inactivated V.Cholerae Ogawa (Cairo 50) Classical biotype - 25.109 cells~* Inactivated V.Cholerae Inaba (Phil 6973) El Tor biotype - 50.109 cells~* Inactivated V.Cholerae O139 - 50.109 cells~each 1.5 mL dose given orally, two doses given 14 days apart"

BIOLOGICAL

Heat Killed E. coli

"Escherichia coli K12 strain placebo: each dose of placebo contains heat-killed E. coli K12 strain in an amount whose optical turbidity is identical to that for the cholera vaccine.~Each 1.5 mL dose given orally, two doses given 14 days apart"

Trial Locations (1)

Unknown

National Institute of Cholera and Enteric Diseases, Kolkata

All Listed Sponsors
collaborator

National Institute of Cholera and Enteric Diseases, India

OTHER

collaborator

Indian Council of Medical Research

OTHER_GOV

collaborator

Shantha Biotechnics Limited

INDUSTRY

lead

International Vaccine Institute

OTHER

NCT00119197 - Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata | Biotech Hunter | Biotech Hunter