Oral Cholera Vaccine Delivery in Rural Bangladesh

NACompletedINTERVENTIONAL
Enrollment

60,000

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Cholera
Interventions
BIOLOGICAL

Shanchol vaccine

Shanchol vaccine contains whole cell inactivated heat killed and formalin killed bacteria consisting of 600 ELISA Units (EU) of lipopolysaccharide (LPS). It consists of formalin-killed V. cholerae Inaba, El Tor biotype (strain Phil 6973). It also contains 300 EU LPS of heat-killed V. cholerae Ogawa classical biotype (Cairo 50); 300 EU LPS of formalin killed V. cholerae Ogawa classical biotype (Cairo 50); 300 EU LPS of heat-killed V. cholerae Inaba, classical biotype (Cairo 48); and 600 EU LPS of formalin killed V. cholerae O139 (4260B) (9). The vaccine has no detectable cholera toxin. Vaccine is packaged as liquid formulations in 1.5-ml doses. No buffer is needed for administered.This vaccine is licensed in India and WHO prequalified.

Trial Locations (1)

1212

International Centre for Diarrhoeal Disease Research,Bangladesh, Dhaka

All Listed Sponsors
collaborator

Government of Bangladesh

OTHER_GOV

lead

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

NCT01811771 - Oral Cholera Vaccine Delivery in Rural Bangladesh | Biotech Hunter | Biotech Hunter