Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

840

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

November 30, 2017

Study Completion Date

November 30, 2017

Conditions
Cholera
Interventions
BIOLOGICAL

HL-OCV

Pharmaceutical company in Bangladesh is now producing HL-OCV, with technological support from MSD wellcome trust Hilleman pt. ltd, which meets international Good manufacturing practice( GMP) standards and WHO production guidelines.

BIOLOGICAL

Shanchol

The vaccine is manufactured by Shantha Biotechnics in hyderabad, India and is prequalified by the WHO. Shanchol is available in a single dose. This vaccine is used as two dose regimen.

Trial Locations (1)

1212

International Centre for Diarrhoeal disease Research,Bangladesh, Dhaka

All Listed Sponsors
collaborator

MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.

INDUSTRY

lead

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

NCT02823899 - Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine | Biotech Hunter | Biotech Hunter