Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine

PHASE2CompletedINTERVENTIONAL
Enrollment

2,052

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Cholera
Interventions
BIOLOGICAL

Cholvax

Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the OCV, Cholvax with technological support from International Vaccine Institute (IVI), which meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation.

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 vial.This vaccine is used as two dose regimen.

Trial Locations (1)

1212

International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka

All Listed Sponsors
collaborator

International Vaccine Institute

OTHER

lead

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

NCT02742558 - Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine | Biotech Hunter | Biotech Hunter