Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine
Cholera
About this trial
This is an interventional prevention trial for Cholera focused on measuring cholera vaccine, randomized trial, immunogenicity
Eligibility Criteria
Inclusion Criteria:
- Age: 1-45 Years.
- Informed consent from study participants and guardian in case of children (1-17 years) and assent from children aged 11-17 years.
- Participation in the study at least for next 6 months
- Considered healthy as per medical judgment of the investigator
Exclusion Criteria:
- Suffering from diarrhea or abdominal pain or vomiting in the past 24 hours or diarrhea lasting for more than 2 weeks in the past 6 months
- History of taking oral cholera vaccine and history of confirmed cholera.
- History of taking any other live or killed enteric vaccine in the last 8 weeks.
- History of anaphylaxis or serious vaccine reaction.
- Currently use of any immunosuppressive or immune-modifying drugs. 6.100.4 0 F (38℃) or higher body temperature measured prior to investigational product dosing.
7.Receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months.
8.Currently on antimicrobial therapy. 9.Severe malnutrition or chornic disease based on the jugement of the investigator.
10.Stool sample at screening positive for V. cholerae. 11.Pregnant women or plans to become pregnant during the study period .
Sites / Locations
- International Centre for Diarrhoeal Disease Research, Bangladesh
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
cholvax
shanchol
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.
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.