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A Randomized Observer Blinded Controlled Non Inferiority Trial to Evaluate the Safety and Immunogenicity of Locally Manufactured Inactivated Bivalent Whole Cell-oral Cholera Vaccine (WC-OCV) 'Cholvax' in Bangladeshi Healthy Adults and Children
To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM, Investigators will conduct a clinical trial study Bangladeshi healthy adults and children. Cholvax is locally produced orally administered whole cell inactivated bivalent cholera vaccine. Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the oral cholera vaccine, Cholvax with technological support from International Vaccine Institute (IVI). Cholvax meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation. By this transfer of technology, it expected that the vaccine will become available for use in public health programs in Bangladesh and in the future in other cholera-affected countries in Asia and Africa to control endemic cholera, as well as to help control large-scale epidemics and outbreaks. Investigators will also evaluate and compare the safety and immunogenicity of 3 Cholvax lots (lot-to-lot consistency).
Details
| Lead sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 2052 |
| Start date | 2016-04 |
| Completion | 2017-06 |
Conditions
- Cholera
Interventions
- Cholvax
- Shanchol
Primary outcomes
- Number of participants with vaccine related reactogenicity as assessed by study personnel — Within 30 minutes after administration of vaccine
Number of reactogenecity events will be compared between test group and comparator group. - Number of participants with solicited adverse events as assessed by study personnel — Within 7 days after administration of vaccine
Number of solicited adverse events observed after each dose of vaccination assessed by study personnel through home visit and will be compared between test group and comparator group - Number of participants with unsolicited adverse event including serious adverse event as assessed by study physician — Within 6 months after administration of vaccine
Number of unsolicited adverse events including serious adverse event observed after each dose of vaccination assessed by study personnel through home visit and will be compared between test group and comparator group - Number of participants showing seroconversion against sero group V. cholerae O1 — 7 days after administration of vaccine
Proportion of participants showing sero-conversion against V. cholerae O1, upon vaccination Cholvax being tested in comparison with ShancholTM.
Countries
Bangladesh