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Phase III Study of Hillchol vs Shanchol in Cholera
NCT05507229Phase 3
Key facts
- Status
- Unknown
- Start
- Feb 2022
- Primary completion
- Jul 2022
- Countries
- 1
- Sponsor
- Bharat Biotech
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- Hillchol
- Conditions
- cholera
01
Overview
Phase 3, randomised, double-blind trial of Hillchol in cholera (4 arms), sponsored by Bharat Biotech. Primary endpoints: Proportion of participants achieving seroconversion against Ogawa serotype at Day 28 and Proportion of participants achieving seroconversion against Inaba serotype at Day 28. Status: unknown.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Hillchol Lot-I
Hillchol (BBV131) Lot-I administered on Day 0 and 14
Hillchol Lot-II
Hillchol (BBV131) Lot-II administered on Day 0 and 14
Hillchol Lot-III
Hillchol (BBV131) Lot-III administered on Day 0 and 14
Shanchol
Shanchol vaccine administered on Day 0 and 14
03
Who it enrols
Healthy participants aged >1 year without history of cholera or cholera vaccination, severe chronic diseases, or immune disorders.
04
Endpoints
Primary
Proportion of participants achieving seroconversion against Ogawa serotype
Proportion of participants achieving seroconversion against Inaba serotype
Secondary
Geometric Mean Titers of anti-Ogawa antibodies
Geometric Mean Titers of anti-Inaba antibodies
Immediate reaction
Incidence of solicited adverse events
Incidence of unsolicited adverse events
Incidence of all adverse events and Serious Adverse Events
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