Study OEV-128 – Phase IIB Study in children 6-18 months in The Gambia
The objective of the planned study is to demonstrate if ETVAX®, given with two doses 14 days apart and a booster dose at day 90, is safe and provides protection against moderate-to-severe diarrhoea caused by ETEC. The study is a randomized, placebo-controlled, double-blind, field trial of the vaccine in approximately 5000 children residing in an ETEC-endemic area in The Gambia.
This study is co funded by the EU Research and Innovation Framework Program, Horizon 2020 through the European and Developing Countries Clinical Trials Partnership (EDCTP) organization.
Studies
- All studies
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Study OEV-128 – Phase IIB Study in children 6-18 months in The Gambia
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Study OEV-124 – Phase I, Age-descending study in Zambia
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Study OEV-123 – Phase IIb Safety, diagnostic methodology evaluation and estimated vaccine efficacy in travellers to Benin
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Study OEV-122 – Phase I/II, Age descending safety and immunogenicity trial in Bangladesh (age ≥6 mo)
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Study OEV-121A – Phase I, Booster dose memory study
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Study OEV-121 – Phase I, Safety and immunogenicity of vaccine
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Study OEV-120 – Phase I, Safety and immunogenicity of a prototype vaccine
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Study DMID 09-066 – Phase I, dmLT adjuvant safety and immunogenicity
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