Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
3400 participants
INTERVENTIONAL
2020-07-15
2022-05-31
Brief Summary
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In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Intervention
Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19
oral polio vaccine + information
Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
Information
Advice regarding how to protect oneself from COVID-19
Control
Information regarding prevention of COVID-19
Information
Advice regarding how to protect oneself from COVID-19
Interventions
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oral polio vaccine + information
Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
Information
Advice regarding how to protect oneself from COVID-19
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
ALL
No
Sponsors
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Bandim Health Project
OTHER
Responsible Party
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Principal Investigators
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Ane Fisker, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Bandim Health Project
Locations
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Bandim Health Project
Bissau, , Guinea-Bissau
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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77/CNES/INASA/2020
Identifier Type: -
Identifier Source: org_study_id
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