Trial no.:
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PACTR202011804563392 |
Date of Approval:
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26/11/2020 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA)
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Official scientific title |
A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) |
Brief summary describing the background
and objectives of the trial
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Typhoid fever remains a significant health problem in sub Saharan Africa with incidence rates > 100 cases per 100,000 person years of observation despite available typhoid conjugate vaccines (TCV). No cluster-randomized trial has been conducted on the African continent to our knowledge informing on TCV population-level protection data. A cluster-randomized controlled phase IV trial will assess the impact of a Vi-Polysaccharide conjugated Tetanus toxoid vaccine in the population of intervention clusters compared with the population in control clusters that are receiving a meningococcal A conjugate vaccine. |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
TyVEGHA |
Disease(s) or condition(s) being studied |
Infections and Infestations |
Sub-Disease(s) or condition(s) being studied |
Typhoid fever |
Purpose of the trial |
Prevention: Vaccines |
Anticipated trial start date |
01/03/2021 |
Actual trial start date |
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Anticipated date of last follow up |
31/01/2024 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
23000 |
Actual target sample size (number of participants) |
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Recruitment status |
Active, not recruiting |
Publication URL |
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