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AZD1222 COVID-19 Vaccination in Eswatini
NCT04914832Phase 4
Key facts
- Status
- Completed
- Start
- Aug 2021
- Primary completion
- Sep 2022
- Countries
- 1
- Modality
- Viral Vector Vaccines
- Drugs
- ChAdOx1 nCoV-19
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 4, open-label, single-arm trial of ChAdOx1 nCoV-19 in coronavirus disease 2019 (COVID-19). Primary endpoints: Number of HIV-uninfected patients with laboratory-confirmed SARS-CoV-2 illness at 1 year and Number of patients with laboratory-confirmed SARS-CoV-2 illness who have been vaccinated with at least one dose at 1 year. Started Aug 2021; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
AZD1222 Implementation Arm
All individuals who register on the National Vaccination Registry receive two doses of AZD1222 10 weeks apart.
03
Who it enrols
Individuals aged 18 and older eligible for AZD1222 vaccination per national recommendations, excluding pregnant women and those with severe allergic reactions to vaccine components.
04
Endpoints
Primary
Number of HIV-uninfected patients with laboratory-confirmed SARS-CoV-2 illness
Number of patients with laboratory-confirmed SARS-CoV-2 illness who have been vaccinated with at least one dose
Secondary
Number of patients with laboratory-confirmed SARS-CoV-2 illness who have been fully vaccinated
Number of patients with laboratory-confirmed SARS-CoV-2 illness according to vaccination interval between doses
Number of patients with laboratory-confirmed SARS-CoV-2 illness by genetic variant
Number of patients of special interest with laboratory-confirmed SARS-CoV-2 illness
Number of patients with laboratory-confirmed SARS-CoV-2 illness by time since vaccination
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