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Incidence of COVID-19 Following Vaccination in Botswana Against SARS CoV 2

COVID-19 Clinical Trial

Official title:
Open-Label, Single-Arm, Phase 3b Study of the Incidence of Severe COVID-19 and Adverse Events Following AZD1222 COVID-19 Vaccination in Botswana Against SARS-CoV-2, AZD1222 - ESR-21-21311

Clinical Trial Summary

The AstraZeneca Study is a single-arm, open-label, interventional, Phase 3b study to determine the incidence of laboratory-confirmed COVID-19 hospitalizations, disease severity, and deaths and attributable adverse events (AEs) in participants in Botswana given 1 to 2 injections of AZD1222 eight to twelve weeks apart as primary series and/or 1 injection as booster dose. Length of follow-up will be 6 to 12 months, depending upon at which dose a participant is enrolled.

Clinical Trial Description

The AstraZeneca Study is an Open-Label, Single-Arm, Phase 3b Study of the incidence of severe COVID-19 and adverse events following AZD1222 COVID-19 vaccination in Botswana against SARS-CoV-2. The study enrolled adult participants >18 years (previously >40 years) in Botswana and vaccinate them with 1 to 2 doses of AZD 1222, as primary series and/or 1 dose as booster. Primary Objectives: 1. To assess the occurrence of severe COVID-19 disease among individuals vaccinated with AZD1222 by number of vaccine doses. 2. To assess AEs among individuals vaccinated with at least one dose of AZD1222. Secondary Objectives: 1. To assess the occurrence of COVID-19 disease among individuals vaccinated with AZD1222 by number of vaccine doses by age group, co-morbidity group, the severity of disease and the time since the last dose. 2. To estimate the incidence of symptomatic SARS-CoV-2 infections in a sub-cohort of study participants among individuals vaccinated with at least one dose of AZD1222 by number of vaccine doses ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05715944
Study type Interventional
Source Botswana Harvard AIDS Institute Partnership
Contact
Status Completed
Phase Phase 3
Start date September 15, 2021
Completion date December 30, 2022
View Details
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