NCT05715944

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,888 (actual)
• Sponsor: Botswana Harvard AIDS Institute Partnership · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	AZD 1222	Vaccine

Timeline

• Start date: 2021-09-15
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2023-02-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: Botswana