Status:
COMPLETED
Effectiveness of Covid-19 Vaccination in Eswatini Against SARS-CoV-2 Associated Hospitalization and Death
Lead Sponsor:
Shabir Madhi
Collaborating Sponsors:
AstraZeneca
Conditions:
COVID-19
Pneumonia, Viral
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Since late December 2019, the novel human coronavirus (SARS-CoV-2) first reported in China, has spread worldwide. Vaccines to prevent SARS-CoV-2 infections have been developed in record time and sever...
Detailed Description
This will be open-label, single-arm implementation study in Eswatini. All individuals who register on the National Vaccination Registry will be eligible for enrolment. Participants will receive appoin...
Eligibility Criteria
Inclusion
- Any individual aged 18 and older eligible to receive AZ1222 vaccine following the national immunization recommendations.
- Willing and able to provide informed consent.
Exclusion
- Any significant acute or chronic medical condition that in the opinion of the vaccinator makes the participant unsuitable for participation in the study or jeopardises the safety of the participant.
- Participant reports being pregnant.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
- Test negative vaccine effectiveness case-control study
- The study population consists of individuals presenting at the participating hospitals and health centres during the study period, who:
- Either
- Are hospitalized (or died) for an illness consistent with possible COVID-19. Or (in case of other hospital controls)
- Presented to the emergency department (ED) for reasons other than a COVID-19 like illness (e.g. trauma or elective surgery).
- And
- Meet the inclusion criteria.
- Inclusion criteria:
- Ever eligible to receive AZ1222 vaccine following the national immunization recommendations prior to hospital admission.
- And
- Willing and able to provide informed consent.
- Exclusion criteria:
- None
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
75012 Patients enrolled
Trial Details
Trial ID
NCT04914832
Start Date
August 30 2021
End Date
September 30 2022
Last Update
August 29 2023
Active Locations (1)
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1
Vaccination Center
Mbabane, Eswatini