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Column | Value |
---|---|
Trial registration number | NCT04914832 |
Full text link
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
marta.nunes@wits-vida.org |
Registration date
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
2021-06-07 |
Recruitment status
Last imported at : June 8, 2023, noon Source : ClinicalTrials.gov |
Unknown |
Study design
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
nonRCT |
Allocation
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
Non-randomized |
Design
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
Single group assignment |
Masking
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
Prevention |
Inclusion criteria
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - any individual aged 18 and older eligible to receive az1222 vaccine following the national immunization recommendations. - willing and able to provide informed consent. |
Exclusion criteria
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
- 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. |
Number of arms
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
1 |
Funding
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
Shabir Madhi |
Inclusion age min
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
Swaziland |
Type of patients
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
Severity scale
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
N/A |
Total sample size
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
600 |
primary outcome
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
To estimate the AZD1222 vaccine effectiveness;Vaccine effectiveness in HIV-uninfected |
Notes
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
Phase 4 |
Arms
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "2;weeks1-10", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |