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Trial - NCT04914832


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

marta nunes, PhD

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"}]