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Trial - NCT05279456


Column Value
Trial registration number NCT05279456
Full text link
Last imported at : March 18, 2022, 1 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : Aug. 19, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

Sharen Pringle, Grad Cert

Contact
Last imported at : Aug. 19, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

sharen.pringle@arasmi.com

Registration date
Last imported at : March 18, 2022, 1 a.m.
Source : ClinicalTrials.gov

2022-03-15

Recruitment status
Last imported at : Aug. 19, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 18, 2022, 1 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 : March 18, 2022, 1 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

inclusion criteria: able to provide written informed consent males or females* 18 years of age or older understand and are likely to comply with planned study procedures and be available for all study visits. have not previously had a covid-19 vaccine and do not intend to have a non-study covid-19 vaccine within the next 6 months

Exclusion criteria
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

history of covid-19 vaccination. history of serious vaccine allergy. pregnancy1 have received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial reporting period. any medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.

Number of arms
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

2

Funding
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

Vaxine Pty Ltd

Inclusion age min
Last imported at : March 18, 2022, 1 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 18, 2022, 1 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : March 18, 2022, 1 a.m.
Source : ClinicalTrials.gov

Australia

Type of patients
Last imported at : March 18, 2022, 1 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : March 18, 2022, 1 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

400

primary outcome
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

Final GMT;Final Seroconversion;First Dose Adverse events (AE);First Dose GMT;First dose Seroconversion;Second Dose Adverse events (AE);Second Dose GMT;Second dose Seroconversion;Serious adverse events (SAE);Third Dose Adverse events (AE);Third Dose GMT;Third Dose Seroconversion

Notes
Last imported at : March 18, 2022, 1 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : July 7, 2022, midnight
Source : ClinicalTrials.gov

[{"arm_notes": "accelerated arm", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "standard arm", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]