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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 |
|
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"}] |