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Trial - NCT05148871


Column Value
Trial registration number NCT05148871
Full text link
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05148871

First author
Last imported at : May 20, 2022, 9 a.m.
Source : ClinicalTrials.gov

Dimitar Sajkov

Contact
Last imported at : May 20, 2022, 9 a.m.
Source : ClinicalTrials.gov

not reported

Registration date
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

2021-12-08

Recruitment status
Last imported at : May 20, 2022, 9 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 10, 2021, 12:30 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 : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

inclusion criteria: provide written informed consent prior to initiation of any study procedures. no history of previous covid-19 vaccinations women of childbearing potential must use an acceptable contraception method from at least 28 days before study vaccination until 14 days after last study vaccination. understand and comply with planned study procedures and be available for all study visits.

Exclusion criteria
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

have a history of severe systemic reactions (anaphylaxis, breathing difficulties, severe rash) following previous immunization with licensed or unlicensed vaccines. received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period. intend to receive another covid-19 vaccine during the time of the study

Number of arms
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

Vaxine Pty Ltd

Inclusion age min
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Australia

Type of patients
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

SARS-CoV-2 protection;Spike antibody immunogenicity;Spike antibody seroconversion

Notes
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "2, 3 weeks apart", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2, 4 weeks apart", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2, 5 weeks apart", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2, 6 weeks apart", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]