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| Column | Value |
|---|---|
| Trial registration number | NCT05542862 |
|
Full text link
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
office@arasmi.org |
|
Registration date
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
2022-09-16 |
|
Recruitment status
Last imported at : Oct. 17, 2022, 12:34 p.m. Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
nonRCT |
|
Allocation
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Single group assignment |
|
Masking
Last imported at : Sept. 18, 2022, 3 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 : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
inclusion criteria: able to provide written informed consent males or females 18 years of age or older have previously had a primary course of covid-19 vaccine with the most recent dose no less than 3 months previously. understand and are likely to comply with planned study procedures and be available for all study visits. exclusion criteria allergy to spikogen vaccine or one of its components, e.g. polysorbate 80. 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 serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study. |
|
Exclusion criteria
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
None |
|
Number of arms
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
1 |
|
Funding
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Vaxine Pty Ltd |
|
Inclusion age min
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Australia |
|
Type of patients
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
150 |
|
primary outcome
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Antibody durability;Geometric mean titer fold change;Safety assessment 1;Safety assessment 2;SARS-CoV-2 infection;Seroconversion;Seroconversion in participants with and without evidence of past infection;Seroprotection;Seroprotection in participants with and without evidence of past infection;Spike antibody GMT in participants with and without evidence of past infection |
|
Notes
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |