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Column | Value |
---|---|
Trial registration number | NCT05265065 |
Full text link
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : Nov. 20, 2022, noon Source : ClinicalTrials.gov |
|
Contact
Last imported at : Nov. 20, 2022, noon Source : ClinicalTrials.gov |
None |
Registration date
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
2022-03-03 |
Recruitment status
Last imported at : Nov. 20, 2022, noon Source : ClinicalTrials.gov |
Not recruiting |
Study design
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
Blind label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
Prevention |
Inclusion criteria
Last imported at : June 8, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: have completed two doses of sinopharm, astrazeneca or sputnik vaccines with the recommended schedule 6 months prior to the date of enrolment willing and able to give written informed consent aged 18 years or above willing to complete the follow-up requirements of the study |
Exclusion criteria
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
received 3 doses of covid-19 vaccine received 2 doses of covid-19 less than 6 months prior to the start of the trial currently on immunosuppressive medication or anti-cancer chemotherapy hiv infection congenital immune deficiency syndrome has received immunoglobulin or other blood products in the 3 months prior to vaccination study staff and their relatives have a history of a severe allergic reaction to any covid-19 vaccines or have a medical exception to receiving further covid-19 vaccines |
Number of arms
Last imported at : June 8, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
6 |
Funding
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
Murdoch Childrens Research Institute |
Inclusion age min
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
Mongolia |
Type of patients
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
Severity scale
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
N/A |
Total sample size
Last imported at : Nov. 20, 2022, noon Source : ClinicalTrials.gov |
601 |
primary outcome
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
SARS-CoV-2 specific Immunoglobulin (Ig)G antibodies at 28-days post booster vaccination;Total incidence of solicited reactions (systemic and local) |
Notes
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
Phase 3 |
Arms
Last imported at : June 8, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Previously received two doses of AstraZeneca as primary COVID-19 vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Previously received two doses of AstraZeneca as primary COVID-19 vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Previously received two doses of Sinopharm as primary COVID-19 vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Previously received two doses of Sinopharm as primary COVID-19 vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Previously received two doses of Sputnik as primary COVID-19 vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Previously received two doses of Sputnik as primary COVID-19 vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |