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Trial - NCT05265065


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

None

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"}]