| Trial registration number
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NCT05970887 |
Full text link
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05970887
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First author
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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None
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Contact
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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None
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Registration date
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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2023-08-01
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Recruitment status
Last imported at : March 27, 2024, 8 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
who agreed to receive both bivalent booster covid-19 vaccine and influenza vaccine
only individuals who had passed at least 3 months after the last confirmation of sars-cov-2 infection and/or the third dose of covid-19 vaccination
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Exclusion criteria
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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individuals with a contraindication to any of the vaccine compounds were excluded from the study
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Number of arms
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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3
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Funding
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Catholic Kwandong University
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Inclusion age min
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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65
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Countries
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Korea;Republic of
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Type of patients
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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154
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primary outcome
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups
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Notes
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Phase 4
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Arms
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 2644, "treatment_name": "Bnt162b2 ba.4/ba.5+quadrivalent influenza modrna vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "COVID-19 vaccine only", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "influenza vaccine only", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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