| Trial registration number
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EUCTR2021-002030-16-AT |
Full text link
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002030-16/AT
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First author
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Medizinische Universität Innsbruck, Institut für Virologie - Principal Investigator
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Contact
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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wegena.borena@i-med.ac.at
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Registration date
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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2021-04-29
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Recruitment status
Last imported at : May 9, 2022, 5 p.m.
Source : EU Clinical Trials Register
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Completed
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Study design
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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nonRCT
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Allocation
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Non-randomized
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Design
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Adaptive
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Masking
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Open label
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Center
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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single-center
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Study aim
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Prevention
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Inclusion criteria
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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1. Participant is ≥ 18 years of age on the day of signing the ICF and provides written informed consent
or
participant is between 16 and 18 years of age and provides informed consent as well as his/her legal representative/custodial
2. Subject has been already vaccinated with Comirnaty (two doses), with the second dose having been administered within up to 6 weeks (35 days ± 7 days) before study inclusion
3. Subject understands and agrees to comply with study procedures
4. Subject must be willing to be contacted by telephone or willing to complete an eDiary during study participation
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Exclusion criteria
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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1. Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to either prevent or treat COVID-19
2. Participant has a contraindication to blood draws (eg, bleeding disorders)
3. Has participated in an interventional clinical study within 30 days prior to study inclusion
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Number of arms
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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1
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Funding
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Medizinische Universität Innsbruck, Institut für Virologie
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Inclusion age min
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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12
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Inclusion age max
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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100
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Countries
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Austria
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Type of patients
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Healthy volunteers
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Severity scale
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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N/A
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Total sample size
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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3340
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primary outcome
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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The level of neutralizing titers at visit 1
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Notes
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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TODO
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Phase
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Phase 4
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Arms
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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