| Trial registration number
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EUCTR2022-002560-73-NL |
Full text link
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002560-73/NL
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First author
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Erasmus MC - Hugo van der Kuy
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Contact
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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h.vanderkuy@erasmusmc.nl
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Registration date
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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2022-07-14
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Recruitment status
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Recruiting
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Study design
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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RCT
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Allocation
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Randomized
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Design
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Parallel
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Masking
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Open label
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Center
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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multi-center
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Study aim
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Prevention
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Inclusion criteria
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Participants will be recruited from both the SWITCH-trial (Janssen primed HCWs)(1-3) and the Erasmus MC HCW-study (mRNA primed HCWs)(4, 5), as these participants are well characterized and documented in earlier responses to COVID-19 vaccinations. Participants may participate regardless of a previous SARS-CoV-2 infection. By randomizing over the different groups, we assume that the experienced infections are equally distributed over the groups. To assess whether this was truly the case, N-specific antibodies will be retrospectively measured in the pre boost sample from all participants.
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Exclusion criteria
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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1. HCW younger than 18
2. HCW that are pregnant or have a wish to become pregnant within 6 months
3. All regular contra-indications of the vaccines will be applied
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Number of arms
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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2
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Funding
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Erasmus MC
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Inclusion age min
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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18
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Inclusion age max
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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65
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Countries
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Netherlands
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Type of patients
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Health workers
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Severity scale
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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N/A
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Total sample size
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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400
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primary outcome
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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1.Level of antibodies and T-cell responses
2. PRNT against relevant variants in a random selection of study participants.
3. Adverse events (AE)
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Notes
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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TODO
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Phase
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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Phase 4
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Arms
Last imported at : Sept. 3, 2022, 7:30 a.m.
Source : EU Clinical Trials Register
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[{"arm_notes": null, "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": null, "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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