| Trial registration number
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EUCTR2021-003388-90-NL |
Full text link
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003388-90/NL
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First author
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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Princess Máxima Center for Pediatric Oncology - Prof. Dr. W.J.E. Tissing
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Contact
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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trialmanagement@prinsesmaximacentrum.nl
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Registration date
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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2021-06-21
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Recruitment status
Last imported at : July 6, 2021, noon
Source : EU Clinical Trials Register
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Recruiting
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Study design
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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nonRCT
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Allocation
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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Non-randomized
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Design
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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Parallel
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Masking
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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Open label
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Center
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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single-center
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Study aim
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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Prevention
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Inclusion criteria
Last imported at : July 31, 2021, 4:30 p.m.
Source : EU Clinical Trials Register
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-Willing to receive routine COVID-19 vaccination with Pfizer or Moderna vaccine as part of the national vaccination program (cohort I)
-Having received SARS-CoV-2 vaccination with Pfizer or Moderna as part of the national vaccination program with the last vaccination less than 4 weeks before study entry (cohort II)
-Written informed consent
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Exclusion criteria
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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-History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the study intervention
-Not able to give informed consent (e.g. language problems, illiteracy)
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Number of arms
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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2
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Funding
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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Princess Máxima Center for Pediatric Oncology
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Inclusion age min
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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12
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Inclusion age max
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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18
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Countries
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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Netherlands
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Type of patients
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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Healthy volunteers
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Severity scale
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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N/A
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Total sample size
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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130
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primary outcome
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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The primary study parameter is the antibody based immune response to vaccination 28 days (t=3) after the second vaccination compared to controls. Participants will be classified as responders or non-responders
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Notes
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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nan
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Phase
Last imported at : June 22, 2021, 2:30 a.m.
Source : EU Clinical Trials Register
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Phase 4
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Arms
Last imported at : June 22, 2021, 2:30 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"}, {"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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