| Trial registration number
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EUCTR2021-002327-38-NL |
Full text link
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002327-38/NL
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First author
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Academic Medical Center - E. van Leeuwen
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Contact
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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onderzoeksbureauvkc@amsterdamumc.nl
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Registration date
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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2021-05-17
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Recruitment status
Last imported at : April 2, 2022, 4:28 p.m.
Source : EU Clinical Trials Register
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Terminated
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Study design
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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nonRCT
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Allocation
Last imported at : May 30, 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 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Parallel
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Masking
Last imported at : May 30, 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 30, 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 30, 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 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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- competent pregnant women (18 ≥ years)
- scheduled for COVID-19 vaccination
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Exclusion criteria
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- No written informed consent
- Age < 18 years
- No knowledge of Dutch or English language
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Number of arms
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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4
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Funding
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Academic Medical Center
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Inclusion age min
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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18
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Inclusion age max
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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100
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Countries
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Netherlands
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Type of patients
Last imported at : May 30, 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 30, 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 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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100
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primary outcome
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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The description of the antibody response in maternal blood during pregnancy and the amount of placental transfer as determined in umbilical cord blood in relation to the gestational age at vaccination.
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Notes
Last imported at : May 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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nan
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Phase
Last imported at : May 30, 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 30, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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[{"arm_notes": "Pregnant women;Dutch national vaccination program", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Dutch national vaccination program", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Dutch national vaccination program", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Dutch national vaccination program", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]
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