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Trial - EUCTR2021-002613-34-NL


Column Value
Trial registration number EUCTR2021-002613-34-NL
Full text link
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002613-34/NL

First author
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

University Medical Center Utrecht - PRIDE study

Contact
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

pride-onderzoek@umcutrecht.nl

Registration date
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

2021-06-11

Recruitment status
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

Recruiting

Study design
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

nonRCT

Allocation
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

Non-randomized

Design
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

Prevention

Inclusion criteria
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

Subjects are eligible for the study if all of the following apply: Willing to receive routine COVID-19 vaccination with Pfizer, Moderna or AstraZeneca vaccine. Age: ≥16 years or <16 years once vaccine is recommended for routine use in this age group Either Down syndrome or household contacts without Down syndrome of participant with Down syndrome

Exclusion criteria
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

A potential subject who meets any of the following criteria will be excluded from participation in this study: Down syndrome cohort History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s). Organ transplant recipients Active malignancy or completion of treatment for malignancy in previous 3 months Infection with Human Immunodeficiency Virus (HIV) Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. Healthy control cohort As in Down Syndrome cohort Plus Active medical care for inherited or acquired immune deficiency Any severe comorbidity for which regular medical care is needed (e.g. heart failure, COPD, diabetes)

Number of arms
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

3

Funding
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

University Medical Center Utrecht

Inclusion age min
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

0

Inclusion age max
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

Netherlands

Type of patients
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

High risk patients

Severity scale
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

640

primary outcome
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

The primary study parameter is the antibody based immune response to vaccination against COVID-19 28 days after the second vaccination as compared to controls.

Notes
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

nan

Phase
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : July 1, 2021, 7 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "2", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]