NL-OMON54387
Recruiting
Phase 4
Prospective monitoring of antibody response following COVID-19 vaccination in patients with Down syndrome - PRIDE
niversitair Medisch Centrum Utrecht0 sites640 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 640
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. All patients have opted to receive routine COVID\-19 vaccination.
- •2\. Age: \>\=16 years or \<16 years if vaccine is recommended for routine use for
- •that age group
- •3\. Either Down syndrome or healthy household contact
- •\- All participants who participated in part 1 of the study and who have opted
- •to receive a third SARS\-CoV\-2 vaccination by the studyteam or the Dutch
- •government.
- •Additional Durability time point: All individuals already participating in the
- •PRIDE study are eligble to participate in this additional time point
Exclusion Criteria
- •Down syndrome cohort: History of severe adverse reaction associated with a
- •vaccine and/or severe allergic reaction (eg, 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 care for
- •inherited or acquired immune deficiency, any moderate to severe comorbidity for
- •which regular medical care is needed (pe heart failure, COPD, diabetes).
Outcomes
Primary Outcomes
Not specified
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