EUCTR2021-005043-71-GR
Active, not recruiting
Phase 1
A Phase 2, Comparative Randomised Trial to Evaluate the impact of reduced COVID-19 mRNA vaccination regimens on immunological responses and reactogenicity in paediatric subjects with and without prior SARS-CoV-2 infection. - CoVacc
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy volunteers (paediatric subjects) with prior SARS-CoV-2 infection
- Sponsor
- niversity Medical Center Utrecht
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged \=5 years to \=11 years of age on day of signing the informed
- •consent form.
- •2\. In good health or stable clinical condition.
- •3\. Legally Accepted Representative (LAR) has reviewed the subject
- •information and signed the informed consent form on behalf of the
- •subject and the subject has expressed willingness to participate.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Has previously received any investigational or licensed COVID\-19
- •2\. Has known congenital or acquired immune disorder or
- •immunodeficiency that may interfere
- •with vaccine response e.g. known infection with human
- •immunodeficiency virus (HIV) with
- •low CD4 count or other immunosuppression at time of signing informed
- •consent form.
- •3\. Has a history of autoimmune disease or an active autoimmune disease
- •requiring therapeutic
- •intervention (including systemic glucocorticoids), or findings that may
Outcomes
Primary Outcomes
Not specified
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Recruiting
Phase 2
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