A Phase 2, Comparative Randomised Trial to Evaluate the impact ofreduced COVID-19 mRNA vaccination regimen on immunologicalresponses and reactogenicity in paediatric subjects withprior SARS-CoV-2 immunity - Immunogenicity and reactogenicity of reduced COVID-19 mRNA vaccination regimen in children (CoVacc)

niversity Medical Center Utrecht0 sites200 target enrollmentAugust 23, 2022

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

No summary available.

Registry

who.int

Start Date

August 23, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 Acceptable 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
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•1\. Has previously received any investigational or licensed COVID\-19 vaccine.
•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 have a significant
•effect on the target endpoints and which may therefore mask or inhibit the therapeutic
•effect under investigation as judged by the investigator.
•4\. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection or venepuncture.
•5\. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction