A Phase 2, Comparative Randomised Trial to Evaluate the impact of reduced COVID-19 mRNA vaccination regimen on immunological responses 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 enrollmentJuly 7, 2022

ConditionsHealthy volunteers (paediatric subjects) with prior SARS-CoV-2 infection MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865 Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsComirnaty original Comirnaty Original/Omicron BA.4-5

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 Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 7, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Medical Center Utrecht

Eligibility Criteria

Inclusion Criteria

•1\.Aged \= 5 years to \= 11 years old 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
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•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 (eg, anaphylaxis) to any component of the study intervention(s).
•6\. Receipt of medications intended to prevent COVID\-19\.
•7\. Uses drugs with significant interaction with the investigational product or has any contraindications as per the Summary of Product Characteristics.
•8\. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
•9\. Has any kind of dependency on the principal investigator or member of the study team or LAR is employed by the principal investigator or within the same department as the PI or study team at the institution where the study is executed.
•10\. Is unable to report solicited adverse events.