Clinical Study Evaluating the immune responses and safety of lower dose COVID-19 mRNA Vaccination in children (CoVacc)

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]; Healthy volunteers (paediatric subjects) with or without prior SARS-CoV-2 infection; MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865

• Registration Number: EUCTR2021-005043-71-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-09
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. 12 or 13 years of age on day of signing the informed consent form.
2. In good health or stable clinical condition.
3. Has reviewed the subject information and signed the informed consent form.
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
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.
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 is
employed by the sponsor or principal investigator.
10. Is unable to report solicited adverse events.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified