Immunogenicity and reactogenicity of reduced COVID-19 vaccination regimen in children (CoVacc).

Phase 1

• Conditions: Healthy 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]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-16
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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
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, in case of such
medications receiving
approval in this age group during the trial.
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
subject 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 sponsor or 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.

Study & Design

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