Clinical Study Evaluating the immune responses and safety of single versus two dose COVID-19 mRNA Vaccination in children (CoVacc)
- Conditions
- Healthy volunteers (paediatric subjects) with prior SARS-CoV-2 infectionMedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-005043-71-SE
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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
(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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method