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 with prior SARS-CoV-2 immunity
- Conditions
- CoronavirusSARS-CoV-210047438
- Registration Number
- NL-OMON54453
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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.
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 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 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The geometric mean ratio of neutralizing titers against wild type virus (Virus<br /><br>Neutralization Assay) at day 28 after completion of the control versus the<br /><br>intervention regimen of the vaccine.</p><br>
- Secondary Outcome Measures
Name Time Method