Coronavirus SARS-CoV-2
Conditions
Interventions
The protocol will have two arms. Subjects will be randomised to receive either
1) BNT162b2 first dose followed by a second BNT162b2 dose (control arm), or 2)
a single dose of BNT162b2 vaccine (inter
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1.Aged >=5 years to
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The geometric mean ratio of neutralizing titers against wild type virus (Virus Neutralization Assay) at day 28 after completion of the control versus the intervention regimen of the vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: -The percentage of subjects reporting at least one solicited systemic adverse events Grade >= 2 (AEs) in the 7 days after any vaccine dose, as measure of systemic reactogenicity. -The percentage of subjects reporting solicited local and systemic adverse events (AEs) for 7 days after each vaccine dose. -The percentage of subjects reporting unsolicited AEs for 14 days after each vaccine dose. -The percentage of subjects reporting serious adverse events (SAEs) Grade >=3 on the Common Toxicity Criteria or Adverse Events of Special interest (AESI) until 12 months post-vaccination. Immunogenicity: -Neutralizing titers against wild type virus (Virus Neutralization Assay) at 6 and 12 months post-vaccination. -Quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA) at 28 days, 6 months and 12 months post-vaccination. -Geometric Mean Fold Ratio in SARS-CoV-2 serum anti-RBD antibody titer from before vaccination to each subsequent time points at 1, 6 and 12 months post-vaccination. -Neutralizing titers against variants of concern (Virus Neutralization Assay) at day 28 and 6 months post-vaccination. | — |
Countries
Netherlands
Outcome results
None listed