COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005043-71/NO

University Medical Center Utrecht - EUPG, CoVacc Study Team

covacc@umcutrecht.nl

2022-02-10

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

1. 5 up to and including 11 years of age on day of signing the informed consent form. 2. In good health or stable clinical condition. 3. Has documented evidence of a previous SARS-CoV-2 infection or presence of SARS-CoV-2 specific serum antibodies. 4. Legally Accepted Representative (LAR) has reviewed the subject information and signed the informed consent form on behalf of the subject.

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. 10. Is unable to report solicited adverse events.

2

University Medical Center Utrecht

2

12

Netherlands

Healthy volunteers

N/A

80

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.

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": "once-off", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2 doses", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]