COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002088-23/BE

Sciensano - Pieter Pannus

Pieter.Pannus@sciensano.be

2021-04-20

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Employees of Mensura EDPB, 'carglass' or 'Havenbedrijf Antwerpen' and their family members The subject should be aged between 18 years and 55 years, having a Belgian National Number and be insured by a Belgian sickness fund. Received two COVID-19 vaccine doses (BNT162B2, Pfizer/BioNTech) at least five months before third dose administration In good general health as evidenced by medical history and/or physical examination Provided a signed and dated informed consent form Women of Childbearing Potential (WOCBP) will have a urine pregnancy test prior to vaccination

Employees (and their family members) not expected to continue working at Mensura EDPB, 'carglass' or 'Havenbedrijf Antwerpen' the following 12 months. pregnant and lactating women Subjects previously having received a third COVID-19 vaccine dose Subjects with a history of severe adverse reactions associated with a vaccine and/or severe allergic reaction to any component of the study intervention Individuals who are suffering from acute severe febrile illness or acute infection. People with a minor infection and/or low-grade fever should not be excluded

2

Sciensano

18

55

Belgium

Healthy volunteers

N/A

200

to assess the level of binding antibodies anti-RBD 28 days after third dose of SARS- CoV-2 vaccination

TODO

Phase 4

[{"arm_notes": "10 mcg", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 mcg", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]