COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-004889-35/NO

University College Dublin - Department of Infectious Diseases

paddy.mallon@ucd.ie

2022-04-06

Recruiting

RCT

Randomized

Adaptive

Open label

multi-center

Prevention

Adults aged 18 years or above at baseline Be at least three but no more than 6 months (+/- 4 weeks) from the date of 3rd dose of BNT162b2 vaccine at the time of consent Have received three homologous doses as primary vaccination against SARS-CoV-2 with BNT162b2 vaccine (vaccination status should be documented). Written informed consent from the subject has been obtained.

Unable to provide written, informed consent Participation in any other interventional trials People who have already received a booster vaccination Any significant or uncontrolled disease posing a risk with vaccination as judged by the investigator Any significant medical condition that in the opinion of the investigator would necessitate booster vaccination against SARS-CoV-2 within the trial timelines Any kind of dependency on the sponsor or principal investigator or employed by the sponsor or principal investigator Where a subject’s primary vaccination and third dose vaccination was not with the BNT162b2 mRNA vaccine Any contraindication to the vaccines in the trial as per the Summary of Medicinal Product Characteristics, SmPC) or the Investigator’s Brochure, if appropriate. Use of drugs with significant interaction with the investigational product Subjects who are pregnant and who are planning to become pregnant Nursing mothers Unwillingness to use highly effective contraceptive methods.

4

University College Dublin

18

100

Belgium;Denmark;Germany;Ireland;Netherlands;Norway;Spain;Sweden;Switzerland

Healthy volunteers

N/A

40

The primary endpoint comprises a composite endpoint of either an increase in anti-RBD antibody titre to ≥500 IU/mL at day 14 post 4th dose booster vaccine in those with anti-RBD antibody titre of ≤500 IU/mL immediately before 4th dose booster vaccination or a 2-fold increase in anti-RBD antibody titre at day 14 following 4th dose vaccination in those with anti-RBD titre of ≥500 IU/mL immediately before 4th dose booster vaccination, as measured by quantitative immunoassay targeting the anti-RBD antibody.

Declared number of arm (4.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": "various times for 4th vaccine dose", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "various times for 4th vaccine dose", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "various times for 4th vaccine dose", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\t\nControl group offered 3rd dose vaccine at the end of the study(19 months after initial vaccination)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]