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COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine

NCT04852861 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2023-03-28

No results posted yet for this study

Summary

This is a randomized phase IV dose-optimization study evaluating the safety and immunogenicity of two doses of COVID-19 mRNA vaccines being authorized in the European Union since December 2020: Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in healthy adults up to age 55 year. Immunogenicity will be measured 28 days after first and second dose, and day 180 and day 365 after first vaccination of 20 and 30 mcg of BNT162b2. The primary outcome is the level of binding antibodies for RBD 28 days after the second dose.

Conditions

  • Covid19

Interventions

DIAGNOSTIC_TEST

immunogenicity after first and second dose

Humoral and cellulair immunity after first and second dose of the different vaccines administrated.

Sponsors & Collaborators

  • Mensura EDPB

    collaborator UNKNOWN

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Erasme University Hospital

    collaborator OTHER

  • Sciensano

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2021-07-31
Completion
2022-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04852861 on ClinicalTrials.gov