Trial intelligence / Profile preview

Safety and Immunogenicity of Bivalent BNT162b2 in Healthy Infants

NCT05630352Phase 1Withdrawn

Sponsor
BioNTech SE
Start
Jan 2025
Primary completion
Jul 2026
Modality
Vaccines & Immunotherapeutics, Lipid-based Nanoparticles, mRNA Therapeutics
01

Overview

Phase 1, randomised, open-label trial of Comirnaty Bivalent Original/Omicron BA.4/BA.5 in coronavirus disease 2019 (COVID-19) (4 arms), sponsored by BioNTech SE. Primary endpoints: Percentage of participants reporting local reactions, Percentage of participants reporting systemic events and 2 more. Planned start Jan 2025; status: withdrawn.

02

Drugs

Comirnaty Bivalent Original/Omicron BA.4/BA.5
03

Conditions

coronavirus disease 2019 (COVID-19)

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