Trial Profile

A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN

Status: Completed

Phase of Trial: Phase II/III

Latest Information Update: 23 Sep 2024

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At a glance

20 Sep 2024 According to a Pfizer media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY KP.2) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
18 Dec 2023 Status changed from active, no longer recruiting to completed.
07 Nov 2023 Planned End Date changed from 11 Oct 2023 to 22 Nov 2023.

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