A study to evaluate Moderna’s COVID-19 vaccine, mRNA-1273, in pediatric patients has been initiated in the United States and Canada.
The KidCOVE Phase 2/3 study (ClinicalTrials.gov: NCT04796896) is evaluating the safety and effectiveness of the vaccine in healthy children aged 6 months to less than 12 years. The two-part study consists of an open dose finding part (part 1) and a randomized, observer-blind, placebo-controlled expansion study (part 2).
In Part 1 of the study, participants aged 2 to less than 12 years of age can receive either a 50 mcg or 100 mcg dose (the 100 mcg dose is currently approved for use in adults under emergency approval) for 6 months to less than 2 years this can receive 1 of 3 doses: 25 μg, 50 μg or 100 μg. A dose for each age group is selected and used in Part 2 of the study, with participants being monitored for 12 months after the second vaccination.
The primary outcome of the study is the vaccine’s efficacy, which the company claims will be derived either by achieving a protective correlate or by immunobridging for the young adult population (18-25 years old). Safety and reactogenicity are also assessed.
“We are encouraged by the primary analysis of the Phase 3 COVE study with mRNA-1273 in adults aged 18 and over. This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age group, “said Stéphane Bancel, Chairman of the Board of Moderna.
More information about the trial, including eligibility criteria, can be found here.
Moderna announces first participants treated in phase 2/3 of the COVID-19 vaccine candidate in the pediatric population. [press release]. Cambridge, MA: Moderna Inc .; March 16, 2021.
This article originally appeared on MPR
COVID19 General Neurology Pediatric Neurology