Moderna begins phase 2/3 trial to test COVID-19 vaccine in children
Moderna announced that it started a phase 2/3 trial for its messenger RNA COVID-19 vaccine in children aged 6 months to 12 years.
The study, dubbed KidCOVE, is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority (BARDA). Investigators have completed enrollment of 6,750 healthy children.
“We are pleased to begin this phase 2/3 study of mRNA-1273 in healthy children in the U.S. and Canada and we thank NIAID and BARDA for their collaboration,” Moderna CEO Stéphane Bancel said in a statement. “We are encouraged by the primary analysis of the phase 3 COVE study of mRNA-1273 in adults ages 18 and above, and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population.”
The phase 2/3 trial is separated into two parts — the first is an open-label, dose-escalation, age de-escalation phase, followed by a randomized, observer-blind, placebo-controlled expansion. Both will examine the safety, tolerability, reactogenicity and effectiveness of the two-dose vaccine, which will be given 28 days apart.
In the first part of the trial, participants aged 2 to 12 years will receive the first dose of the mRNA vaccine at 50 µg or 100 µg. Those aged between 6 months and 2 years will receive the first of three doses at either 25 µg, 50 µg or 100 µg. Following the administration, an interim analysis will assess which dose is given in the second part of the trial.
Following the administration of the second dose of the vaccine, all participants will be followed for 12 months. Effectiveness will be determined through either achieving a correlate of protection, or through “immunobridging” the population aged 18 to 25 years, according to Moderna.