A study assessing Moderna’s COVID-19 vaccine, mRNA-1273, in pediatric patients has been initiated in the United States and Canada.
The phase 2/3 KidCOVE study (ClinicalTrials.gov: NCT04796896) is evaluating the safety and effectiveness of the vaccine in healthy children between 6 months and less than 12 years of age. The two-part trial includes an open-label, dose-finding portion (Part 1) and a randomized, observer-blinded, placebo-controlled expansion study (Part 2).
In Part 1 of the trial, participants 2 to less than 12 years old may receive either a 50μg or 100μg dose (the 100μg dose is currently authorized for use in adults under Emergency Use Authorization), while those 6 months to less than 2 years may receive 1 of 3 doses: 25μg, 50μg or 100μg. A dose for each age group will be selected and used in Part 2 of the trial, where participants will be followed through 12 months after the second vaccination.
The primary outcome of the study is vaccine effectiveness, which according to the Company, will either be inferred through achieving a correlate of protection or through immunobridging to the young adult (18-25 years old) population; safety and reactogenicity will also be evaluated.
“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,” said Stéphane Bancel, Chief Executive Officer of Moderna.
Additional trial information, including eligibility criteria, can be found here.
Moderna announces first participants dosed in phase 2/3 study of COVID-19 vaccine candidate in pediatric population. [press release]. Cambridge, MA: Moderna Inc.; March 16, 2021.