The KidCOVE study, which is set to enroll 6,750 healthy children in both the US and Canada, is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID).
Stéphane Bancel, CEO, Moderna, commented: “It is humbling to know that 17.8 million adults in the US have received the Moderna COVID-19 Vaccine to date. 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 KidCOVE study has two stages - an open label, dose-escalation, age de-escalation (Part 1) and a randomized, observer-blind, placebo-controlled expansion study (Part 2). The trial will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of Moderna COVID-19 Vaccine, given 28 days apart.
The trial is broken into two parts. In part one, different dosages of the vaccine are being tested on children, depending on the age range. Children between the ages of 6 months and 1 year old will receive two doses of the vaccine spaced about 28 days apart at either a 25 or a 50 or a 100-microgram level. Children between the ages of 2 and 11 will receive two doses of the vaccine spaced about 28 days apart at either a 50 or a 100-microgram level.
An interim analysis will then be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study. Participants will be followed through 12 months after the second vaccination.
Moderna also has a trial – TeenCove - with adolescents aged 12-18.
AstraZeneca/Oxford is testing the efficacy of their COVID-19 vaccine in children as well, but with those aged six and over.
The Pfizer/BioNTech Covid-19 vaccine is being studied in children aged 12+ in the US, while Johnson & Johnson has announced plans to study the vaccine in adolescents, ages 12 to 18.