- The first participants have been dosed in Moderna's (NASDAQ:MRNA) Phase 2/3 KidCOVE study, of mRNA-1273, in children ages 6 months to less than 12 years against COVID-19.
- This Phase 2/3 two-part, dose-escalation, age de-escalation (Part 1) and observer-blind, placebo-controlled expansion study (Part 2) will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart and enroll ~6,750 pediatric participants.
- Evaluation of vaccine safety and reactogenicity is also a primary endpoint of the study.
- In Part 1, each participant may receive one of two dose levels (50 μg or 100 μg) and participants age six months to less than 2 years may receive one of three dose levels (25 μg, 50 μg and 100 μg).
- An interim analysis will be conducted to determine which dose will be used in Part 2.
- Participants will be followed through 12 months after the second vaccination.
- Vaccine effectiveness will either be inferred through achieving a correlate of protection, or through immunobridging to the young adult (ages 18-25) population.