This is a Phase 2/3, 2-part, open-label, dose-escalation, age de-escalation, randomized, observer-blind, placebo-controlled, expansion study intended to infer the effectiveness of mRNA-1273 in children aged 6 months to less than 12 years.

Please access Kid COVE Study for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.

Results

On October 25, 2021 - Moderna announced positive top-line interim results for the Phase 2/3 study. These interim results were for the study population of 6 to <12 years old. This study was evaluating the safety, tolerability, reactogenicity, and effectiveness of two 50 µg doses of mRNA-1273 given to healthy children 28 days apart. The > 12 years old dosage is two 100  µg doses of mRNA-1273.

The enrollment for the 6 years to under 12 years is complete, but the Phase 2/3 study continues to enroll children ages 6 months to under 6 years of age.