A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age

Summary

This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to \<6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose (BD) given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2); and will evaluate the safety and immunogenicity of the mRNA-1273.815 vaccine, when administered as a BD in participants aged 6 months to \<6 years (Part 3) and when administered to SARS-CoV-2 vaccine-naïve participants aged 2 years to \<5 years of age (Part 4).

Timeline

Start

2022-06-21

Primary completion

2025-10-20

Completion

2025-10-20

Publications

• Dixit A, Bennett R, Ali K, Griffin C, Clifford RA, Turner M, Poston R, Hautzinger K, Yeakey A, Girard B, Zhou W, Deng W, Zhou H, Schnyder Ghamloush S, Kuter BJ, Slobod K, Miller JM, Priddy F, Das R; ROVER Study Investigators. Interim safety and immunogenicity of COVID-19 omicron BA.1 variant-containing vaccine in children in the USA: an open-label non-randomised phase 3 trial. Lancet Infect Dis. 2024 Jul;24(7):687-697. doi: 10.1016/S1473-3099(24)00101-4. Epub 2024 Mar 19.

Drugs

Indications