A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age

Summary

The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2).

Timeline

Start

2021-03-15

Primary completion

2024-03-15

Completion

2024-03-15

Publications

• Rostad CA, Campbell JD, Paulsen GC, Ghamloush SS, Xu W, Zheng L, McElrath MJ, De Rosa SC, Girard B, Das R, Anderson EJ, Creech CB. Evaluation of Cellular Immune Responses After mRNA-1273 Vaccination in Children 6 Months to 11 Years of Age. J Infect Dis. 2025 Jun 2;231(5):e945-e955. doi: 10.1093/infdis/jiaf144.
• Berthaud V, Creech CB, Rostad CA, Carr Q, de Leon L, Dietrich M, Gupta A, Javita D, Nachman S, Pinninti S, Rathore M, Rodriguez CA, Luzuriaga K, Towner W, Yeakey A, Brown M, Zhao X, Deng W, Xu W, Zhou H, Girard B, Kelly R, Slobod K, Anderson EJ, Das R, Miller J, Schnyder Ghamloush S. Safety and Immunogenicity of an mRNA-1273 Booster in Children. Clin Infect Dis. 2024 Dec 17;79(6):1524-1532. doi: 10.1093/cid/ciae420.
• 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.
• Anderson EJ, Creech CB, Berthaud V, Piramzadian A, Johnson KA, Zervos M, Garner F, Griffin C, Palanpurwala K, Turner M, Gerber J, Bennett RL, Ali K, Ampajwala M, Berman G, Nayak J, Chronis C, Rizzardi B, Muller WJ, Smith CA, Fuchs G, Hsia D, Tomassini JE, DeLucia D, Reuter C, Kuter B, Zhao X, Deng W, Zhou H, Ramirez Schrempp D, Hautzinger K, Girard B, Slobod K, McPhee R, Pajon R, Aunins A, Das R, Miller JM, Schnyder Ghamloush S; KidCOVE Study Group. Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. N Engl J Med. 2022 Nov 3;387(18):1673-1687. doi: 10.1056/NEJMoa2209367. Epub 2022 Oct 19.
• Creech CB, Anderson E, Berthaud V, Yildirim I, Atz AM, Melendez Baez I, Finkelstein D, Pickrell P, Kirstein J, Yut C, Blair R, Clifford RA, Dunn M, Campbell JD, Montefiori DC, Tomassini JE, Zhao X, Deng W, Zhou H, Ramirez Schrempp D, Hautzinger K, Girard B, Slobod K, McPhee R, Pajon R, Das R, Miller JM, Schnyder Ghamloush S; KidCOVE Study Group. Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. N Engl J Med. 2022 May 26;386(21):2011-2023. doi: 10.1056/NEJMoa2203315. Epub 2022 May 11.
• Lynch LR, Clifford H, Ko R, Hache M, Sun W. Primer of COVID-19 Vaccines for the Perioperative Physician. J Neurosurg Anesthesiol. 2022 Jan 1;34(1):101-106. doi: 10.1097/ANA.0000000000000802.

Drugs

Indications