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
Outcome
Met primary endpoint
paper findings that met the noninferiority criteria for immune responses for both age cohorts. PMID 36260859 ↗
paper findings that met the prespecified noninferiority success criterion. PMID 35544369 ↗
paper met prespecified noninferiority success criteria versus responses observed after the primary series in young adults. PMID 39158584 ↗
release “met the co-primary immunogenicity endpoints for 6 to less than 12 years olds in KidCOVE.” q4web.com ↗
release “Two 25 μg doses of mRNA-1273 in participants 6 months to under 6 years met primary endpoint with robust neutralizing antibody titers similar to adults” q4web.com ↗
release “The Phase 2/3 KidCOVE study in children 6 months to under 6 years has successfully met its primary endpoint.” q4web.com ↗
release “under six years age sub-groups met the statistical criteria for similarity to the adults in the COVE Study, which satisfied the primary objective” q4web.com ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mRNA-1273 | Messenger RNA (mRNA) | 10 ug | Intramuscular |
| Subject | mRNA-1273 | Messenger RNA (mRNA) | 25 ug | Intramuscular |
| Subject | mRNA-1273 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | mRNA-1273 | Messenger RNA (mRNA) | 100 ug | Intramuscular |
| Subject | mRNA-1273.214 | Messenger RNA (mRNA) | — | Intramuscular |