drugset / Trial / NCT04649151
A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
Phase 2/3
Completed
4328 enrolled
ModernaTX, Inc.
Biomedical Advanced Research and Development Authority · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety, reactogenicity, and effectiveness of mRNA-1273 vaccine administered as primary series and a booster dose (BD) to an adolescent population. The study will also evaluate the safety and immunogenicity of an mRNA-1273.222 vaccine against the SARS-CoV- 2 omicron variant as a primary series.
Timeline
- Start
- 2020-12-09
- Primary completion
- 2024-06-14
- Completion
- 2024-06-14
Publications
- Figueroa AL, Torres D, Reyes-Acuna C, Matherne P, Yeakey A, Deng W, Xu W, Sigal Y, Chambers G, Olsen M, Girard B, Miller JM, Das R, Priddy F. Safety and immunogenicity of a single-dose omicron-containing COVID-19 vaccination in adolescents: an open-label, single-arm, phase 2/3 trial. Lancet Infect Dis. 2025 Feb;25(2):208-217. doi: 10.1016/S1473-3099(24)00501-2. Epub 2024 Sep 24.
- Ali K, Berman G, Zhou H, Deng W, Faughnan V, Coronado-Voges M, Ding B, Dooley J, Girard B, Hillebrand W, Pajon R, Miller JM, Leav B, McPhee R. Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents. N Engl J Med. 2021 Dec 9;385(24):2241-2251. doi: 10.1056/NEJMoa2109522. Epub 2021 Aug 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elasomeran | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | Elasomeran | Messenger RNA (mRNA) | 100 ug | Intramuscular |
| Subject | mRNA-1273.222 | Vaccine | 50 ug | Intramuscular |