A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
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
Outcome
Met primary endpoint
paper which met the noninferiority criterion. PMID 34379915 ↗
paper superior (geometric mean ratio [GMR] 95% CI lower bound >1) neutralising antibody responses against omicron BA.4 and BA.5 PMID 39332418 ↗
paper non-inferior (GMR 95% CI lower bound >0·667) neutralising antibody responses against ancestral SARS-CoV-2 PMID 39332418 ↗
release “today announced that the Phase 2/3 study of its COVID-19 vaccine (mRNA-1273) in adolescents has met its primary immunogenicity endpoint” q4web.com ↗
release “Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary immunogenicity endpoint” q4web.com ↗
release “Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary immunogenicity endpoint” q4web.com ↗
release “Phase 2/3 study, which enrolled 3,732 participants ages 12 to less than 18 years in the U.S. The study met its primary endpoint” q4web.com ↗
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 | mRNA-1273 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | mRNA-1273 | Messenger RNA (mRNA) | 100 ug | Intramuscular |
| Subject | mRNA-1273.222 | Vaccine | 50 ug | Intramuscular |