drugset / Trial / NCT05375838
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.
Timeline
- Start
- 2022-05-13
- Primary completion
- 2022-12-29
- Completion
- 2022-12-29
Publications
- Rudman Spergel AK, Henry C, Nachbagauer R, Kaplonek P, Astley E, Avanesov A, Bertera H, Carmona L, Cizmeci D, Collins A, Embry A, Guo R, Mao X, Pucci A, Shao S, Shih-Lu-Lee J, Yu WH, Brune D, Chu L, Irfan M, Alter G, Ananworanich J, Shaw CA. Phase 1/2 randomized, observer-blind clinical trial of a first-generation, mRNA-based vaccine against seasonal influenza and COVID-19 in healthy adults. Hum Vaccin Immunother. 2026 Dec;22(1):2589644. doi: 10.1080/21645515.2025.2589644. Epub 2026 Feb 2.
- Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Akache B, Renner TM, Deschatelets L, Dudani R, Harrison BA, McCluskie MJ, Hrapovic S, Blouin J, Wang X, Schuller M, Cui K, Cho JY, Durocher Y. SARS-CoV-2 spike-based virus-like particles incorporate influenza H1/N1 antigens and induce dual immunity in mice. Vaccine. 2024 Dec 2;42(26):126463. doi: 10.1016/j.vaccine.2024.126463. Epub 2024 Oct 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elasomeran | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | Quadrivalent influenza vaccine | Vaccine | 50 ug | — |
| Subject | mRNA-1073 | Messenger RNA (mRNA) | 25 ug | Intramuscular |
| Subject | mRNA-1073 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | mRNA-1073 | Messenger RNA (mRNA) | 100 ug | Intramuscular |