drugset / Trial / NCT06237296
Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older. Treatment: * RSV/hMPV mRNA / LNP 1 at 3-4 different doses or, * RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or, * RSV mRNA / LNP 1 at 1 dose or, * hMPV mRNA / LNP 1 at 1 dose
Timeline
- Start
- 2024-01-23
- Primary completion
- 2025-02-11
- Completion
- 2025-02-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RSV mRNA LNP 1 | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | RSV/hMPV mRNA LNP 1 | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | RSV/hMPV mRNA LNP 2 | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | hMPV mRNA LNP 1 | Messenger RNA (mRNA) | — | Intramuscular |