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

NCT06237296 ↗

Phase 1 Completed 558 enrolled Sanofi Pasteur, a Sanofi Company
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

EvaluationDrugModalityDoseRoute
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