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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2025-09-11

No results posted yet for this study

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

Conditions

  • Respiratory Syncytial Virus Infection
  • Healthy Volunteers
  • Metapneumovirus Infection

Interventions

BIOLOGICAL

RSV/hMPV mRNA LNP 1

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

BIOLOGICAL

RSV/hMPV mRNA LNP 2

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

BIOLOGICAL

RSV mRNA LNP 1

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

BIOLOGICAL

hMPV mRNA LNP 1

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2025-02-11
Completion
2025-02-11
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237296 on ClinicalTrials.gov