CompletedPhase 1

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

United States, Australia558 participantsStarted 2024-01-23

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

Informed consent form (ICF) has been signed and dated

Exclusion criteria

Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
-The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence of unsolicited systemic immediate adverse events (AEs)

Timeframe: Within 30 minutes after vaccination

Presence of solicited injection site or systemic reactions

Timeframe: Within 7 days after vaccination

Presence of unsolicited AEs

Timeframe: Within 28 days after vaccination

Presence of medically attended adverse events (MAAEs)

Timeframe: Throughout study (up to approximately 6 months)

Presence of serious adverse events (SAEs)

Timeframe: Throughout study (up to approximately 6 months)

Presence of adverse events of special interest (AESIs)

Timeframe: Throughout study (up to approximately 6 months)

Presence of out-of-range biological test results

Timeframe: Within 7 days after vaccination

Trial details

NCT IDNCT06237296

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-11

View on ClinicalTrials.gov More Respiratory Syncytial Virus Infection trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

Informed consent form (ICF) has been signed and dated

Exclusion criteria

Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
-The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

What they're measuring

Presence of unsolicited systemic immediate adverse events (AEs)

Timeframe: Within 30 minutes after vaccination

Presence of solicited injection site or systemic reactions

Timeframe: Within 7 days after vaccination

Presence of unsolicited AEs

Timeframe: Within 28 days after vaccination

Presence of medically attended adverse events (MAAEs)

Timeframe: Throughout study (up to approximately 6 months)

Presence of serious adverse events (SAEs)

Timeframe: Throughout study (up to approximately 6 months)

Presence of adverse events of special interest (AESIs)

Timeframe: Throughout study (up to approximately 6 months)

Presence of out-of-range biological test results

Timeframe: Within 7 days after vaccination