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New RSV vaccine shows promise for seniors in large trial

NCT ID NCT06251024

Vaccine Sponsor: Sanofi Pasteur, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental RSV vaccine in about 4500 adults aged 60 and older. Half received the vaccine and half received a placebo shot. The goal was to see if the vaccine could prevent lower respiratory tract disease caused by RSV, a common virus that can be serious in older adults.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

4,541 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 60 years or older on the day of inclusion * A female participant is eligible to participate if she is not pregnant or breastfeeding and: • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile. * Participants with high-risk medical conditions who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances ;any allergic reaction (eg, anaphylaxis) after administration of an mRNA vaccine * History of RSV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months * Previous history of myocarditis, pericarditis, and/or myopericarditis * Thrombocytopenia, contraindicating IM injection based on investigator's judgment * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion * Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion * Receipt of any vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine in the 4 weeks following any study intervention administration * Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration * Previous vaccination against RSV with a licensed or investigational vaccine or planned receipt during study participation, of vaccination against RSV with a licensed or investigational vaccine other than the study vaccine * Receipt of immune globulins, blood, or blood-derived products in the past 3 months * Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers Respiratory syncytial virus infection

Contacts and locations

Locations

  • Investigational Site Number : 0360001

    Southport, Queensland, 4222, Australia

  • Investigational Site Number : 0360002

    Camberwell, Victoria, 3124, Australia

  • Investigational Site Number : 0360003

    Botany, New South Wales, 2019, Australia

  • Investigational Site Number : 0360004

    Sippy Downs, Queensland, 4556, Australia

  • Investigational Site Number : 0360005

    Norwood, 5067, Australia

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8380453, Chile

  • Investigational Site Number : 1520002

    Santiago, 7500657, Chile

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number : 1520006

    Concepción, Biobio, 4070094, Chile

  • Investigational Site Number : 1520008

    Santiago, 7510157, Chile

  • Investigational Site Number : 1700001

    Quindío, 630001, Colombia

  • Investigational Site Number : 1700002

    Barranquilla, 080020, Colombia

  • Investigational Site Number : 1700003

    Girardot, 252431, Colombia

  • Investigational Site Number : 1700004

    Aguazul, 856010, Colombia

  • Investigational Site Number : 1700005

    Ibague, 730001, Colombia

  • Investigational Site Number : 1700006

    Bogotá, 110111, Colombia

  • Investigational Site Number : 1700007

    Cali, 76001, Colombia

  • Investigational Site Number : 2140001

    Santo Domingo, 10205, Dominican Republic

  • Investigational Site Number : 2140002

    Santo Domingo, 10205, Dominican Republic

  • Investigational Site Number : 3400001

    San Pedro Sula, 21104, Honduras

  • Investigational Site Number : 3400002

    Tegucugalpa, 11101, Honduras

  • Investigational Site Number : 3400003

    Tegucigalpa, 11101, Honduras

  • Investigational Site Number : 4840002

    León, Guanajuato, 37000, Mexico

  • Investigational Site Number : 4840003

    Querétaro, 76100, Mexico

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