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Can a new vaccine shield older adults from RSV?

NCT ID NCT05639894

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial evaluates an experimental vaccine designed to protect against respiratory syncytial virus (RSV), a common virus that can be severe in older adults. The study includes healthy adults aged 18 to 50 in an early phase, and adults 60 and older in a later phase. Participants receive either one of several vaccine doses or a placebo, and researchers monitor safety and measure the immune response, including neutralizing antibodies against RSV types A and B. The goal is to find a dose that is both safe and effective for further development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
An experimental RSV vaccine candidate formulated with lipid nanoparticles, given as an injection
What this could lead to
If successful, this could lead to a new vaccine that protects older adults from severe RSV infections.
What could go wrong
This is an early-stage trial, so the vaccine may not produce a strong immune response or could cause side effects. Results may not generalize to the broader population.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

865 people

The number who actually took part.

Started

Nov 2022

Finished

May 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

18 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: * Sentinel Cohort Stage 1: Aged 18 to 50 years on the day of inclusion * Main Cohort Stage 1 and Stage 2: Aged 60 years or older on the day of inclusion Stage 1 and Stage 2: * Sentinel Cohort: A female participant was eligible to participate if she was not pregnant or breastfeeding and: * Was of non-childbearing potential. To be considered of non-childbearing potential, a female must have been postmenopausal for at least 1 year or surgically sterile OR * Was of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration. * Main and Booster Cohorts: A female participant was eligible to participate if she was not pregnant or breastfeeding and: * Was of non-childbearing potential. To be considered of non-childbearing potential, a female must have been postmenopausal for at least 1 year or surgically sterile. * Able to attend all scheduled visits and to comply with all study procedures * Informed consent form was been signed and dated Exclusion Criteria: * 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 mRNA COVID-19 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 or bleeding disorder, contraindicating IM injection based on investigator's judgment * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection * Chronic illness that, in the opinion of the investigator, was 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 immune globulins, blood, or blood-derived products in the past 3 months * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * 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 * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Self-reported or documented human immunodeficiency virus (HIV) detected by any FDA-approved/validated test, hepatitis B virus surface antigen (HBsAg), hepatits B core antibodies (HBcAb), or hepatitis C virus antibodies (HCV Abs), or positive SARS-CoV-2 RT-PCR or antigen test * Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study The above information was not intended to contain all considerations relevant to a 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.

Respiratory syncytial virus immunization

Contacts and locations

Locations

  • AES Peoria Site Number : 8400030

    Peoria, Illinois, 61614, United States

  • Aventiv Research Columbus Site Number : 8400007

    Columbus, Ohio, 43213, United States

  • Aventiv Research Mesa Site Number : 8400020

    Mesa, Arizona, 85210, United States

  • Be Well Clinical Studies -Round Rock Site Number : 8400038

    Round Rock, Texas, 78681, United States

  • Be Well Clinical Studies Site Number : 8400036

    Lincoln, Nebraska, 68516, United States

  • CVS Health - Peoria Site Number : 8400042

    Peoria, Arizona, 85381, United States

  • CVS Health - Phoenix Site Number : 8400041

    Phoenix, Arizona, 85019, United States

  • CVS Health - Thousand Oaks Site Number : 8400043

    Thousand Oaks, California, 91361, United States

  • Cenexel Research Centers of America Site Number : 8400024

    Hollywood, Florida, 33024, United States

  • Centricity Research - Georgia Site Number : 8400009

    Rincon, Georgia, 31326, United States

  • Coastal Carolina Research Center Site Number : 8400015

    North Charleston, South Carolina, 29405, United States

  • DM Clinical Research - Chicago Site Number : 8400027

    River Forest, Illinois, 60305, United States

  • DM Clinical Research - CyFair Site Number : 8400025

    Houston, Texas, 77065, United States

  • IMA Clinical Research-San Antonio Site Number : 8400039

    San Antonio, Texas, 78229, United States

  • Investigational Site Number : 0360001

    Southport, 4215, Australia

  • Investigational Site Number : 0360002

    Camberwell, Victoria, 3124, Australia

  • Investigational Site Number : 0360003

    Botany, New South Wales, 2019, Australia

  • Investigational Site Number : 6300001

    San Juan, 00909, Puerto Rico

  • Investigational Site Number : 6300002

    San Juan, 00918, Puerto Rico

  • Investigational Site Number : 6300003

    Guayama, 000784, Puerto Rico

  • Investigational Site Number : 6300004

    Carolina, 984, Puerto Rico

  • Investigational Site Number : 6300005

    Guaynabo, 00968, Puerto Rico

  • Lynn Institute of Norman Site Number : 8400023

    Norman, Oklahoma, 73072, United States

  • Martin Diagnostic Clinic Site Number : 8400026

    Tomball, Texas, 77375, United States

  • Optimal Research Alabama Site Number : 8400032

    Huntsville, Alabama, 35802, United States

  • Peninsula Research Associates Site Number : 8400013

    Rolling Hills Estates, California, 90274, United States

  • Suncoast Research Associates, LLC Site Number : 8400003

    Miami, Florida, 33173, United States

  • Velocity Clinical Research - Providence Site Number : 8400006

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research - San Diego - ERN - PPDS Site Number : 8400010

    La Mesa, California, 91942, United States

  • Velocity Clinical Research Site Number : 8400017

    Cleveland, Ohio, 44122, United States

  • Velocity Clinical Research Site Number : 8400018

    West Jordan, Utah, 84088-8865, United States

  • Velocity Clinical Research Site Number : 8400019

    Cincinnati, Ohio, 45242, United States

  • Velocity Clinical Research, Medford Site Number : 8400014

    Medford, Oregon, 97504, United States

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