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New nasal spray vaccine shows promise against RSV in young children

NCT ID NCT04491877

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study tested a live-attenuated RSV vaccine given as a nasal spray in 259 infants and toddlers aged 6 to 18 months. The main goals were to check safety and measure the immune response. Researchers also looked at how much vaccine virus was shed and how well the vaccine worked in children with and without prior RSV exposure.

What this could mean

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

Active substance
Live-attenuated respiratory syncytial virus (RSV) vaccine given as a nasal spray
What this could lead to
If successful, this could lead to a safe and effective nasal spray vaccine that protects infants and toddlers from RSV, a common cause of severe respiratory illness.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 259 participants, so results may not apply to all children. The vaccine is live-attenuated, meaning there is a small risk of vaccine-related illness or shedding.

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

259 people

The number who actually took part.

Started

Sep 2020

Finished

Apr 2023

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

6 to 18 months

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: Inclusion criteria : * Aged 6 through 18 months at Day 0. * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness if required by local regulations). * Participant and parent / guardian / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria: * Born at less than 34 weeks gestation * Born at less than 37 weeks gestation and less than 1 year of age at the time * 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). * Probable or confirmed case of Coronavirus Disease 2019 (COVID-19). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances * Any chronic illness • Chronic illness may include, but is not limited to, cardiac disorders, lung disease (including any history of reactive airway disease, receipt of bronchodilator therapy, or medically diagnosed wheezing), renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases * Any history of medically diagnosed wheezing * Any acute febrile, respiratory or gastrointestinal illness in the past 24 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * Any previous anaphylactic reaction * Current suspected or documented developmental disorder, delay, or other developmental problem * Receipt of any of the following vaccines prior to enrollment: * any influenza vaccine within 7 days prior, or * any inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or * any live vaccine, other than rotavirus vaccine, within the 28 days prior, or * another investigational vaccine or investigational drug within 28 days prior * Previous receipt of a licensed or investigational RSV vaccine or previous receipt or planned administration of any anti-RSV product (such as ribavirin or RSV immune immune globulins \[IG\] or RSV monoclonal antibody) * Receipt of immune globulins, blood or blood-derived products in the past 6 months prior to enrolment * Receipt of any of the following medications within 3 days prior to study enrollment (Day 0): * systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or * intranasal medications, or * other prescription medication except as permitted concomitant medications (prescription or non-prescription) including nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents * Receipt of salicylate (aspirin) or salicylate-containing products within the 28 days prior to enrollment (Day 0) * Any previous vaccine-associated adverse reaction that was Grade 3 or above. Note: if grading is not possible, determine if the reaction was considered severe or life threatening; if so, it is exclusionary. * Scheduled administration of the following after planned inoculation: * any influenza vaccine within 7 days after, or * inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or * any live vaccine other than rotavirus in the 28 days after, or * another investigational vaccine or investigational drug in the 56 days after. * Any previous receipt of supplemental oxygen therapy in a home or hospital setting, except the temporary receipt of supplemental oxygen for transient tachypnea in newborn * Member of a household that contains an immunocompromised individual, including, but not limited to: * a person who is HIV infected * a person who has received chemotherapy within the 12 months prior to enrollment * a person receiving immunosuppressant agents * a person living with a solid organ or bone marrow transplant * Participation at the time of study enrollment (or in the 6 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Member of a household that contains, or will contain, an infant who is less than 6 months of age at the enrollment date (or in the 6 weeks preceding the first trial vaccination) through Day 28 * Member of a household that contains another child/other children who is/are, or is/are scheduled to be, enrolled in this study in the same year AND the date of enrollment will not be concurrent with the other participant(s) living in the household (i.e., all eligible children from the same household must be enrolled on the same date) * Attends a daycare facility and shares a daycare room with infants less than 6 months of age, and parent/guardian is unable or unwilling to suspend daycare for 28 days following inoculation * Deprived of freedom in an emergency setting or hospitalized involuntarily * Identified as a 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 participant'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.

Respiratory syncytial virus infection

Contacts and locations

Locations

  • AMR - Newton-Site Number:8400002

    Newton, Kansas, 67114, United States

  • Alliance for Multispeciality Research-Site Number:8400014

    El Dorado, Kansas, 67042, United States

  • Be Well Clinical Studies-Site Number:8400054

    Lincoln, Nebraska, 68516, United States

  • Benchmark Research-Site Number:8400006

    Covington, Louisiana, 70433, United States

  • Boeson Research-Site Number:8400011

    Missoula, Montana, 59804, United States

  • California Research Foundation-Site Number:8400016

    San Diego, California, 92123-1881, United States

  • Clinical Research Institute-Site Number:8400053

    Minneapolis, Minnesota, 55402, United States

  • Coastal Pediatric Research-Site Number:8400031

    Charleston, South Carolina, 29414, United States

  • East Carolina University/Brody Medical Sciences Building-Site Number:8400043

    Greenville, North Carolina, 27834, United States

  • Elite Clinical Trials, Inc.-Site Number:8400001

    Blackfoot, Idaho, 83221, United States

  • FMC Science-Site Number:8400042

    Lampasas, Texas, 76550-1820, United States

  • Investigational Site Number :1520001

    Santiago, Reg Metropolitana de Santiago, 8380453, Chile

  • Investigational Site Number :1520004

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number :3400001

    San Pedro Sula, 21104, Honduras

  • Investigational Site Number :3400002

    Tegucigalpa, 11101, Honduras

  • JBR Clinical Research-Site Number:8400041

    Salt Lake City, Utah, 84107, United States

  • Leavitt Clinical Research-Site Number:8400036

    Idaho Falls, Idaho, 83404, United States

  • Matrix Clinical Research-Site Number:8400012

    Gardena, California, 90247, United States

  • Matrix Clinical Research-Site Number:8400032

    Los Angeles, California, 90057, United States

  • MedPharmics Inc-Site Number:8400040

    Albuquerque, New Mexico, 87102, United States

  • Meridian Clinical Research - Norfolk-Site Number:8400005

    Norfolk, Nebraska, 68701, United States

  • Michael W. Simon, MD, PSC-Site Number:8400013

    Lexington, Kentucky, 40517, United States

  • National Clinical Research Inc-Site Number:8400004

    Richmond, Virginia, 23294, United States

  • Nola Research Works-Site Number:8400017

    New Orleans, Louisiana, 70125, United States

  • Paradigm Clinical Research-Site Number:8400026

    La Mesa, California, 91942, United States

  • Pediatric Associates of Charlottesville North-Site Number:8400007

    Charlottesville, Virginia, 22911, United States

  • Snake River Research-Site Number:8400022

    Idaho Falls, Idaho, 83404, United States

  • The South Bend Clinic Center for Research-Site Number:8400024

    South Bend, Indiana, 46617, United States

  • Tribe Clinical Research-Site Number:8400027

    Greenville, South Carolina, 29607, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.