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New RSV vaccine for infants shows promise in major trial

NCT ID NCT06397768

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 given to healthy infants at 6 and 12 months old alongside their regular vaccines. The goal was to see if the RSV vaccine still worked well when given at the same time. About 2,200 babies took part, but the study was stopped early.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,226 people

The number who actually took part.

Started

May 2024

Finished

Sep 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

6 to 12 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: * Aged 6 months for Cohort 1 and 12 months for Cohort 2 on the day of inclusion ("6 months" means from the day of the 6-month birthday to the day before the 7-month birthday and "12 months" means from the day of the 12-month birthday to the day before the 13-month birthday) * Participants who are healthy as determined by medical evaluation including medical history and physical examination * For Cohort 1: Infant received doses of vaccines containing hepatitis B, diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), and inactivated poliovirus vaccine (IPV) antigens, with Advisory Committee on Immunization Practice (ACIP) recommended vaccines. The last dose(s) of these vaccines must be at least 28 days before the first study visit * Infant received the recommended doses of a recommended pneumococcal conjugate vaccine (as per local schedule) at least 28 days before the first study visit. 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 previous infection with diphtheria, tetanus, Hib, measles, mumps, rubella, rotavirus, pneumococcus, polio, hepatitis B virus * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion * History of medically diagnosed wheezing * Any acute febrile illness in the past 48 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. * Probable or confirmed ongoing case of viral respiratory infection (including COVID 19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved. * Member of a household that contains an immunocompromised individual, including, but not limited to: * A person living with human immunodeficiency virus (HIV) * A person who has received chemotherapy within the 12 months prior to study enrollment * A person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents * A person living with a solid organ or bone marrow transplant * Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator's discretion * History of definitive contraindications to any of the concomitant vaccines that will be administered as part of the study protocol * Participant's biological mother with previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding * Receipt of any vaccine in the 4 weeks preceding RSVt vaccine administration or planned receipt of any vaccine outside of study protocol in the 4 weeks following RSVt vaccine administration, except for influenza and/or COVID-19 vaccination, which may be received at least 1 week before or 1 week after RSVt vaccine administration * Previous receipt of an investigational RSV vaccine or receiving any anti RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment * Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration or planned receipt for duration of the study * For Cohort 1: Prior receipt of routine 6-month pediatric vaccine doses (as per local schedule) * For Cohort 2: Prior receipt of routine 12-month pediatric vaccine doses (as per local schedule) * Participation at the time of study enrollment (or in the 6 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 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.

RSV immunization

Contacts and locations

Locations

  • Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400007

    Birmingham, Alabama, 35205, United States

  • Alliance Research Institute - Bell Gardens - Garfield Avenue- Site Number : 8400040

    Bell Gardens, California, 90201, United States

  • Alliance for Multispeciality Research - El Dorado- Site Number : 8400019

    El Dorado, Kansas, 67042, United States

  • Boeson Research - Great Falls- Site Number : 8400041

    Great Falls, Montana, 59405, United States

  • Boeson Research - Missoula- Site Number : 8400006

    Missoula, Montana, 59804, United States

  • Cyn3rgy Research- Site Number : 8400053

    Gresham, Oregon, 97030, United States

  • DM Clinical Research - Houston - Jones Road- Site Number : 8400052

    Houston, Texas, 77065, United States

  • Dade Research Center- Site Number : 8400014

    Miami, Florida, 33126, United States

  • Dayton Clinical Research- Site Number : 8400030

    Dayton, Ohio, 45409, United States

  • Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400020

    Fort Worth, Texas, 76104, United States

  • Houston Clinical Research Associates- Site Number : 8400013

    Houston, Texas, 77090, United States

  • Integrated Clinical Research LLC- Site Number : 8400036

    Sherman Oaks, California, 91356-4173, United States

  • Investigational Site Number : 4840001

    Mexico City, Mexico City, 04530, Mexico

  • Investigational Site Number : 4840002

    Temixco, Morelos, 62587, Mexico

  • Investigational Site Number : 4840004

    Mexico City, 06760, Mexico

  • Investigational Site Number : 6300001

    Caguas, 00725, Puerto Rico

  • Investigational Site Number : 6300003

    Ponce, 00716, Puerto Rico

  • Investigational Site Number : 6300004

    Trujillo Alto, 00976, Puerto Rico

  • Javara - Privia Medical Group North Texas - Dallas- Site Number : 8400003

    Dallas, Texas, 75230, United States

  • Kaiser Permanente - Oakland Medical Center- Site Number : 8400047

    Oakland, California, 94611, United States

  • Kaiser Permanente - Point West Medical Offices- Site Number : 8400064

    Sacramento, California, 95815, United States

  • Kaiser Permanente - San Jose Medical Center- Site Number : 8400060

    San Jose, California, 95119, United States

  • Kaiser Permanente - Santa Clara Medical Center- Site Number : 8400061

    Santa Clara, California, 95051, United States

  • Kaiser Permanente - Sierra Gardens- Site Number : 8400063

    Roseville, California, 95661, United States

  • Kaiser Permanente - Walnut Creek Medical Center- Site Number : 8400062

    Walnut Creek, California, 94596, United States

  • La Providence Pediatrics & Family Clinics- Site Number : 8400039

    Houston, Texas, 77071, United States

  • Leavitt Women's Healthcare- Site Number : 8400009

    Idaho Falls, Idaho, 83404, United States

  • Matrix Clinical Research - Huntington Park- Site Number : 8400018

    Huntington Park, California, 90255, United States

  • Matrix Clinical Research - Los Angeles- Site Number : 8400008

    Los Angeles, California, 90057, United States

  • Maximos Ob/Gyn- Site Number : 8400024

    League City, Texas, 77573, United States

  • MedPharmics - Mobile - Dauphin Street- Site Number : 8400017

    Mobile, Alabama, 36608, United States

  • Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400045

    Houston, Texas, 77070, United States

  • Midwest Childrens Health Research Institute- Site Number : 8400038

    Lincoln, Nebraska, 68516, United States

  • NYU Langone Cardiothoracic Surgery Associates - Garden City- Site Number : 8400048

    Garden City, New York, 11530, United States

  • Neighbors Pediatrics- Site Number : 8400072

    Charleston, South Carolina, 29407, United States

  • North Houston Internal Medicine & Pediatric Clinic- Site Number : 8400025

    Tomball, Texas, 77375, United States

  • Northwest Arkansas Pediatric Clinic- Site Number : 8400002

    Fayetteville, Arkansas, 72703, United States

  • Ogden Clinic - Mountain View - CCT Research- Site Number : 8400056

    Pleasant View, Utah, 84404, United States

  • Ohio Pediatrics - Dayton- Site Number : 8400033

    Dayton, Ohio, 45414, United States

  • PAS Research - Children's Care Clinic- Site Number : 8400035

    Edinburg, Texas, 78539, United States

  • PAS Research - Henderson- Site Number : 8400049

    Henderson, Nevada, 89014, United States

  • PAS Research- Site Number : 8400005

    Tampa, Florida, 33613, United States

  • Paradigm Clinical Research Centers- Site Number : 8400059

    La Mesa, California, 91942, United States

  • Pas Research - Pittsburgh- Site Number : 8400043

    Pittsburgh, Pennsylvania, 15227, United States

  • Pediatric Center - Richmond- Site Number : 8400032

    Richmond, Texas, 77469, United States

  • Prohealth Research Center- Site Number : 8400068

    Doral, Florida, 33166, United States

  • QPS Bio-Kinetic Clinical Applications- Site Number : 8400046

    Springfield, Missouri, 65802, United States

  • Research Works INC- Site Number : 8400044

    New Orleans, Louisiana, 70125, United States

  • Research Your Health- Site Number : 8400066

    Plano, Texas, 75093, United States

  • Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400015

    Miami Lakes, Florida, 33014, United States

  • SEC Clinical Research - Pensacola- Site Number : 8400034

    Pensacola, Florida, 32501, United States

  • SUNY Upstate Medical University - Syracuse- Site Number : 8400029

    Syracuse, New York, 13210, United States

  • Senders Pediatrics- Site Number : 8400022

    South Euclid, Ohio, 44121, United States

  • South Alabama Medical Clinic- Site Number : 8400065

    Grand Bay, Alabama, 36541, United States

  • South Texas Clinical Research- Site Number : 8400004

    Corpus Christi, Texas, 78413, United States

  • Square-1 Clinical Research- Site Number : 8400031

    Erie, Pennsylvania, 16506, United States

  • Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400070

    Palo Alto, California, 94304, United States

  • Summerwood Pediatrics- Site Number : 8400021

    Liverpool, New York, 13088, United States

  • The Medici Medical Research- Site Number : 8400055

    Hollywood, Florida, 33021, United States

  • The University of Texas Health Science Center- Site Number : 8400037

    Houston, Texas, 77030, United States

  • Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400012

    Greenville, South Carolina, 29607, United States

  • University of Kentucky Chandler Medical Center- Site Number : 8400051

    Lexington, Kentucky, 40536, United States

  • University of Texas Medical Branch at Galveston- Site Number : 8400057

    League City, Texas, 77555, United States

  • Utah Valley Pediatrics - Orem- Site Number : 8400067

    Orem, Utah, 84057, United States

  • Velocity Clinical Research - Grand Island- Site Number : 8400016

    Grand Island, Nebraska, 68803, United States

  • Velocity Clinical Research - Gulfport- Site Number : 8400011

    Gulfport, Mississippi, 39503, United States

  • Velocity Clinical Research - New Orleans- Site Number : 8400058

    New Orleans, Louisiana, 70119, United States

  • Velocity Clinical Research - Omaha- Site Number : 8400001

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research - Sioux City- Site Number : 8400054

    Sioux City, Iowa, 51106, United States

  • Velocity Clinical Research - Washington DC- Site Number : 8400050

    Washington D.C., District of Columbia, 20016, United States

  • Ventavia Research Group - Houston - North Loop West- Site Number : 8400010

    Houston, Texas, 77008, United States

  • Wee Care Pediatrics - Roy- Site Number : 8400071

    Roy, Utah, 84067, United States

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