Can an RSV shot shield High-Risk kids?
NCT ID NCT07839871
First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time
Summary
Researchers are testing an RSV vaccine called RSVpreF in children aged 5 to under 18 who have chronic medical conditions or weakened immune systems. The trial measures whether the shot is safe, causes few side effects, and prompts the immune system to make antibodies against RSV. About 920 children join, and some receive a placebo for comparison.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an RSV vaccine called RSVpreF
- What this could lead to
- If it works, this could give doctors a way to protect children with chronic illnesses or weakened immune systems from severe RSV lung infections.
- What could go wrong
- The vaccine may not produce a strong immune response in children whose immune systems are compromised, and it could cause side effects. This trial is still testing safety and immune response, not whether it prevents RSV illness.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 920 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2031
An estimate. End dates often move.
- Lead sponsor
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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
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5 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
Key Inclusion Criteria: * Participants' age requirements for each study cohort at enrollment, respectively Cohort 1a (chronic medical conditions) 12 to \<18 years of age Cohort 1b (chronic medical conditions) 5 to \<12 years of age Cohort 2a (immunocompromising conditions) 12 to \<18 years of age Cohort 2b (immunocompromising conditions) 5 to \<12 years of age * Participants depending on the study cohort requirements, will be considered by the investigator to be at high risk of LRTI-RSV based on the following disease characteristics and definitions: Chronic medical conditions: * Cystic fibrosis * Medically treated asthma * Other chronic respiratory diseases and malformations of the lung * Trisomy 21 (Down syndrome) * Neuromuscular disease * Cerebral palsy * Hemodynamically significant or symptomatic congenital heart disease * Sickle cell disease * Confirmed stable HIV disease defined as documented viral load \<50 copies/mL and CD4 count \>200 cells/mm3 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months Immunocompromising conditions: * Immunomodulatory therapy: Is on an active immunosuppressive (including cytotoxic) or immunomodulatory therapy at a stable dose. Patients taking steroids as monotherapy must be on a dose of at least 2 mg/kg/day or 20 mg/day or greater OR * Primary immune deficiency: Has a diagnosed primary immunodeficiency disease OR * Cellular therapy: Has received a bone marrow or stem cell transplant at least 6 months (180 days) prior to enrollment with adequate immune reconstitution for immunization in the investigator's opinion or has received chimeric antigen receptor T cell (CAR-T) therapy more than 90 days prior to enrollment OR * Solid organ transplant: Has received a solid organ transplant at least 3 months prior and with no acute rejection episodes within 90 days prior to enrollment and is on ongoing immunosuppressive therapy OR * End-stage renal disease: Has end-stage renal disease (ESRD) on hemodialysis (HD) * Participants' weight must be: Cohort 1a: ≥30.0 kg at enrollment Cohort 1b: ≥14.5 kg at enrollment Cohort 2a : ≥30 kg at enrollment Cohort 2b: ≥14.5 kg at enrollment •The participant's parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written) Key Exclusion Criteria: * Applicable to Cohort 1 (a and b) participants only: Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination * Applicable to Cohort 1 (a and b) participants only: Individuals with a history of autoimmune disease, past or present, requiring therapeutic intervention including, but not limited to, systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection * Individuals with epilepsy or other seizure disorders that is uncontrolled/unstable, or a history of seizures and/or other neurological complications following vaccination * History of Guillain-Barré syndrome and/or acute polyneuropathy without an underlying etiology. * Individuals who are pregnant * Any medical or psychiatric condition, including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
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Senders Pediatrics
South Euclid, Ohio, 44121, United States
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