New mRNA vaccine aims to shield toddlers from two winter viruses
NCT ID NCT05743881
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing two mRNA vaccines in children aged 5 months to under 24 months. One vaccine targets RSV alone, and the other targets both RSV and hMPV. The main goals are to check safety and see how well the vaccines trigger an immune response. About 186 children will take part, receiving either a vaccine or a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mRNA vaccines (mRNA-1345 and mRNA-1365)
- What this could lead to
- If successful, this could lead to a single vaccine that protects young children against two common respiratory viruses, RSV and hMPV.
- What could go wrong
- This is an early Phase 1 trial with only 186 participants, so safety and effectiveness are not yet proven. The vaccines may cause side effects or fail to provide strong protection.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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186 people
The number who actually took part.
- Started
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Feb 2023
- Expected to finish
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Aug 2029
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 24 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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.
Inclusion Criteria: * The participant is 8 months to \<24 months (Part A), 5 months to \<8 months (Part B), or 8 months to \<12 months (Part C) of age at the time of randomization (Day 1/Baseline visit), who is in good general health, in the opinion of the Investigator, based on review of medical history and screening physical examination. * In the Investigator's opinion, the parent(s)/ legally authorized representative (LAR)(s) understand and are willing and physically able to comply with protocol-mandated follow up, including all procedures, and provide written informed consent. * The participant is growing normally for age in the opinion of the site clinician in the months prior to enrollment. * The participant was born at full-term (≥37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg). * For Part C Cohort 7: participant must have received nirsevimab ≥6 months prior to Day 1 Visit. * For Part C Cohort 8: participant was eligible at any time since birth, according to national guidelines, to receive nirsevimab prior to Day 1 Visit but did not do so. Exclusion Criteria: * Has a known history of symptomatic RSV (Part A: within 3 months; Part B and Part C: since birth) or hMPV infection (Part A: within 3 months; Part B: since birth) prior to administration of the first dose of investigational product (IP) or has a known close contact with anyone with laboratory-confirmed RSV (Parts A, B, and C) or hMPV infection (Parts A or B) within 14 days prior to administration of the first dose of IP. * Is acutely ill or febrile 24 hours prior to or at the screening visit. Fever is defined as a body temperature ≥38.0°Celsius/≥100.4°Fahrenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. * Has previously been administered an investigational or approved vaccine for prevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) infection or if the participant's mother received an investigational or approved vaccine for the prevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) infection during pregnancy. * Has received investigational or approved agents for prophylaxis against RSV or hMPV (for example, monoclonal antibodies) or is intending to receive these during the course of the study. For Part C (Cohort 7 only), use of nirsevimab ≥6 months before Day 1 Visit is allowed. * Has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to a previous dose of an mRNA vaccine or any of its components (including polyethylene glycol or immediate allergic reaction of any severity to polysorbate). * Has a medical condition that, according to the Investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results. Note: Other protocol-defined inclusion/exclusion criteria apply. Inclusion Criteria: * For Part B Extension: participants enrolled and dosed in Part B (Cohorts 3 to 6); either reached the end of study of the Main Study or were dosed and subsequently discontinued from the Main Study. This includes participants who were lost to follow-up, if they can be re-engaged. * For Part B Extension: participant's parent(s)/LAR(s) has provided written informed consent for participation in Part B of the Main Study and the Part B Extension. Exclusion Criteria: • For Part B Extension, there are no specific exclusion criteria.
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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.
Contacts and locations
Locations
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CEVAXIN 24 de Diciembre
Panama City, Panama
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CEVAXIN Avenida Mexico
Panama City, 0801, Panama
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CEVAXIN Chorrera
La Chorrera, Panamá Oeste Province, Panama
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CEVAXIN David
David, Chiriquí Province, 0401, Panama
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CyFair
Houston, Texas, 77065, United States
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DM Clinical Research- River Forest
Melrose Park, Illinois, 60160, United States
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Duke Vaccine and Trials Unit
Durham, North Carolina, 27703, United States
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Matrix Clinical Research
Los Angeles, California, 90057, United States
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MedPharmics - Platinum - PPDS
Lafayette, Louisiana, 70508, United States
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Meridian Clinical Research
Washington D.C., District of Columbia, 20016, United States
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Norfolk and Norwich University Hospitals
Norwich, NR4 7UY, United Kingdom
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Palmetto Pediatrics, PA
North Charleston, South Carolina, 29406-9170, United States
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Pediatric Associates
Houston, Texas, 77087, United States
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Pediatric Center
Richmond, Texas, 77469, United States
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Vanderbilt Vaccine Research Program
Nashville, Tennessee, 37232, United States
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Velocity Clinical Research - Providence
Providence, Rhode Island, 02886, United States
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Village Pediatrics
Plano, Texas, 75024, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One shot, two viruses: vaccine aims to shield older adults from RSV and HMPV
- Can an mRNA vaccine shield the most vulnerable from RSV?
- Can an mRNA vaccine shield vulnerable children from RSV?
- Could a vaccine given during pregnancy shield infants from a deadly virus?
- Nasal spray vaccine aims to protect kids from two breathing viruses
- Moderna's mRNA vaccine cocktail passes early safety check