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New mRNA vaccine aims to shield toddlers from two winter viruses

NCT ID NCT05743881

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

186 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Aug 2029

An estimate. End dates often move.

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

5 to 24 months

Sex

Anyone

Healthy volunteers

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

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

  • CEVAXIN 24 de Diciembre

    Panama City, Panama

  • CEVAXIN Avenida Mexico

    Panama City, 0801, Panama

  • CEVAXIN Chorrera

    La Chorrera, Panamá Oeste Province, Panama

  • CEVAXIN David

    David, Chiriquí Province, 0401, Panama

  • CyFair

    Houston, Texas, 77065, United States

  • DM Clinical Research- River Forest

    Melrose Park, Illinois, 60160, United States

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27703, United States

  • Matrix Clinical Research

    Los Angeles, California, 90057, United States

  • MedPharmics - Platinum - PPDS

    Lafayette, Louisiana, 70508, United States

  • Meridian Clinical Research

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

  • Norfolk and Norwich University Hospitals

    Norwich, NR4 7UY, United Kingdom

  • Palmetto Pediatrics, PA

    North Charleston, South Carolina, 29406-9170, United States

  • Pediatric Associates

    Houston, Texas, 77087, United States

  • Pediatric Center

    Richmond, Texas, 77469, United States

  • Vanderbilt Vaccine Research Program

    Nashville, Tennessee, 37232, United States

  • Velocity Clinical Research - Providence

    Providence, Rhode Island, 02886, United States

  • Village Pediatrics

    Plano, Texas, 75024, United States

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