Active not recruitingPHASE1INTERVENTIONAL

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Q: What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that causes cold-like symptoms, but it can lead to more serious breathing problems like bronchiolitis or pneumonia, especially in babies and young children.

Q: What is hMPV?

hMPV stands for human metapneumovirus. Like RSV, it's a respiratory virus that can cause coughs, colds, and sometimes more severe lung infections, particularly in young children, older adults, and people with weakened immune systems.

Q: What is an mRNA vaccine?

mRNA vaccines teach your body's cells how to make a piece of a virus protein. This protein doesn't cause illness but triggers your immune system to create antibodies, preparing your body to fight off the actual virus if you encounter it.

Q: Will my child get sick from the vaccine?

No, the vaccines being tested do not contain the live virus, so your child cannot catch RSV or hMPV from them. They might experience mild side effects like a sore arm or slight fever, similar to other routine vaccinations.

Q: What is a placebo?

A placebo is an inactive substance or treatment that looks exactly like the real vaccine but doesn't contain any active ingredients. It's used in studies to compare the effects of the actual vaccine against no treatment.

This study is looking into new vaccines for babies and young children (from 5 to 24 months old) that aim to protect against two common viruses: Respiratory Syncytial Virus (RSV) and human metapneumovirus (hMPV). These viruses can cause cold-like symptoms but can sometimes lead to more serious breathing problems, especially in very young children. The research team wants to find out if these new mRNA vaccines are safe to use and how well they help the body create protection (immunity) against these viruses. One vaccine targets both RSV and hMPV, while the other focuses only on RSV. Some participants will also receive a dummy treatment (placebo) or another approved vaccine to compare with the new vaccines.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

ModernaTX, Inc.

Enrolment target

186

Start

15 Feb 2023

Estimated completion

30 Sep 2026

Respiratory Syncytial Virus Human Metapneumovirus

What is this study about?

This study is designed to explore new ways to protect very young children from two specific viruses: Respiratory Syncytial Virus (RSV) and human metapneumovirus (hMPV). Both RSV and hMPV are common respiratory viruses that can cause colds, coughs, and sometimes more serious chest infections, particularly in babies and toddlers. Finding effective vaccines for these viruses is really important to help keep children healthy and reduce hospital visits.

The researchers are testing two new vaccines. One vaccine, called mRNA-1345, is designed to protect against RSV. The other, mRNA-1365, aims to protect against both RSV and hMPV. By giving these vaccines to children between 5 and 24 months old, the study hopes to understand if they are safe to use and how well the children's immune systems respond by creating protective antibodies. Some children will receive one of the new vaccines, while others might get a placebo (a dummy treatment with no active ingredients) or a standard vaccine called Nimenrix, depending on the study group they are in. This comparison helps researchers understand the new vaccines' effects.

This is a 'Phase 1' study, which means it's one of the first steps in testing a new treatment in humans. At this stage, the main goals are to make sure the vaccines are safe and to see if they can trigger an immune response, rather than proving they prevent illness. The information gathered from this study is crucial for deciding if these vaccines can move forward to larger studies, which aim to confirm their effectiveness.

Key takeaways

This study is testing new experimental vaccines for RSV and hMPV in babies and toddlers.
It aims to find out if the vaccines are safe and if they can kick-start the immune system.
Participants will be closely monitored by a medical team.
Joining a study is a personal decision, and you can withdraw at any time.
This is an early-stage study, so the long-term effects are not yet known.

Who may be eligible?

This study is looking for healthy babies and toddlers between 5 months and just under 2 years old (24 months). Children must generally be in good health, as decided by the study doctor after reviewing their medical history and a quick check-up.

Your child must have been born full-term (at least 37 weeks gestation) and weighed at least 2.5 kilograms (about 5.5 pounds) at birth. Importantly, your child should not have had RSV within the last 3 months, or hMPV within the last 3 months (or since birth for some groups). They also shouldn't have had close contact with someone with confirmed RSV or hMPV in the 2 weeks before starting the study.

Children won't be able to join if they have had an investigational or approved RSV or hMPV vaccine before. Also, if your child has a fever or is acutely ill on the day of screening, they wouldn't be able to start the study right away, but the visit might be rescheduled.

Quick self-check

Is my child between 5 months and just under 2 years old?
Is my child generally healthy with normal growth?
Was my child born full-term (at least 37 weeks gestation) and weighing at least 2.5kg?
Has my child NOT had RSV or hMPV recently (within the last 3 months or since birth for some groups)?
Has my child NOT had any experimental or approved RSV or hMPV vaccine before?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child joins this study, they will have several visits to the clinic over a period of time. These visits will involve health checks, and your child will receive either one of the new study vaccines, a placebo (a dummy injection), or Nimenrix, depending on which group they are in. There will be careful monitoring of your child's health after each dose, and some blood samples will be taken to see how their immune system is responding to the vaccine. The study team will need to stay in touch with you regularly to check on your child's well-being and any symptoms they might have. The total duration of participation for each child will vary depending on their group, but it typically involves follow-up for several months.

Potential risks and benefits

There is a potential benefit that your child might receive a vaccine that helps protect them against RSV and/or hMPV. However, as this is a new vaccine being tested, we don't yet know how effective it is, or if it has any unexpected side effects. Potential risks are similar to other vaccines, such as soreness or redness at the injection site, or a mild fever. The research team will monitor your child very closely for any side effects. You are free to withdraw your child from the study at any time, for any reason, without affecting their future medical care.

Locations (50)

Matrix Clinical Research
Los Angeles, United States
Los Angeles Children's Hospital
Los Angeles, United States
Velocity Clinical Research, Denver
Englewood, United States
Meridian Clinical Research
Washington D.C., United States
Meridian Clinical Research
Washington D.C., United States
University Of Florida Health Science Center
Jacksonville, United States
Accel Research Sites - Nona Pediatric Center
Orlando, United States
Clinical Research Prime
Idaho Falls, United States
MedPharmics - Platinum - PPDS
Lafayette, United States
Umass Memorial Medical Center
Worcester, United States
UMASS Chan Medical School
Worcester, United States
Henry Ford Health System
Detroit, United States

+38 more sites — see the official record for the full list.

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that causes cold-like symptoms, but it can lead to more serious breathing problems like bronchiolitis or pneumonia, especially in babies and young children.

What is hMPV?

hMPV stands for human metapneumovirus. Like RSV, it's a respiratory virus that can cause coughs, colds, and sometimes more severe lung infections, particularly in young children, older adults, and people with weakened immune systems.

What is an mRNA vaccine?