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Study on the Effectiveness and Safety of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Toddlers

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease called Respiratory Syncytial Virus (RSV), which is a common virus that can cause infections in the lungs and respiratory tract. The study will use a treatment known as the Live Attenuated Respiratory Syncytial Virus (RSV) ΔNS2/Δ1313/I1314L vaccine, which is administered as a nasal spray. This vaccine is designed to help the body build protection against RSV.

The purpose of the study is to evaluate how well this vaccine works in preventing RSV infections in infants and toddlers. Participants in the study will receive two doses of the vaccine. The study will observe the effects of the vaccine over the course of the RSV season, which is the time of year when RSV infections are most common. The study will also include a group that receives a placebo to compare the results.

Throughout the study, researchers will monitor the health of the participants to ensure their safety and to gather information on how the vaccine affects the immune system. The study aims to provide valuable insights into the vaccine's ability to prevent RSV-related illnesses, such as lower respiratory tract disease, which affects the lungs and can lead to more serious health issues. The study is expected to continue until 2026, with recruitment starting in 2024.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be assessed to ensure you meet the eligibility criteria. This includes being between 6 months and less than 22 months old, being healthy, and having been born at full term (37 weeks or more).
Step 2
First vaccination
You will receive the first dose of the Live Attenuated Respiratory Syncytial Virus (RSV) ΔNS2/Δ1313/I1314L vaccine as a nasal spray. This is a liquid that is sprayed into your nose.
After receiving the vaccine, you will be observed for 30 minutes to monitor for any immediate reactions.
Step 3
Monitoring after first dose
For 21 days after the first vaccination, you will be monitored for any reactions at the site of administration and any general reactions.
You will also be monitored for any unexpected adverse events for 28 days after the vaccination.
Step 4
Second vaccination
You will receive a second dose of the vaccine as a nasal spray. This will occur after a specified period following the first dose.
Similar to the first dose, you will be observed for 30 minutes after receiving the vaccine.
Step 5
Monitoring after second dose
For 21 days after the second vaccination, you will be monitored for any reactions at the site of administration and any general reactions.
You will also be monitored for any unexpected adverse events for 28 days after the vaccination.
Step 6
Ongoing monitoring
Throughout the study, you will be monitored for any serious adverse events or events of special interest.
Your health will be checked regularly to ensure your safety and to gather data on the vaccine's effectiveness.
Step 7
End of study
The study is expected to end by September 30, 2026. Your participation will contribute to understanding the vaccine's efficacy and safety in preventing respiratory syncytial virus infections.

Who can join the trial?

3 criteria

Aged 6 months to less than 22 months on the day of inclusion (this means from the day of the 6-month birthday to the day before the 22-month birthday).
Participants who are healthy as determined by a medical evaluation, which includes reviewing their medical history.
Born at full term of pregnancy, which means the pregnancy lasted 37 weeks or more.

Who cannot join the trial?

7 criteria

Patients with any **virus diseases** cannot participate. This means if you have an illness caused by a virus, you are not eligible.
Patients who are not within the specified age range cannot participate. The study is for a specific age group.
Patients who are not willing to follow the study procedures cannot participate. This means you must agree to follow all the rules and steps of the study.
Patients who have received another investigational drug or vaccine within a certain time frame before the study cannot participate. This means if you have taken part in another study recently, you may not be eligible.
Patients with a history of severe allergic reactions cannot participate. This refers to serious allergies that might cause a strong reaction.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the child.
Patients with any condition that the study doctors think might make it unsafe for them to participate cannot join. This means if the doctors believe the study could harm you, you will not be allowed to join.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Hospital Universitario De Navarra
Pamplona, Spain
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Rokotetutkimuskeskus Finvac Oy
Tampere, Finland
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Universidade De Santiago De Compostela
Santiago De Compostela, Spain

Trial locations

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Investigated drugs

RSVt vaccine is a vaccine being tested to see if it can protect infants and toddlers from getting sick with a virus called Respiratory Syncytial Virus, or RSV. RSV is a common virus that can cause serious lung infections, especially in young children. The vaccine is given in two doses and the study is checking if it can prevent these infections during the time of year when RSV is most common. The goal is to see if the vaccine can help keep children healthy by stopping the virus from causing lung problems.

What is already known about the treatment

RSVt vaccine – This vaccine is administered through an injection and is designed to protect infants and toddlers from respiratory syncytial virus (RSV) infections. Currently, it is being studied in a Phase III clinical trial to assess its effectiveness, safety, and ability to trigger an immune response. The main goal is to prevent RSV-related lower respiratory tract diseases, which are confirmed through specific testing methods. The vaccine works by stimulating the body's immune system to recognize and fight the virus, helping to prevent illness during the RSV season. It falls under the category of vaccines, which are substances used to stimulate the production of antibodies and provide immunity against diseases.

Investigated diseases

Respiratory Syncytial Virus Infection – Respiratory Syncytial Virus (RSV) infection is a common viral infection that affects the respiratory tract. It typically begins with symptoms similar to a mild cold, such as a runny nose, cough, and fever. As the infection progresses, it can lead to more severe respiratory issues, particularly in young children and older adults. The virus can cause inflammation of the small airways in the lungs, known as bronchiolitis, and can also lead to pneumonia. In some cases, the infection may result in wheezing and difficulty breathing. The virus spreads easily through respiratory droplets and can be particularly severe during the RSV season, which typically occurs in the fall and winter months.