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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 study about?

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.

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).

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain
Kinderarztpraxis Leyental Krefeld Germany
FVR Suomen rokotetutkimus Oy Seinajoki Finland
Kinderarztpraxis Dr Kaiser – Dr. Marinesse Hamburg Germany
Rokotetutkimuskeskus Finvac Oy Tampere Finland
Instituto Hispalense De Pediatria S.L. Sevilla Spain

Other Sites

Site Name City Country Status
Hospital Quironsalud Barcelona Barcelona Spain
Hospital Universitario Hm Puerta Del Sur Mostoles Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Kinderpneumologische Praxis Dr. Funck Neuss Germany
Kinderarzt Dr Andreas Petri Hürth Germany
Praxis für Kinder und Jugendliche R Köllges Moenchengladbach Germany
FVR Suomen rokotetutkimus Oy Kokkola Finland
FVR Suomen rokotetutkimus Oy Tampere Finland
Fyf Sbmlex ruefpjyiwaauem Oc Jarvenpaa Finland
Fhc Sjuztk rrnhgcdzhgmkva Ot Turku Finland
Kqvchmtyguemyesn Dat mvbn Mkdodbc Hmon Schonau Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not recruiting
15.05.2024
Germany Germany
Not recruiting
15.05.2024
Spain Spain
Not recruiting
15.05.2024

Trial locations

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.

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.

Trial ID:
2023-505762-29-00
Protocol code:
VAD00004
Trial Phase:
Therapeutic confirmatory (Phase III)

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