Study of nirsevimab and RSV vaccine (Abrysvo) for prevention of respiratory syncytial virus infection in infants during their first year of life

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What is this study about?

This clinical trial focuses on preventing Respiratory Syncytial Virus (RSV) infections, bronchiolitis, and respiratory tract infections in infants. The study examines two different prevention approaches using Beyfortus (nirsevimab) and Abrysvo, which are medications given as injections into the muscle. RSV is a common virus that can cause serious breathing problems in babies, especially during their first year of life.

The purpose of this research is to determine whether giving both an RSV vaccine to pregnant mothers and nirsevimab to their babies at 4 months of age works better than giving only nirsevimab to infants during RSV season. The study will track how well these approaches protect babies from developing RSV-related breathing problems during their first year of life.

Participants will be divided into two groups. In one group, pregnant mothers will receive the Abrysvo vaccine between weeks 32 and 36 of pregnancy, and their babies will later receive Beyfortus at 4 months of age. In the other group, babies will receive only Beyfortus during the RSV season. The babies’ health will be monitored throughout their first year of life to check for any breathing problems or infections.

1 Initial vaccination during pregnancy

If selected for maternal vaccination, you will receive Abrysvo vaccine between weeks 32 and 36 (plus 6 days) of pregnancy

The vaccine is administered as an injection into the muscle

2 Birth and initial assessment

After birth, your infant will be evaluated for participation in the next phase of the study

Basic health measurements will be recorded

3 Infant protection against RSV

Your infant will receive nirsevimab (Beyfortus) as a single injection into the muscle

The injection will be given either at birth (if born during RSV season) or at the start of RSV season

Some infants will receive the injection at 4 months of age (plus or minus 1 month)

The dose will be either 50 mg or 100 mg, depending on your infant’s needs

4 Monitoring period

Your infant will be monitored for 12 months after birth

Testing will be needed if your infant shows signs of respiratory infection (runny nose, blocked nose, cough, wheeze, or breathing difficulties)

Tests will include nasal swabs to check for RSV (Respiratory Syncytial Virus)

Any hospital visits or medical care related to respiratory problems will be recorded

5 Safety monitoring

Throughout the study period, any serious health events will be documented

Regular health assessments will be conducted

Oxygen levels will be checked if your infant shows signs of respiratory problems

6 Study completion

The study will conclude after your infant reaches 12 months of age

Final health assessments will be performed

All collected data will be evaluated to assess the effectiveness of the vaccination strategy

Who Can Join the Study?

  • Must be a pregnant woman between 32 and 36 weeks plus 6 days of pregnancy
  • Must be over 18 years of age
  • Must have social security coverage or equivalent insurance
  • Must be able to read and complete questionnaires in French or English
  • Must be willing and able to follow all study requirements
  • Must provide written informed consent before joining the study (both mother and partner/co-parent when applicable)
  • Must agree to receive vaccination during pregnancy if assigned to that group
  • Must agree for their baby to receive nirsevimab (a protective antibody medicine for infants)
  • Must deliver a live baby if enrolled in the study
  • Must agree that their data can be used in analysis with related international research
  • Must be willing to comply with all study procedures and follow-up visits

Who Cannot Join the Study?

  • Infants who are not between 0-12 months of age
  • Infants with known allergies to any components of RSV vaccines (respiratory syncytial virus vaccines)
  • Babies with severe medical conditions or compromised immune systems
  • Infants who have received any other RSV prevention treatment in the past
  • Babies born before 32 weeks of pregnancy (premature births)
  • Infants with active respiratory infections at the time of enrollment
  • Babies whose mothers did not receive prenatal care between weeks 32-36 of pregnancy
  • Infants with known genetic disorders or birth defects affecting the respiratory system
  • Babies who have previously been hospitalized for respiratory problems
  • Infants participating in other clinical trials
  • Babies whose parents/guardians cannot commit to the full study duration
  • Infants with documented severe reactions to previous vaccinations

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Intercommunal Creteil Creteil France

Other Sites

Site Name City Country Status
Hopital Antoine Beclere Clamart France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nimes Nimes France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Les Hopitaux Nord-Ouest Villefranche sur Saône France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.09.2025

Trial locations

Nirsevimab is a preventive medication designed to protect infants against respiratory syncytial virus (RSV) infection. It’s a long-acting antibody that helps the immune system fight against RSV. It can be given to infants either seasonally or at around 4 months of age.

Abrysvo is a vaccine given to pregnant women to help protect their unborn babies against RSV. It works by helping the mother’s body create antibodies that can be passed to the baby before birth. The vaccine is administered during pregnancy between 32 and 36 weeks of gestation.

Investigated diseases:

Respiratory syncytial virus infection – A common viral infection that affects the respiratory tract, particularly in young children and infants. The virus causes inflammation and swelling of the small airways in the lungs. It typically starts with cold-like symptoms including runny nose and cough, which may progress to affect breathing. The infection often occurs seasonally and can spread easily through close contact.

Bronchiolitis – An inflammatory respiratory condition that affects the smallest air passages in the lungs called bronchioles. It causes swelling and mucus buildup in these tiny airways, making breathing difficult. The condition most commonly affects young children and infants. Symptoms typically begin with those similar to a common cold, such as congestion and cough, and may progress to rapid breathing and wheezing.

Respiratory tract infection – An infection that affects the respiratory system, which can involve the upper or lower airways or both. These infections can be caused by various viruses or bacteria affecting the nose, throat, sinuses, airways, or lungs. Common symptoms include cough, congestion, sore throat, and breathing changes. The infection may be accompanied by fever and general discomfort.

Trial ID:
2025-521755-23-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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