Active not recruitingOBSERVATIONAL

Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants

This study focuses on a new way to help protect babies in Germany from a common winter illness called Respiratory Syncytial Virus (RSV). RSV can make babies very poorly. This new protection, called nirsevimab, was recommended for all newborns in Germany from late 2024. It’s like a shield that helps prevent severe RSV. This study wants to find out how many babies are actually receiving this important immunisation. Because it's a new rollout, there's no quick way to track this yet. By understanding how many parents are choosing this protection for their babies, doctors and health organisations can better plan for the future. The study will look at babies born at different times of the year, including those born just before and during the RSV season.

At a glance

Status

Active not recruiting

Sponsor

Sanofi Pasteur, a Sanofi Company

Enrolment target

2,400

Start

13 Jan 2025

Estimated completion

30 May 2026

Respiratory Syncytial Virus Immunization

What is this study about?

This study is happening in Germany and is looking at how many babies are getting a new type of protection against a common winter illness called Respiratory Syncytial Virus, or RSV. RSV can be quite serious for babies, sometimes leading to hospital stays. A new medication called nirsevimab acts like a shield, helping babies fight off severe RSV. This protection was recently recommended for all babies in Germany starting from the winter of 2024/2025.

Because this is the first time nirsevimab is being widely used for all babies, experts want to understand how many babies are actually receiving it. There isn't a quick way to track this nationwide yet, so this study aims to fill that gap. Knowing how many babies are protected will help health organisations see how well the new recommendation is working and plan for future health strategies.

The study will look at babies under one year old during the first few years this protection is available. They’ll specifically look at babies born at different times of the year: those born between April and September (who would get the protection in early autumn) and those born between October and March (who would get it shortly after birth). This helps gather a full picture of how many babies are receiving this important safeguard.

Key takeaways

This study is about how many German babies are getting new RSV protection.
RSV can be serious for babies; nirsevimab helps protect against severe illness.
Your survey answers will help health experts plan for future baby health.
Participation involves completing an online survey, not medical visits.
The study takes place in Germany and is for parents of babies born from April 2024.
Your contribution helps understand the rollout of an important new public health measure.

Who may be eligible?

To be part of this study, you need to be a parent of a baby born between April 2024 and March 2027. You must be living in Germany when you complete the survey. You also need to be at least 18 years old.

Before you can take part, you'll be asked to agree to the privacy policy and understand how any side effects would be reported. You'll also need to confirm you've read and agree to a consent form, usually by ticking a box.

You cannot take part in the study if you have already completed the survey for a previous wave in the current RSV season.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a parent of a baby born between April 2024 and March 2027?
Do you currently live in Germany?
Are you 18 years old or older?
Have you *not* already completed this survey for a previous season?

Answer every question to see your result.

What does participation involve?

This study involves completing a survey. It does not involve any hospital visits, medical assessments, taking new medication, or long-term follow-up from researchers. You will only complete the survey once for the current season.

Potential risks and benefits

This study does not involve any medical interventions or treatments, so there are no direct medical risks to you or your baby. The main benefit is that your input will help health authorities understand how well the new RSV protection is being adopted, which can improve future public health strategies for babies. You are free to stop participating in the survey at any time without giving a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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City only
Germany, Germany

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that causes cold-like symptoms, but it can be more serious for babies and young children, sometimes leading to breathing difficulties.

What is nirsevimab?

Nirsevimab is a medicine that acts like a shield to protect babies from severe RSV. It helps their bodies fight off the virus if they catch it.

Why is this study important?

This study helps health experts understand how many babies are getting the new RSV protection. This information is key for planning health services and ensuring more babies are protected in the future.

Do I need to live in Germany to take part?

Yes, to participate in this study, you must be living in Germany when you complete the survey.

Will my baby receive any treatment if I join this study?

No, this study is about completing a survey. It does not involve any treatments, medications, or medical procedures for you or your baby.