Monitoring RSV immunization rates in German infants
Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants During Three RSV Seasons
Sanofi · NCT06824207
This study is looking to see how many infants in Germany are getting the new RSV shot called nirsevimab in its first year of use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sanofi (industry) |
| Drugs / interventions | nirsevimab |
| Locations | 1 site (Germany) |
| Trial ID | NCT06824207 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the immunization rates of nirsevimab, a monoclonal antibody for Respiratory Syncytial Virus (RSV), among infants in Germany during its first year of widespread implementation. Following a recommendation from the German Standing Committee on Vaccination, the study will gather data on the uptake of this preventive measure to evaluate its public health impact. By surveying parents of infants born during specific time frames, the study seeks to establish a timely monitoring system for RSV immunization rates.
Who should consider this trial
Good fit: Ideal candidates for this study are parents of infants born between April 2024 and March 2025 who reside in Germany.
Not a fit: Patients who have previously participated in the study during the current season will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the effectiveness of nirsevimab immunization in reducing severe RSV disease in infants.
How similar studies have performed: While this study focuses on monitoring immunization rates, similar approaches in other countries have successfully tracked vaccination uptake and its effects on public health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be a parent of an infant born between April 2024/25/26 and March 2025/26/27, respectively * Reside in Germany at the time of survey completion * Be at least 18 years old at the time of survey completion. * Agree with privacy policy and AE (Adverse Event) reporting requirements before proceeding with the survey. * Read and agree to the ICF (Informed Consent Form) by ticking a box before proceeding with the survey. Exclusion Criteria: * Participation in the study (= completed the survey) in a previous wave of the current season. Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Where this trial is running
Germany
- Germany, Germany (RECRUITING)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Syncytial Virus Immunization, RSV, RSV Immunization Rates, Nirsevimab