NCT06824207

Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,400 (estimated)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In June 2024, the German Standing Committee on Vaccination (STIKO) recommended the universal immunization of infants with nirsevimab during their first RSV season. Nirsevimab is a long-acting monoclonal antibody designed to provide passive immunity against RSV, significantly reducing the risk of severe RSV disease in infants. This recommendation marks the 2024/25 season as the first in which nirsevimab is broadly implemented for all infants in Germany. Despite the introduction of this new prevention measure, there is currently no timely monitoring system for immunization rates. Understanding the uptake and coverage of nirsevimab is crucial for evaluating its impact on public health and guiding future vaccination strategies. Therefore, this study aims to monitor the national immunization rates of nirsevimab in children under one year of age during the initial seasons of its widespread use. The primary objective of this study is to determine the Nirsevimab immunization rate in eligible infants in their first RSV-season in Germany. The study will focus on: 1. Assessing the immunization rates among eligible infants (according to STIKO recommendation) in their first RSV-season in Germany (i.e. across all geographies) 2. Assessing the immunisation rates among the "catch-up cohort", i.e. all infants born between April and September. For these infants, the STIKO recommends immunization with nirsevimab in early autumn. 3. Assessing the immunization rate among the "in-season cohort", i.e. all infants born during the RSV season between October and March. For these newborns, the STIKO recommends immunization with Nirsevimab shortly after birth, preferably during the second "well-baby visit" at the age of 3-10 days of life.

Conditions

• Respiratory Syncytial Virus Immunization

Timeline

• Start date: 2025-01-13
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2025-02-13
• Last updated: 2025-06-05

Locations

1 site across 1 country: Germany