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.
Study Type
OBSERVATIONAL
Enrollment
2,400
Unnamed facility
Germany, Germany, Germany
Assessing the nirsevimab immunization rates among eligible infants in both cohorts
Descriptive analysis of nirsevimab immunization status (yes/no) will be performed using summary statistics, i.e., proportion of immunized infants among all enrolled infants per wave.
Time frame: Throughout Study (Approximatley 4 months)
Assessing the seasonal evolution of the nirsevimab immunization coverage rates among the two cohorts
Descriptive analysis of nirsevimab immunization status over time will be performed using summary statistics, i.e., proportion of immunized infants among all enrolled infants per wave.
Time frame: Throughout Study (Approximatley 4 months)
Assessing reasons for/against nirsevimab immunization
The analysis for any potential influencing factors will be based on descriptive analytics and complemented with bi-variate analytics where applicable
Time frame: Throughout Study (Approximately 4 months)
Assessing the nirsevimab immunization rates among subgroups
A descriptive analysis of immunization rates will be performed on subgroups such as: risk group (defined chronic condition or pre-term birth status), federal states and health insurance/Kassenärztliche Vereinigung, physician's association regions
Time frame: Throughout Study (Approximately 4 months)
Assessing the reliability of a demographic study
Assessing reliability based on randomly sampled parent population using Computer-Assisted Web Interview (CAWI)/ Computer-Assisted Telephone Interview (CATI)/ face-to-face interviews for estimating immunization rates in Germany
Time frame: Throughout the Study (Approximately 4 months)
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