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

Recruiting

• Conditions: Respiratory Syncytial Virus Immunization

• Registration Number: NCT06824207
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-13
• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-04-25
• Study Completion: 2025-04-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessing the nirsevimab immunization rates among eligible infants in both cohorts	Throughout Study (Approximatley 4 months)	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.

Secondary Outcome Measures

Name	Time	Method
Assessing the seasonal evolution of the nirsevimab immunization coverage rates among the two cohorts	Throughout Study (Approximatley 4 months)	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.
Assessing reasons for/against nirsevimab immunization	Throughout Study (Approximately 4 months)	The analysis for any potential influencing factors will be based on descriptive analytics and complemented with bi-variate analytics where applicable
Assessing the nirsevimab immunization rates among subgroups	Throughout Study (Approximately 4 months)	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
Assessing the reliability of a demographic study	Throughout the Study (Approximately 4 months)	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