Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants
NCT ID: NCT06824207
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2400 participants
OBSERVATIONAL
2025-01-13
2026-05-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Catch-Up Cohort
Parents of infants born between April and September
No interventions assigned to this group
In-Season Cohort
Parents of infants born between October and March
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
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18 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Locations
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Germany, Germany, Germany
Countries
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Other Identifiers
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RSV00093
Identifier Type: -
Identifier Source: org_study_id
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