Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants During Three RSV Seasons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Assessing the nirsevimab immunization rates among eligible infants in both cohorts
研究概览
简要总结
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:
- Assessing the immunization rates among eligible infants (according to STIKO recommendation) in their first RSV-season in Germany (i.e. across all geographies)
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
In-Season Cohort
Parents of infants born between October and March
Catch-Up Cohort
Parents of infants born between April and September
结局指标
主要结局
Assessing the nirsevimab immunization rates among eligible infants in both cohorts
时间窗: 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.
次要结局
- Assessing the seasonal evolution of the nirsevimab immunization coverage rates among the two cohorts(Throughout Study (Approximatley 4 months))
- Assessing reasons for/against nirsevimab immunization(Throughout Study (Approximately 4 months))
- Assessing the nirsevimab immunization rates among subgroups(Throughout Study (Approximately 4 months))
- Assessing the reliability of a demographic study(Throughout the Study (Approximately 4 months))