STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease hospitalisation among infants.
研究概览
简要总结
This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical encounters available in health records, supplemented with information from the official national immunisation registry, the Australian Immunisation Register. Additional data from accredited pathology laboratories will be included. There will be no active enrollment of study participants, no direct contact with study participants, and no collection of any primary data outside of the standard of care.
This study will use a test negative design to evaluate real-world vaccine effectiveness of RSVpreF vaccination during pregnancy against RSV-associated outcomes in infants.
详细描述
This case-control study using a test negative design will include all infants through 12 months of age who were admitted to one of the participating hospitals with symptoms of respiratory infection, met the clinical case definition of acute respiratory illness, and had a respiratory specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission with an RSV test result through standard of care testing.
The primary objective is to estimate vaccine effectiveness (VE) of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease (LRTD) hospitalisation among infants from birth through 6 months (0 to ≤180 days) of age.
Baseline characteristics of the study population will be described by case/control status and by maternal RSVpreF vaccination status. Standardised mean differences may be used to compare the distributions (absolute differences >0.10 will be considered meaningful). For all VE objectives, we will use a logistic regression model to compare the odds of maternal ABRYSVO vaccination during pregnancy between test-positive cases and test-negative controls, generating an odds ratio (OR) and 95% CI and we will use multivariable logistic regression to compute an adjusted OR (aOR), from which we will derive final VE estimates, adjusted for potential confounding, according to the formula: VE = (1-aOR) x 100%.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •Infant ≤12 months (≤360 days) of age on the hospitalisation date.
- •Index date within the time period for data collection (approximately 01 March 2025 - 28 February 2027)
- •Hospitalised with acute respiratory illness meeting the protocol-defined clinical case definition, and for whom RSV testing results from a specimen collected 10 days prior to hospital admission through 3 days after a hospital admission are known.
- •Infant born to a birth mother eligible to receive ABRYSVO vaccination, with infant date of birth on or after 17 February 2025.
排除标准
- •Participants meeting any of the following criteria will not be included in the study:
- •Infant born at <28 weeks and 0/7 days of gestational age.
- •Infant received any licensed or investigational RSV preventive product (e.g., palivizumab, nirsevimab, active RSV vaccine) since birth.
- •Infant received ≥1 blood transfusion or other blood products containing antibody (e.g., fresh frozen plasma) since birth.
- •Infant born to a birth mother who received any other licensed or investigational RSV vaccine during this pregnancy.
- •Infant born to a birth mother for whom ABRYSVO vaccination status cannot be confirmed in available data sources.
研究组 & 干预措施
Cases
Infants who meet the respiratory clinical case definition and test positive for RSV (result obtained from standard of care testing with specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission).
干预措施: ABRYSVO (Biological)
Controls
Infants who meet the respiratory clinical case definition and test negative for RSV (result obtained from standard of care testing with specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission).
干预措施: ABRYSVO (Biological)
结局指标
主要结局
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease hospitalisation among infants.
时间窗: From birth through 6 months (0 to ≤180 days) of age.
RSV-positive lower respiratory tract disease hospitalisation occurring 0 to ≤180 days after birth.
次要结局
- Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease hospitalisation among infants.(From birth through 6 months (0 to ≤180 days) of age within key subgroups.)
- Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive severe lower respiratory tract disease hospitalisation among infants.(From birth through 6 months (0 to ≤180 days) of age and within key subgroups.)
- Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive acute respiratory illness hospitalisation among infants.(From birth through 6 months (0 to ≤180 days) of age and within key subgroups.)