Evaluating the Benefits Of RSV MaternaL vAccination Using a Scottish National Dataset.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 1
- 主要终点
- PCR-confirmed RSV-associated LRTD hospitalization occurring ≤180 days after birth (first episode)
研究概览
简要总结
This study will use a retrospective cohort design and will be conducted within routinely collected national healthcare and statutory demographic datasets held by PHS and National Records of Scotland (NRS). As such, there will be no active enrollment of study participants, no direct contact with study participants, no collection of any primary data outside of the standard of care (SOC), and no requirement for informed consent.
This study design was chosen due to several advantages, over other possible designs, including the ability to evaluate incidence of study outcomes in exposed and unexposed infants, ability to follow infants longitudinally to evaluate study outcomes through 12 months of age, and ability to evaluate all-cause outcomes.
Study endpoints, including RSV-associated LRTD hospitalization and RSV-associated hospitalization, among infants born to ABRYSVO-vaccinated mothers (exposed group) will be compared with those among infants born to ABRYSVO-unvaccinated mothers (comparison group) initially from birth through 6 months of age, with later analysis from birth through 12 months as the infants reach this age threshold and their data become available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •to be eligible for inclusion in the study:
- •Live birth in Scotland from 1st September 2024 to 28th February 2026
- •Gestational age at birth ≥28(0/7) weeks of gestation (earliest gestational age eligible for ABRYSVO vaccination)
- •Infants meeting any of the following criteria will not be included in the study:
- •Born to a mother who received any licensed or investigational RSV vaccine other than ABRYSVO at any time during pregnancy
- •Meets UK national guidelines for monoclonal antibody receipt
排除标准
- 未提供
研究组 & 干预措施
Unexposed
Infants born to mothers who did not receive ABRYSVO during pregnancy will be considered unexposed
Exposed
Infants whose mother received ABRYSVO vaccine during pregnancy 14 days or more before delivery
干预措施: ABRYSVO (Biological)
结局指标
主要结局
PCR-confirmed RSV-associated LRTD hospitalization occurring ≤180 days after birth (first episode)
时间窗: ≤180 days after birth
次要结局
- PCR-confirmed RSV-associated hospitalization occurring ≤180 days after birth (first episode)(≤180 days after birth)
- PCR-confirmed RSV-associated LRTD hospitalization occurring ≤180 days after birth (first episode) stratified by term/preterm status and by gestational age at vaccination(≤180 days after birth)
- PCR-confirmed RSV-associated hospitalization occurring ≤180 days after birth (first episode) stratified by term/preterm status at delivery and by gestational age at vaccination(≤180 days after birth)
- PCR-confirmed RSV-associated LRTD hospitalization occurring ≤360 days after birth (first episode) (by cumulative and by discrete age-intervals)(≤360 days after birth)
- PCR-confirmed RSV-associated hospitalization occurring ≤360 days after birth (first episode) (by cumulative and by discrete age-intervals)(≤360 days after birth)
- LRTI hospitalization (any cause) occurring ≤360 days after birth (first episode during the RSV season) (cumulative and by age-intervals)(≤360 days after birth)
- ARI hospitalization (any cause) occurring ≤360 days after birth (first episode during the RSV season) (cumulative and by age-intervals)(≤360 days after birth)