Real-World Effectiveness of the Adjuvanted RSVPreF3 Vaccine in Adults ≥60 Years: A Pragmatic Randomized Trial (BronquiVal)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is the first occurrence of a hospitalisation for RSV-related RD (ICD-10 code for RSV infection as primary or secondary diagnosis position OR a relevant RD in any diagnose position AND RSV infection confirmed by laboratory test (Polymerase Chain Reaction, PCR or antigen) within 10 days prior to or up to 2 days after hospital admission.
研究概览
简要总结
To evaluate the effectiveness of the RSVPreF3 vaccine (Arexvy®, GSK) in reducing RSV-related respiratory disease (RD) hospitalisations among individuals aged ≥ 60 years in the Valencian Community in Spain.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants aged ≥ 60 years.
- •Participants resident of the Valencian Community.
- •Informed consent form has been signed and dated.
排除标准
- •Contraindication of the vaccine: hypersensitivity to any of the components of the vaccine.
- •Previous vaccination with any RSV vaccine.
- •Participation in any other clinical trial (including for Medicines and Treatments) during the study period.
- •The following individuals will be excluded from the study, as RSV vaccination is already recommended for these groups in the region: • Adults aged 60 years or older living in long-term care or nursing home facilities. • Individuals with a history of lung transplantation. • Individuals with a history of haematopoietic stem cell transplantation (bone marrow transplantation).
结局指标
主要结局
The primary endpoint of the study is the first occurrence of a hospitalisation for RSV-related RD (ICD-10 code for RSV infection as primary or secondary diagnosis position OR a relevant RD in any diagnose position AND RSV infection confirmed by laboratory test (Polymerase Chain Reaction, PCR or antigen) within 10 days prior to or up to 2 days after hospital admission.
The primary endpoint of the study is the first occurrence of a hospitalisation for RSV-related RD (ICD-10 code for RSV infection as primary or secondary diagnosis position OR a relevant RD in any diagnose position AND RSV infection confirmed by laboratory test (Polymerase Chain Reaction, PCR or antigen) within 10 days prior to or up to 2 days after hospital admission.
次要结局
- RSV-related LRTD hospitalisations.
- RSV-related MACE hospitalisations.
- RSV-related COPD/Asthma exacerbations hospitalisations
研究者
Dr Alejandro Orrico Sanchez
Scientific
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana