Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
3期
进行中（已停止招募）
NCT04732871
| 适应症 | Respiratory Syncytial Virus Infections |
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| 分期 | 3期 |
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| 申办方 | GlaxoSmithKline |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 1,720 人 |
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| 干预（药物） | RSVPreF3 OA investigational vaccine |
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| 开始日期 | 2021年2月15日 |
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| 完成日期 | 2022年6月6日 |
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| 结果公布日 | 2023年12月21日 |
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摘要
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1
At Day 1 · Titers (ED60)
| RSV_annual | 832.4 Titers (ED60) |
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| RSV_flexible Revaccination | 864.9 Titers (ED60) |
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| RSV_1dose | 896.8 Titers (ED60) |
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Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31
At Day 31 · Titers (ED60)
| RSV_annual | 8827.2 Titers (ED60) |
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| RSV_flexible Revaccination | 8906.6 Titers (ED60) |
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| RSV_1dose | 9585.6 Titers (ED60) |
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Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6
At Month 6 · Titers (ED60)
| RSV_annual | 3465.2 Titers (ED60) |
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| RSV_flexible Revaccination | 3600.1 Titers (ED60) |
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| RSV_1dose | 4223.1 Titers (ED60) |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。