Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Phase 3
Active, not recruiting
NCT04732871
| Condition | Respiratory Syncytial Virus Infections |
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| Phase | Phase 3 |
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| Sponsor | GlaxoSmithKline |
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| Status | Active, not recruiting |
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| Enrollment | 1,720 participants |
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| Interventions | RSVPreF3 OA investigational vaccine |
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| Start date | Feb 15, 2021 |
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| Completion date | Jun 6, 2022 |
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| Results posted | Dec 21, 2023 |
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Summary
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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Open in BENITIONS
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