Drugs / RSVPreF3
RSVPreF3
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT07712380 | Aug 2026 → May 2029 expected | cardiovascular disorder | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04126213 | Nov 2019 → Jul 2020 | respiratory syncytial virus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06593210 | Oct 2024 → Sep 2026 overdue | immunodeficiency disease, respiratory syncytial virus infectious disease | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05045144 | Oct 2021 → Jun 2022 | respiratory syncytial virus infectious disease | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT04841577 | Apr → Sep 2021 | respiratory syncytial virus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-10-24 | GlaxoSmithKline | Results New data for Arexvy, GSK’s respiratory syncytial virus vaccine, show potential to help protect a broader group of adults at increased risk for RSV disease gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions and in adults who are immunocompromised. |
| 2024-10-10 | GlaxoSmithKline | Results GSK and ViiV Healthcare to showcase advances across industry-leading infectious disease portfolio at IDWeek 2024 gsk.com ↗
Persistence of Immunogenicity and Safety of the Respiratory Syncytial Virus Prefusion F Protein Vaccine (RSVPreF3 OA) Administered to Adults 50–59 Years of Age (YOA) |
| 2023-10-10 | GlaxoSmithKline | Results GSK and ViiV Healthcare to present scientific advancements in their industry-leading infectious diseases portfolio at IDWeek 2023 gsk.com ↗
Efficacy of One Dose of the Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) Persists for 2 Seasons in Adults ≥ 60 Years of Age |
| 2023-04-27 | GlaxoSmithKline | Regulatory GSK’s respiratory syncytial virus older adult vaccine candidate gains positive European Medicines Agency CHMP opinion gsk.com ↗
This is the first time an RSV vaccine candidate for adults has gained a positive opinion, one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. |
| 2023-03-01 | GlaxoSmithKline | Regulatory US FDA Advisory Committee votes to support effectiveness and safety of GSK’s respiratory syncytial virus older adult vaccine candidate gsk.com ↗
The Committee voted unanimously 12-0 on effectiveness and 10-2 on safety. |
| 2022-11-02 | GlaxoSmithKline | Regulatory GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for its respiratory syncytial virus (RSV) older adult vaccine candidate. |
| 2022-10-21 | GlaxoSmithKline | Regulatory GSK regulatory submission accepted by Japanese regulator for respiratory syncytial virus older adult vaccine candidate gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that a new drug application for its respiratory syncytial virus (RSV) older adult vaccine candidate has been accepted for review by the Japanese Ministry of Health, Labour and Welfare (MHLW). |
| 2022-10-13 | GlaxoSmithKline | Results GSK’s older adult respiratory syncytial virus (RSV) vaccine candidate shows 94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6% in pivotal trial gsk.com ↗
The vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs. 40 of 12,494) against RSV lower respiratory tract disease (RSV-LRTD), meeting the trial’s primary endpoint. |
| 2022-10-12 | GlaxoSmithKline | Results GSK to present updates on its industry-leading infectious disease portfolio at IDWeek 2022 gsk.com ↗
This will include the first presentation of the results from the 25,000-participant pivotal AReSVi-006 phase III trial which is investigating the efficacy and safety of GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above. |
| 2022-06-10 | GlaxoSmithKline | Results GSK announces positive pivotal phase III data for its respiratory syncytial virus (RSV) vaccine candidate for older adults gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial. |
| 2020-10-21 | GlaxoSmithKline | Results GSK presents positive clinical data on maternal and older adults RSV candidate vaccines gsk.com ↗
GSK today announced that its Respiratory Syncytial Virus (RSV) candidate vaccines for maternal immunisation (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in Phase I/II clinical studies. |
All press releases naming this drug 11 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RSVPreF3 | “Patients at least 18 years of age will receive a single dose of adjuvanted RSV vaccine (RSVPreF3, Arexvy, GSK).” NCT06593210 ↗4“a maternal respiratory syncytial virus vaccine candidate (RSVPreF3) demonstrated an acceptable safety profile” PMID 36722147 ↗ Aug 2023 |
| Known as | adjuvanted respiratory syncytial virus PreFusion protein 3 (RSVPreF3) vaccine | “the adjuvanted recombinant zoster vaccine (RZV) or the adjuvanted respiratory syncytial virus PreFusion protein 3 (RSVPreF3) vaccine can attenuate the progression of coronary...” NCT07712380 ↗ |
| Known as | RSV prefusion protein F3 | “A single-dose investigational respiratory syncytial virus (RSV) vaccine, RSV prefusion protein F3 (RSVPreF3), was co-administered with a single-dose quadrivalent influenza...” PMID 38970327 ↗ Feb 2025 |
| Modality | Vaccine | “RSVPreF3 OA investigational vaccine” NCT04841577 ↗ |
| Route | Intramuscular | “administered intramuscularly” NCT04126213 ↗ |