Drugs / RSVPreF3 OA
RSVPreF3 OA
Trials 12
News releases announcing trial results or a regulatory action · 13
| 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 ↗
Robust and Consistent Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) Across Different Age Ranges and Frailty Status in Older Adults |
| 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. |
| 2023-02-15 | GlaxoSmithKline | Results Landmark New England Journal of Medicine publication reinforces potential of GSK’s respiratory syncytial virus older adult vaccine candidate gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the publication of positive phase III trial results for its respiratory syncytial virus (RSV) older adult vaccine candidate in the New England Journal of Medicine. |
| 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. |
| 2022-10-28 | GlaxoSmithKline | Regulatory GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) 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 ↗
GSK plc (LSE/NYSE: GSK) today announced positive pivotal phase III trial results for its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above to be presented at IDWeek 2022. |
| 2022-10-12 | GlaxoSmithKline | Results GSK to present updates on its industry-leading infectious disease portfolio at IDWeek 2022 gsk.com ↗
A Respiratory Syncytial Virus (RSV) Prefusion F Protein Candidate Vaccine (RSVPreF3 OA) is Efficacious in Adults ≥ 60 Years of Age (YOA) |
| 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 ↗
After vaccination, a robust RSVPreF3 CD4+ T-cells response in older adults had been boosted to reach a similar range than the one observed in younger adults, with significantly higher immune response in the groups who received the adjuvanted formulation. |
All press releases naming this drug 13 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RSVPreF3 OA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04732871 ↗ |
| Known as | adjuvanted RSVPreF3 | “the AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) was immunologically non-inferior at 1 month post-vaccination in...” PMID 41194599 ↗ Nov 20251“Co-administration of AS01E-adjuvanted respiratory syncytial virus vaccine (adjuvanted RSVPreF3)” PMID 42054374 ↗ Apr 2026 |
| Known as | GSK3844766A | “RSVPreF3 OA investigational vaccine (GSK3844766A)” NCT04657198 ↗ |
| Known as | Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccine | “Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccine” NCT05966090 ↗ |
| Known as | RSVPreF3 | “The AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) is approved for ≥60-year-olds and 50-59-year-olds at increased...” PMID 41757519 ↗ May 2026 |
| Modality | Vaccine | “adjuvanted vaccine against RSV” PMID 37699064 ↗ Feb 2024 |
| Route | Intramuscular | “RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm” NCT04657198 ↗ |