Drugs / RSVpreF
RSVpreF
also known as
ABRYSVO · Pfizer Abrysvo · Pfizer RSV vaccine · Respiratory Syncytial Virus Prefusion F Vaccine · RSV prefusion F · RSV vaccine · RSVpreF vaccine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Abrysvo | — | 2023-08-23 | europa.eu ↗ |
Trials 27 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05900154 | Jun 2023 → Feb 2024 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05788237 | Mar → Sep 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT05886777 | Jun 2023 → Jan 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT04785612 | Nov 2020 → Apr 2021 | respiratory syncytial virus infectious disease | Hvivo | Completed | No outcome recorded |
| Phase 2 | NCT04071158 | Oct → Dec 2019 | respiratory tract infectious disorder | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT04032093 | Aug 2019 → Sep 2021 | respiratory tract infectious disorder | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03529773 | Apr 2018 → Nov 2019 | respiratory tract infectious disorder | Pfizer | Completed | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT07653100 | Jun 2026 → Jan 2027 expected | respiratory syncytial virus infectious disease | Pfizer | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07543380 | May → Aug 2026 overdue | respiratory syncytial virus infectious disease | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT07232706 | May 2026 → May 2029 expected | respiratory syncytial virus infectious disease | Centre Hospitalier Annecy Genevois | Recruiting | No outcome recorded |
| Phase 3 | NCT07041190 | Sep 2025 → Nov 2028 expected | respiratory syncytial virus infectious disease | PENTA Foundation | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06866405 | Apr 2025 → Feb 2028 expected | respiratory syncytial virus infectious disease | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT06890416 | Apr → Sep 2025 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT06593587 | Oct 2024 → Feb 2025 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT06473519 | Jun → Sep 2024 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT06325657 | Mar 2024 → Jun 2025 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT05842967 | May 2023 → Mar 2024 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT05301322 | Apr → Oct 2022 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT05096208 | Oct 2021 → Apr 2022 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT05035212 | Aug 2021 → Jan 2027 expected | lower respiratory tract disorder | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04424316 | Jun 2020 → Oct 2023 | respiratory tract infectious disorder | Pfizer | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT07693166 | Sep 2026 → Sep 2027 expected | HIV infectious disease, respiratory syncytial virus infectious disease | University of British Columbia | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07296120 | Jan 2026 → Jan 2027 expected | respiratory syncytial virus infectious disease | The Cooper Health System | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06684743 | Nov 2024 → May 2028 expected | respiratory syncytial virus infectious disease | Tor Biering-Sørensen | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06551506 | Sep 2024 → May 2026 | respiratory syncytial virus infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT06077149 | Nov 2023 → Nov 2024 | respiratory syncytial virus infectious disease | University of Rochester | Completed | No outcome recorded |
| Phase 4 | NCT05170399 | Sep 2022 → Aug 2026 overdue | lymphoma | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07492706 Comparator | Apr 2026 overdue | respiratory syncytial virus infectious disease | MAXVAX Biotechnology Limited Liability Company | Not yet recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07587801 Background | May → Jul 2026 overdue | — | Central Adelaide Local Health Network Incorporated | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06955728 Comparator | Sep 2025 → Feb 2028 expected | preterm premature rupture of the membranes, respiratory syncytial virus bronchiolitis | University of Witwatersrand, South Africa | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07097012 Comparator | Oct 2025 → Jul 2026 overdue | respiratory syncytial virus infectious disease | Canadian Immunization Research Network | Recruiting | No outcome recorded |
Press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-04-16 | Pfizer | ACIP Votes to Expand Recommendation for Pfizer’s RSV Vaccine ABRYSVO® to Include Adults Aged 50 to 59 at Increased Risk of Disease pfizer.com ↗ |
| 2025-04-01 | Pfizer | European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease pfizer.com ↗ |
| 2024-10-22 | Pfizer | U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease pfizer.com ↗ |
| 2024-08-12 | Pfizer | Pfizer Announces Top-Line Results of ABRYSVO® for RSV in Immunocompromised Adults pfizer.com ↗ |
| 2024-04-09 | Pfizer | Pfizer Announces Positive Top-Line Results from Phase 3 Study of ABRYSVO® in Adults Aged 18 to 59 at Increased Risk for RSV Disease pfizer.com ↗ |
| 2024-02-29 | Pfizer | Pfizer Announces Positive Top-Line Data for Full Season Two Efficacy of ABRYSVO® for RSV in Older Adults pfizer.com ↗ |
| 2023-09-22 | Pfizer | Pfizer Broadens Portfolio of Respiratory Vaccines Recommended by CDC Advisory Committee with ABRYSVO™ for RSV pfizer.com ↗ |
| 2023-08-24 | Pfizer | European Commission Approves Pfizer’s ABRYSVO™ to Help Protect Infants through Maternal Immunization and Older Adults from RSV pfizer.com ↗ |
| 2023-08-21 | Pfizer | U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age pfizer.com ↗ |
| 2023-05-31 | Pfizer | U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults pfizer.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RSVpreF | “The efficacy, immunogenicity, and safety of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine in pregnant women and their infants are uncertain.” PMID 35476650 ↗ Apr 202223“This phase 1/2 study evaluated a bivalent prefusion F vaccine (RSVpreF) with antigens from RSV subgroups A and B.” PMID 34932102 ↗ Apr 2022 “an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy” NCT06551506 ↗ “RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older” NCT06890416 ↗ “The RSVpreF vaccine will be administered according to the Product Monograph.” NCT07097012 ↗ “RSV stabilized prefusion F subunit vaccine (RSVpreF)” PMID 34637519 ↗ Jun 2022 “Biological: RSVPreF” NCT04785612 ↗ |
| Known as | ABRYSVO | “Cohort 2- Pregnant participants who received the RSVpreF in a previous pregnancy, either through commercial means with Abrysvo® or as part of a Pfizer clinical trial, will be...” NCT06866405 ↗10“All participants will get either the Pfizer RSV vaccine (RSVpreF (ABRYSVO)) or the GSK RSV vaccine (RSVpreF (AREXVY)) at 120 ug of the RSV prefusion F antigen intramuscularly...” NCT06077149 ↗ “Participants will receive a single dose of the RSVpreF vaccine (Abrysvo®) intramuscularly between 32+0 and 36+6 weeks of gestation, consistent with Health Canada approval.” NCT07693166 ↗ “an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy” NCT06551506 ↗ “For this arm, the RSV prefusion F protein-based vaccine Abrysvo® will be used” NCT06684743 ↗ “ABRYSVO vaccine developed by Pfizer.” NCT06955728 ↗ |
| Known as | Pfizer Abrysvo | “RSV vaccine (Pfizer Abrysvo)” NCT07587801 ↗ |
| Known as | Pfizer RSV vaccine | “All participants will get either the Pfizer RSV vaccine (RSVpreF (ABRYSVO)) or the GSK RSV vaccine (RSVpreF (AREXVY)) at 120 ug of the RSV prefusion F antigen intramuscularly...” NCT06077149 ↗ |
| Known as | Respiratory Syncytial Virus Prefusion F Vaccine | “Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)” NCT07296120 ↗ |
| Known as | RSV prefusion F | “RSV prefusion F (RSVpreF) is a bivalent stabilized prefusion F vaccine containing RSV-A and RSV-B antigens.” PMID 39928572 ↗ Feb 2026 |
| Known as | RSV vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07587801 ↗ |
| Known as | RSVpreF vaccine | “The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine.” NCT06325657 ↗ |
| Modality | Vaccine | “This phase 1/2 study evaluated a bivalent prefusion F vaccine (RSVpreF) with antigens from RSV subgroups A and B.” PMID 34932102 ↗ Apr 2022 |
| Route | Intramuscular | “single intramuscular injection” PMID 37018474 ↗ Apr 2023 |