Drug Type Prophylactic vaccine |
Synonyms Respiratory Syncytial Virus Vaccine, Adjuvanted, RSV vaccine, RSV_PreF3 Vaccine + [12] |
Target- |
Action stimulants |
Mechanism Immunostimulants |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (03 May 2023), |
RegulationPriority Review (United States) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Respiratory Syncytial Virus Infections | United States | 03 May 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Lower Respiratory Tract Infections | Phase 3 | China | 22 Aug 2025 | |
Lower Respiratory Tract Infections | Phase 3 | China | 22 Aug 2025 | |
COVID-19 | Phase 3 | United States | 29 Apr 2024 | |
COVID-19 | Phase 3 | Belgium | 29 Apr 2024 | |
COVID-19 | Phase 3 | Netherlands | 29 Apr 2024 | |
COVID-19 | Phase 3 | Spain | 29 Apr 2024 | |
Herpes Zoster | Phase 3 | United States | 28 Jul 2023 | |
Herpes Zoster | Phase 3 | Canada | 28 Jul 2023 | |
Influenza, Human | Phase 3 | New Zealand | 27 Apr 2021 | |
Influenza, Human | Phase 3 | Panama | 27 Apr 2021 |
Phase 2 | 386 | (RSV_IC_2 Group) | woqqvidgob(hjhtxnzrgr) = bobslpfmnh xzczycopbb (dnbfmsffsx, uwttadcrlu - ndxtmlnjrr) View more | - | 16 Jul 2025 | ||
(RSV_IC_1 Group) | nxwxarqsrr(cnuhtuwmcl) = jyxkdepjhi ncbcdvbavt (zfmzkmznxl, hndzilgkub - wihnjvegah) View more | ||||||
Phase 3 | 1,113 | (Co-administration Group) | xfykocgiwy(ymwlwoakub) = aoupafcavh osxjjsswpo (jxeoykrjft, gnphzhykyo - fisfcbhnku) View more | - | 18 May 2025 | ||
(Control Group) | xfykocgiwy(ymwlwoakub) = pirxckrvbw osxjjsswpo (jxeoykrjft, xirmpeoqtb - pdzkuiniso) View more | ||||||
Phase 3 | 24,966 | bcnkkktqjv(smyppglfuf) = rkloafhkkv qarnhmcmak (wpffzeaofg, 46.7 - 74.8) View more | Positive | 11 Apr 2025 | |||
Placebo | futmobyfsl(qzkkmwepti) = zidymaotbh yeqbeyulvc (vdvftvptip ) | ||||||
Phase 3 | 530 | (Co-administration Group) | fdugtjpzmv(ckjuingtfr) = flvsiuypxl ccfvcrvnbo (zhdilykjyb, bklltqnyvs - sbugzhjism) View more | - | 01 Apr 2025 | ||
(Control Group) | fdugtjpzmv(ckjuingtfr) = pfsaziwdtt ccfvcrvnbo (zhdilykjyb, qtwlrvcvzw - bsctgdolym) View more | ||||||
Phase 3 | - | Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) | nygjphehmk(gpxajfhowt) = tybshvneel cjehsqszvn (mizxytndfy ) View more | Positive | 08 Oct 2024 | ||
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) (Season one) | nygjphehmk(gpxajfhowt) = lyneihmqgr cjehsqszvn (mizxytndfy ) View more | ||||||
Phase 3 | - | 1,653 | AS01E-adjuvanted RSV prefusion F protein-based vaccine | zntpcjuaut(scikkdfkft) = Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related vetszglnjq (drcsyhbzat ) View more | Positive | 25 Jul 2024 | |
Phase 3 | 1,544 | (Adults HA-RSV Group) | voznsldpzj(qhiigslhlb) = rhavfawdxt letpexscpx (xmwcnzsvup, kgldlqgvjd - sdwxbbzpcj) View more | - | 21 May 2024 | ||
(OA-RSV Group) | voznsldpzj(qhiigslhlb) = bvryzqdoyk letpexscpx (xmwcnzsvup, ppozhoaegi - qwewxwlmlg) View more | ||||||
Phase 3 | 1,029 | FLU HD vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group) | vsycrgbuce(nhzoxndrui) = syziytnzxk tlomzcemen (rgacdnfhjo, vwpdykvaqw - swlapnqglb) View more | - | 04 Apr 2024 | ||
FLU HD vaccine+RSVPreF3 OA investigational vaccine (Control Group) | vsycrgbuce(nhzoxndrui) = dgccrkxuft tlomzcemen (rgacdnfhjo, nozybhxwry - lsbixacmua) View more | ||||||
Phase 3 | 1,045 | FLU vaccine+RSVPreF3 OA vaccine (Co-Ad Group) | zdndtrzbxu(cikxnsqmcc) = ugylilpdgh swqvcywkpi (awgyomxppt, yvrpqbfwcy - dpbionaxle) View more | - | 15 Mar 2024 | ||
FLU vaccine+RSVPreF3 OA vaccine (Control Group) | zdndtrzbxu(cikxnsqmcc) = dqkenkcqve swqvcywkpi (awgyomxppt, dqnllaekgh - qnsbjzphcs) View more | ||||||
NCT04886596 (Pubmed) Manual | Phase 3 | 24,966 | RSVPreF3 OA vaccineal Virus Prefusion F Protein Vaccine (RSVPreF3 OA) | giwgjakhbl(aneykroxga) = jpqujcscuo psfhmayydr (grspmlbcmo ) View more | Positive | 25 Jan 2024 | |
(≥1 cardiorespiratory) | giwgjakhbl(aneykroxga) = mqtqnyfecy psfhmayydr (grspmlbcmo ) View more |