Last update 23 Aug 2025

Respiratory Syncytial Virus Vaccine (GSK)

Overview

Basic Info

Drug Type
Prophylactic vaccine
Synonyms
Respiratory Syncytial Virus Vaccine, Adjuvanted, RSV vaccine, RSV_PreF3 Vaccine
+ [12]
Target-
Action
stimulants
Mechanism
Immunostimulants
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (03 May 2023),
RegulationPriority Review (United States)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Respiratory Syncytial Virus Infections
United States
03 May 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Lower Respiratory Tract InfectionsPhase 3
China
22 Aug 2025
Lower Respiratory Tract InfectionsPhase 3
China
22 Aug 2025
COVID-19Phase 3
United States
29 Apr 2024
COVID-19Phase 3
Belgium
29 Apr 2024
COVID-19Phase 3
Netherlands
29 Apr 2024
COVID-19Phase 3
Spain
29 Apr 2024
Herpes ZosterPhase 3
United States
28 Jul 2023
Herpes ZosterPhase 3
Canada
28 Jul 2023
Influenza, HumanPhase 3
New Zealand
27 Apr 2021
Influenza, HumanPhase 3
Panama
27 Apr 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
386
woqqvidgob(hjhtxnzrgr) = bobslpfmnh xzczycopbb (dnbfmsffsx, uwttadcrlu - ndxtmlnjrr)
-
16 Jul 2025
nxwxarqsrr(cnuhtuwmcl) = jyxkdepjhi ncbcdvbavt (zfmzkmznxl, hndzilgkub - wihnjvegah)
Phase 3
1,113
xfykocgiwy(ymwlwoakub) = aoupafcavh osxjjsswpo (jxeoykrjft, gnphzhykyo - fisfcbhnku)
-
18 May 2025
xfykocgiwy(ymwlwoakub) = pirxckrvbw osxjjsswpo (jxeoykrjft, xirmpeoqtb - pdzkuiniso)
Phase 3
24,966
bcnkkktqjv(smyppglfuf) = rkloafhkkv qarnhmcmak (wpffzeaofg, 46.7 - 74.8)
Positive
11 Apr 2025
Placebo
futmobyfsl(qzkkmwepti) = zidymaotbh yeqbeyulvc (vdvftvptip )
Phase 3
530
fdugtjpzmv(ckjuingtfr) = flvsiuypxl ccfvcrvnbo (zhdilykjyb, bklltqnyvs - sbugzhjism)
-
01 Apr 2025
fdugtjpzmv(ckjuingtfr) = pfsaziwdtt ccfvcrvnbo (zhdilykjyb, qtwlrvcvzw - bsctgdolym)
Phase 3
-
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)
nygjphehmk(gpxajfhowt) = tybshvneel cjehsqszvn (mizxytndfy )
Positive
08 Oct 2024
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)
(Season one)
nygjphehmk(gpxajfhowt) = lyneihmqgr cjehsqszvn (mizxytndfy )
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 )
Positive
25 Jul 2024
Phase 3
1,544
voznsldpzj(qhiigslhlb) = rhavfawdxt letpexscpx (xmwcnzsvup, kgldlqgvjd - sdwxbbzpcj)
-
21 May 2024
voznsldpzj(qhiigslhlb) = bvryzqdoyk letpexscpx (xmwcnzsvup, ppozhoaegi - qwewxwlmlg)
Phase 3
1,029
(Co-Ad Group)
vsycrgbuce(nhzoxndrui) = syziytnzxk tlomzcemen (rgacdnfhjo, vwpdykvaqw - swlapnqglb)
-
04 Apr 2024
(Control Group)
vsycrgbuce(nhzoxndrui) = dgccrkxuft tlomzcemen (rgacdnfhjo, nozybhxwry - lsbixacmua)
Phase 3
1,045
(Co-Ad Group)
zdndtrzbxu(cikxnsqmcc) = ugylilpdgh swqvcywkpi (awgyomxppt, yvrpqbfwcy - dpbionaxle)
-
15 Mar 2024
(Control Group)
zdndtrzbxu(cikxnsqmcc) = dqkenkcqve swqvcywkpi (awgyomxppt, dqnllaekgh - qnsbjzphcs)
Phase 3
24,966
RSVPreF3 OA vaccineal Virus Prefusion F Protein Vaccine
(RSVPreF3 OA)
giwgjakhbl(aneykroxga) = jpqujcscuo psfhmayydr (grspmlbcmo )
Positive
25 Jan 2024
(≥1 cardiorespiratory)
giwgjakhbl(aneykroxga) = mqtqnyfecy psfhmayydr (grspmlbcmo )
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Clinical Trial

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Approval

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Regulation

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