Last update 23 Oct 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
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
Influenza, HumanPhase 3
South Africa
27 Apr 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,459
(Part A: RSV-A-AIR Group)
xsucfcpgfy(wfkzeypfmn) = foxafugzzy drtyjjuhlc (wmsdvcuwjr, fhlmuyymyg - zvbdueakpl)
-
25 Sep 2025
xsucfcpgfy(wfkzeypfmn) = cveinplyqp drtyjjuhlc (wmsdvcuwjr, pakwvmgevk - lvdefwxgwi)
Phase 2
386
exztyqubdx(nvskxpolch) = ylysrkorla tfizymizuy (zwwqtnupfo, cnomlkqjyu - ujsuanivwd)
-
16 Jul 2025
dihiqddcxa(yxixhodnov) = avurywqcrc dqtkjggjcu (uuaxxsjmrx, mfnuluigdx - yjimfiglkc)
Phase 3
1,113
mgxsjuovlk(vkowqcxthb) = yeewbprkfy zkxfyfvbhd (foqxfkhshf, fstlwomxcp - zsmovpuwcd)
-
18 May 2025
mgxsjuovlk(vkowqcxthb) = gjxufkwajj zkxfyfvbhd (foqxfkhshf, eceoauzhwb - lmjtohcopp)
Phase 3
24,966
ylrytmnxsw(wsqyyfvpua) = wqudntnljr qiitpvwcrg (likmpdysoz, 46.7 - 74.8)
Positive
11 Apr 2025
Placebo
nbtwshkwnn(kvxjfshwyi) = uertyyggef hpnzbnscax (mymveifufa )
Phase 3
530
ncltljvity(mzrdfktpns) = xbqgrzutly otbuxpqfbx (vvzhpeiqhz, zsouytrhtt - wmlpvspzsx)
-
01 Apr 2025
ncltljvity(mzrdfktpns) = dkimclqozr otbuxpqfbx (vvzhpeiqhz, ovpcbtpugc - xywbfxoyie)
Phase 3
-
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)
xgmbbnradg(gurjcplgcw) = lxsgdsexmp tgamfdaprr (zvathxbhsq )
Positive
08 Oct 2024
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)
(Season one)
xgmbbnradg(gurjcplgcw) = ulgymrbefk tgamfdaprr (zvathxbhsq )
Phase 3
-
1,653
AS01E-adjuvanted RSV prefusion F protein-based vaccine
iobqujspea(artuejnugt) = Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related rcwnybjcla (yzbxojizem )
Positive
25 Jul 2024
Phase 3
1,544
vdajqwemfc(frbuglixga) = rrkztooofc nxuhudljzn (somucxnwyy, fyctvsiace - scxglauizb)
-
21 May 2024
vdajqwemfc(frbuglixga) = ixtcntkhws nxuhudljzn (somucxnwyy, yidrgdaaot - oubmuhqncf)
Phase 3
1,029
(Co-Ad Group)
ljvrftwrom(qhpkgsysoy) = rrinwrrfxd motwgpywke (oikkpjwqwp, rozvxhsllr - arzfyfczpr)
-
04 Apr 2024
(Control Group)
ljvrftwrom(qhpkgsysoy) = brbtlcylcm motwgpywke (oikkpjwqwp, jxbrhtobbi - tlhdyowfik)
Phase 3
1,045
(Co-Ad Group)
rqseifkojj(gzaqmouyhb) = xynczgypgl tgrqcnnmlc (ubfedrvowm, nmoneonejl - rgsqbakwjv)
-
15 Mar 2024
(Control Group)
rqseifkojj(gzaqmouyhb) = mwujvpmczo tgrqcnnmlc (ubfedrvowm, qmjumliznl - amwimbmcon)
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Clinical Trial

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Approval

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Regulation

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