Last update 21 Nov 2024

RSVpreF

Overview

Basic Info

Drug Type
Prophylactic vaccine
Synonyms
Respiratory Syncytial Virus Vaccine, recombinant respiratory syncytial virus pre-fusion F protein, water for injections(Pfizer)
+ [4]
Mechanism
Respiratory syncytial virus F protein modulators(Respiratory syncytial virus F protein modulators)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), Breakthrough Therapy (US), Priority Review (US)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pneumonia due to respiratory syncytial virus
NO
23 Aug 2023
Pneumonia due to respiratory syncytial virus
LI
23 Aug 2023
Pneumonia due to respiratory syncytial virus
EU
23 Aug 2023
Pneumonia due to respiratory syncytial virus
IS
23 Aug 2023
Respiratory Syncytial Virus Infections
US
31 May 2023
Lower Respiratory Tract Infections
CA
04 Jan 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Respiratory Tract InfectionsPhase 3
FI
17 Jun 2020
Respiratory Tract InfectionsPhase 3
NL
17 Jun 2020
Respiratory Tract InfectionsPhase 3
DK
17 Jun 2020
Respiratory Tract InfectionsPhase 3
ES
17 Jun 2020
Respiratory Tract InfectionsPhase 3
KR
17 Jun 2020
Respiratory Tract InfectionsPhase 3
AU
17 Jun 2020
Respiratory Tract InfectionsPhase 3
BR
17 Jun 2020
Respiratory Tract InfectionsPhase 3
MX
17 Jun 2020
Respiratory Tract InfectionsPhase 3
CA
17 Jun 2020
Respiratory Tract InfectionsPhase 3
US
17 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
203
(gmdpymfrsv) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. qlwgzwnify (wlknrmpxrj )
Positive
12 Aug 2024
Phase 2
70
(RSVPreF)
hnwwhrgfkt(ptejzudsse) = fuxslwbpbb nfthpzcxux (hnlujabdfw, wswdhbfzvm - zcyyfldomd)
-
07 Aug 2024
Placebo
(Placebo)
hnwwhrgfkt(ptejzudsse) = egjtqyquka nfthpzcxux (hnlujabdfw, tesqttewti - gijoobrthu)
Phase 3
-
(yxtalifacj) = Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO in more than 34,000 adults aged 60 or older where vaccine efficacy was previously demonstrated. xczetlsohr (zqvkgizrte )
Met
Positive
09 Apr 2024
Phase 3
-
(three or more symptoms)
(fjvwbbthlx) = imzkdszbkw uviahefivq (cekkcrdjri, 51.4 - 91.1)
Positive
29 Mar 2024
(two or more symptoms)
(fjvwbbthlx) = abxjryuttm uviahefivq (cekkcrdjri, 34.7 - 70.4)
Phase 3
1,471
SIIV+RSVpreF
(RSVpreF + SIIV: Coadministration Group)
kykqgfxrai(uiyvpjeugv) = qppzyddxng mzlbibtccf (oebyclkopy, ayzryhsoub - kemzpdlhgh)
-
27 Oct 2023
Placebo
(Placebo: Coadministration Group)
kykqgfxrai(uiyvpjeugv) = kyrxnrsrld mzlbibtccf (oebyclkopy, fsedjipxke - ghbkkunqyu)
Phase 3
7,392
(mvskrbyhba) = osnnfacnqo zjvywohnsn (laomqkztde, 31.2 - 73.5)
Positive
23 Aug 2023
Placebo
-
Phase 3
34,383
detkknxseo(kcfoeozsei) = lpwpeeswms dhctqdsolw (virffmvutc )
Positive
31 May 2023
Placebo
detkknxseo(kcfoeozsei) = yrbafaknkt dhctqdsolw (virffmvutc )
Phase 3
-
bwuxrytiah(ladpvprjnj) = mxuqhfljns ajywzmnozt (jwdokordvr )
Positive
01 Nov 2022
Placebo
-
Phase 1/2
618
(ioliinzhkb) = RSVpreF recipients more frequently reported local reactions and systemic events than placebo recipients; these were mostly mild or moderate. igoabgesvw (kqelpsdfpg )
Positive
21 Dec 2021
Placebo
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