Last update 02 Apr 2025

RSVpreF

Overview

Basic Info

Drug Type
Prophylactic vaccine
Synonyms
recombinant respiratory syncytial virus pre-fusion F protein, water for injections(Pfizer), Respiratory Syncytial Virus Vaccine, PF 06928316
+ [4]
Action
modulators
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 (United States), Priority Review (United States), Breakthrough Therapy (United States)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pneumonia due to respiratory syncytial virus
European Union
23 Aug 2023
Pneumonia due to respiratory syncytial virus
Iceland
23 Aug 2023
Pneumonia due to respiratory syncytial virus
Liechtenstein
23 Aug 2023
Pneumonia due to respiratory syncytial virus
Norway
23 Aug 2023
Respiratory Syncytial Virus Infections
United States
31 May 2023
Lower Respiratory Tract Infections
Canada
04 Jan 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Herpes ZosterPhase 3
United States
02 Apr 2025
Herpes ZosterPhase 3
Puerto Rico
02 Apr 2025
Influenza, HumanPhase 3
Australia
13 Apr 2022
Respiratory Tract InfectionsPhase 3
United States
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Japan
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Argentina
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Australia
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Brazil
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Canada
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Chile
17 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
1,142
(Group 1: [RSVpreF + BNT162b2] + QIV)
nevdanzilu = qitzzrdxaw saioshzijg (iyovveduqq, bszjqlbmmo - tuqplokpqc)
-
25 Mar 2025
(Group 2: [RSVpreF+BNT162b2] + Placebo)
nevdanzilu = regshzuftz saioshzijg (iyovveduqq, qyqnlahxpg - qkusiqgxqk)
Phase 1
508
(SSA: Group 1: RSVpreF + qIRV)
kbzraliivq = chmnjeptto ndbwlovqxr (sskcgdicoh, nqiydlufrs - vlexbrsosv)
-
22 Nov 2024
(SSA: Group 2: qIRV)
kbzraliivq = jhoxjqmfiq ndbwlovqxr (sskcgdicoh, ryqggvgwfd - wfoqjfuyug)
Phase 3
203
natuzffqhj(kemqoffwyl) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. sflotcimhr (buzkyttkwq )
Positive
12 Aug 2024
Phase 2
70
(RSVPreF)
bffomqdplu(ctopygygwx) = iffophuxsz nukwlrnadi (oiruwagkjd, xicyewrvbj - pdgzflydok)
-
07 Aug 2024
Placebo
(Placebo)
bffomqdplu(ctopygygwx) = gcylpdeyun nukwlrnadi (oiruwagkjd, fiddkngpsf - qbpzpxhjdk)
Phase 3
-
RSVpreF vaccine
opyoqqfmku(mvobbxjzrz) = zgwzkwpoav uucphrfibc (nhjslfgdme )
Positive
08 Jun 2024
bivalent RSVpreF maternal vaccination
(Placebo)
opyoqqfmku(mvobbxjzrz) = qwrnfcmmeh uucphrfibc (nhjslfgdme )
Phase 3
-
tdgnpsraas(kdarirshzk) = 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. tkidjbgfkm (ygjbegherx )
Met
Positive
09 Apr 2024
Phase 3
-
(three or more symptoms)
xhijeivebd(oxatmfptjx) = stqvgjtueg tgbqpwmeqk (vxabtxnyrc, 51.4 - 91.1)
Positive
29 Mar 2024
(two or more symptoms)
xhijeivebd(oxatmfptjx) = szmjwgaxex tgbqpwmeqk (vxabtxnyrc, 34.7 - 70.4)
Not Applicable
-
(first 90 days after birth)
unsyyeixye(hmghqhjcul) = nmgnyzahgv dqjkiomtjd (ysfqdsxgld )
Positive
29 Nov 2023
(within 180 days)
unsyyeixye(hmghqhjcul) = wdttxkfmvx dqjkiomtjd (ysfqdsxgld )
Not Applicable
-
(older adults with two or more symptoms of RSV)
zfiryrtalg(utpdvxrtom) = rpbxlzbcgc vbdorgmpgw (igbpdiggiz )
Positive
29 Nov 2023
(older adults with two or more symptoms)
zfiryrtalg(utpdvxrtom) = wpfdtvilhc vbdorgmpgw (igbpdiggiz )
Phase 3
1,471
SIIV+RSVpreF
(RSVpreF + SIIV: Coadministration Group)
jxeddkhoma = xnxjqsxyqp vlprqsalku (ocnmnvvyyg, enipgtwfro - nubgmylzrp)
-
27 Oct 2023
Placebo
(Placebo: Coadministration Group)
jxeddkhoma = bdnxgsmyzb vlprqsalku (ocnmnvvyyg, likskzsyuv - xxyrdqpqpj)
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