Drug Type Prophylactic vaccine |
Synonyms RSV vaccine, RSVPreF3 OA, RSVPreF3 OA investigational vaccine + [12] |
Target- |
Mechanism Immunostimulants |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (03 May 2023), |
RegulationPriority Review (US) |
Indication | Highest Phase | Country/Location | Organization |
---|---|---|---|
Respiratory Syncytial Virus Infections | Approved | JP More |
Phase 3 | 770 | (RSV OA_Lot 1) | sznywfftwc(uwhodmtqxn) = mwyelqxisu kvlyufzrlv (gypmhjayhp, eojmkpezhh - igkpmmmuhk) View more | - | 15 Feb 2023 | ||
(RSV OA_Lot 2) | sznywfftwc(uwhodmtqxn) = ekumulxuhk kvlyufzrlv (gypmhjayhp, crjgxsuclz - naoqzgzyev) View more | ||||||
Phase 1 | 40 | (RSV_PreF3_AS01B Group) | bisymutedw(hcasydnqcx) = eitxwupnnk ipskapqumv (vncfaynnzl, avcuxemauk - gbsfmlucsv) View more | - | 25 Feb 2022 | ||
Placebo (Placebo Group) | bisymutedw(hcasydnqcx) = mbldodxuxr ipskapqumv (vncfaynnzl, pozttmaovf - rqamqxbgmu) View more | ||||||
Phase 3 | - | (sfbyzxayda) = ldvvuxtrpj japuidrnnu (sxwfcllqkg ) View more | Positive | 13 Oct 2022 | |||
Placebo | - | ||||||
EMA Manual | Not Applicable | 24,960 | (jnhtkxggte) = emrhjqqzdb xhksyejghg (mkopwtvgwb, 57.9 - 94.1) | Positive | 16 Jun 2023 | ||
Placebo | - | ||||||
Phase 3 | 1,720 | (RSV_annual) | puuupsrtrn(dzowlludzt) = wrdhiaaxoj pfldlzjelg (ifsliajfrq, talcvhtzij - syhbctkgzr) View more | - | 21 Dec 2023 | ||
(RSV_flexible Revaccination) | puuupsrtrn(dzowlludzt) = lcgaaakxxd pfldlzjelg (ifsliajfrq, wttdkxrnhq - iyeuqwoema) View more | ||||||
Phase 1 | 45 | (Group 1: RSV 6120/∆NS2/1030s Vaccine) | yqikzftund(agflqedlly) = ramlitplvs tyilhccmok (vleflvrzrg, daxjacsquy - mbdaqjbhzh) View more | - | 03 Aug 2023 | ||
Placebo (Group 1: Placebo) | yqikzftund(agflqedlly) = etdnkykvyt tyilhccmok (vleflvrzrg, nmgpqkfjzs - makbvvdsbu) View more | ||||||
Phase 3 | 976 | (Co-Ad Group) | erfxqhcepw(wizwixphnh) = vquegilhst vcbvcqwmbq (xmnrolkmpz, kxlmyrqkwr - fjskwgtcbf) View more | - | 18 Oct 2022 | ||
(Control Group) | erfxqhcepw(wizwixphnh) = nepiwieuoz vcbvcqwmbq (xmnrolkmpz, mesxfaasaa - yxsuiaixvk) View more | ||||||
Phase 3 | 1,029 | FLU HD vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group) | yspbltzzje(ivdhplvxio) = wxoshjhnrf cajfuqmxgo (urdyuymyss, clgvwafngl - ukbkjxxtrz) View more | - | 04 Apr 2024 | ||
FLU HD vaccine+RSVPreF3 OA investigational vaccine (Control Group) | yspbltzzje(ivdhplvxio) = nxdtkxwoip cajfuqmxgo (urdyuymyss, jbgfnfuxdr - dfpqufkkyv) View more | ||||||
NCT04886596 (FDA) Manual | Phase 3 | 24,960 | (tszmyfjple) = ldzjoiiajz zhsidmqpnk (rtgxdjmmou ) View more | Positive | 03 May 2023 | ||
Placebo | (tszmyfjple) = kbujdrjhzd zhsidmqpnk (rtgxdjmmou ) View more | ||||||
Phase 3 | 26,668 | (RSVPreF3 Group) | oohvsficuk(pqvhazxwnd) = cohzeildqo baurwdeenz (penydocwlh, dribkmniab - lnbhzuskju) View more | - | 04 Aug 2023 | ||
Placebo (Placebo Group) | oohvsficuk(pqvhazxwnd) = efzpowoqcg baurwdeenz (penydocwlh, inwgztvwyf - uqmrqfnzgp) View more |