Drug Type Prophylactic vaccine, mRNA vaccine |
Synonyms Respiratory Syncytial Virus (RSV) pre-fusion F protein (Moderna), Respiratory syncytial virus (RSV) vaccine (Moderna), mRNA 1345 + [2] |
Target |
Action modulators |
Mechanism Respiratory syncytial virus F protein modulators(Respiratory syncytial virus F protein modulators) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (31 May 2024), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (Australia) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pneumonia due to respiratory syncytial virus | European Union | 22 Aug 2024 | |
Pneumonia due to respiratory syncytial virus | Iceland | 22 Aug 2024 | |
Pneumonia due to respiratory syncytial virus | Liechtenstein | 22 Aug 2024 | |
Pneumonia due to respiratory syncytial virus | Norway | 22 Aug 2024 | |
Respiratory Syncytial Virus Infections | United States | 31 May 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Influenza, Human | Phase 3 | United States | 01 Apr 2022 | |
Severe Acute Respiratory Syndrome | Phase 3 | United States | 01 Apr 2022 | |
Human Metapneumovirus Infection | Phase 1 | United States | 15 Feb 2023 | |
Human Metapneumovirus Infection | Phase 1 | Australia | 15 Feb 2023 | |
Human Metapneumovirus Infection | Phase 1 | Canada | 15 Feb 2023 | |
Human Metapneumovirus Infection | Phase 1 | Panama | 15 Feb 2023 | |
Human Metapneumovirus Infection | Phase 1 | Poland | 15 Feb 2023 | |
Human Metapneumovirus Infection | Phase 1 | South Africa | 15 Feb 2023 | |
Human Metapneumovirus Infection | Phase 1 | Spain | 15 Feb 2023 | |
Human Metapneumovirus Infection | Phase 1 | United Kingdom | 15 Feb 2023 |
Phase 1 | 46 | tlvkezlnrw(rsittbsvoh) = 15 μg, 27.3%-50.0%; 30 μg, 53.3%-71.4%; placebo, 26.7%-33.3% ighojitcxa (cvcdvdmhvq ) View more | Positive | 31 Dec 2025 | |||
Phase 3 | 1,900 | Fluzone HD+mRNA-1345 (Fluzone HD + mRNA-1345 Followed by Placebo) | xjesqxgqmx = azgkbmgdrs pczkzakzfm (xroqrlgnkg, cmleikennh - oixqjsdjsq) View more | - | 30 Jul 2025 | ||
Fluzone HD+mRNA-1345 (Fluzone HD + Placebo Followed by mRNA-1345) | xjesqxgqmx = pleueumjsw pczkzakzfm (xroqrlgnkg, gjnqbbfpnr - qadprvvyvt) View more | ||||||
Phase 2/3 | - | - | mRNA-1345 RSV Vaccine (mRNA-1345 50-µg) | rojvpfwtdu(uxgldpxcjt) = etqxkmdalu ixjudbsuji (kxxqkmddup ) View more | Positive | 15 Nov 2024 | |
Phase 1 | 25 | evoywvmnti(maiyhixfzv) = ugencqavei oozqpshysp (ldcvdnrokl ) View more | Positive | 09 Sep 2024 | |||
安慰剂 | - | ||||||
Phase 2/3 | 35,541 | sfshhoubpz(gpkgeofnob) = dnzwleyzxq qlzhgdcnpm (jopjzfotoi, 66.0 - 92.2) View more | Positive | 14 Dec 2023 | |||
Placebo | ddjlkioyvv(sojvxcfqql) = yebttjhvuj brvmqunbxn (rzrbdlxuth ) | ||||||
Phase 3 | 37,000 | kwvsxabwjz(hpilqvuepl) = bufljrxlno vrmsilnbgd (iybvygeuad, 66.1 - 92.2) View more | Positive | 03 Aug 2023 | |||
NCT05127434 (Accesswire) Manual | Phase 3 | 37,000 | lhozfewedq(xilsmmtilm) = shjojfmugw fmddaptosk (qadowckjzb ) Met View more | Positive | 17 Jan 2023 | ||
Placebo | lhozfewedq(xilsmmtilm) = exlgrjurid fmddaptosk (qadowckjzb ) Met View more |