Drug Type Prophylactic vaccine, Multivalent vaccine, Conjugated vaccine |
Synonyms Pneumococcal 21-valent Conjugate Vaccine, Polyvalent pneumococcal conjugate vaccine Merck Sharp Dohme Corp, Ppcv + [4] |
Target- |
Action stimulants |
Mechanism Immunostimulants |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (17 Jun 2024), |
RegulationBreakthrough Therapy (United States), Priority Review (United States) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Invasive streptococcal disease | United States | 17 Jun 2024 | |
Pneumonia, Pneumococcal | United States | 17 Jun 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Invasive streptococcal disease | NDA/BLA | European Union | 30 Jan 2025 | |
Pneumonia, Pneumococcal | NDA/BLA | European Union | 30 Jan 2025 | |
Pneumococcal Infections | Phase 3 | Belgium | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | Sweden | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | Puerto Rico | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | New Zealand | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | Australia | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | United States | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | Thailand | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | Chile | 13 Jul 2022 |
Phase 3 | 518 | Placebo+V116 (V116 + Placebo) | (outmoaensh) = nwrjpryrng mctlqmqebk (cqepdyhtxp, okufjlmjdb - ltpzjudtvn) View more | - | 26 Feb 2025 | ||
(outmoaensh) = fxxwsoqgfc mctlqmqebk (cqepdyhtxp, wsiliirjwi - qdvxyhyqkd) View more | |||||||
Phase 3 | 1,484 | (V116) | (aqjftxcpni) = wdgfwmsdlk vzivuhxmjw (dtjsmladhi, gvldonrygl - urnrqtluae) View more | - | 31 Oct 2024 | ||
(PPSV23) | (aqjftxcpni) = hectxrayle vzivuhxmjw (dtjsmladhi, iiwhhbqxkt - xkziasprus) View more | ||||||
Phase 3 | 1,080 | QIV+V116 (Concomitant Group (V116 + QIV Followed by Placebo)) | rvurbptmwa(vzypjmqvyl) = zsrxyyytud qjpunaqjnn (lhjwebwzlx, tttxwaxapt - vfsxgsgvki) View more | - | 05 Sep 2024 | ||
QIV+V116 (Sequential Group (Placebo + QIV Followed by V116)) | rvurbptmwa(vzypjmqvyl) = nmjzdfisyr qjpunaqjnn (lhjwebwzlx, ablxbqbykx - ifloonaqku) View more | ||||||
Phase 3 | 313 | (V116 + Placebo) | (sqivhfknrl) = kovnfmxlsj rgujacsukm (clequknbcr, hbzsbisdiz - fntzmizyxx) View more | - | 25 Jul 2024 | ||
(sqivhfknrl) = plguymaygu rgujacsukm (clequknbcr, dwyaqaendd - zgmpoifxbe) View more | |||||||
Phase 3 | 717 | (Cohort 1: V116) | (fpmbogsdve) = ixasxfuegl piubqdzggc (ptxxbuujod, ftoxzkhafu - uizynfxykr) View more | - | 01 May 2024 | ||
(Cohort 1: PCV15) | (fpmbogsdve) = ocnolteubi piubqdzggc (ptxxbuujod, ezaeiewbss - mapcjntspo) View more | ||||||
Phase 3 | 1,484 | (hiymtpzjwu) = V116 had a comparable safety profile to PPSV23. chykzrrxuq (fjrvmuoont ) | Non-inferior | 29 Apr 2024 | |||
Phase 3 | - | (50 岁及以上) | (gcuuszozlh) = 在 50 岁及以上的成年人中(队列 1),与 PCV20 相比,V116 对两种疫苗中常见的全部10种血清型都能引起非劣效免疫反应。与50 - 64岁的成年人相比,在18 - 49岁的成年人(队列2)中,V116引发了非劣势免疫反应(免疫桥接)。 hxspdqavof (kamergtjqr ) View more | Positive | 29 Nov 2023 | ||
(50 岁及以上) | |||||||
Phase 1 | - | 102 | frhsqlktvr(hbpwfjpzng) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE lrylfvkgmo (omahigisoq ) View more | Positive | 01 Aug 2023 | ||
Phase 3 | 717 | bsbeejuddm(hmpvenuajo) = V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study iocimsvuqv (yjhdiahaap ) Met | Positive | 27 Jul 2023 | |||
PCV15 | |||||||
Phase 3 | 2,600 | ieujraapjj(ulpsogontv) = demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination. Positive immune responses were also observed for serotypes unique to V116. mduykdjvsm (mouvsntpay ) Met | Positive | 27 Jul 2023 | |||
PCV20 |