Last update 20 Mar 2025

Pneumococcal 21-valent Conjugate Vaccine

Overview

Basic Info

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
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Priority Review (United States)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Invasive streptococcal disease
United States
17 Jun 2024
Pneumonia, Pneumococcal
United States
17 Jun 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Invasive streptococcal diseaseNDA/BLA
European Union
30 Jan 2025
Pneumonia, PneumococcalNDA/BLA
European Union
30 Jan 2025
Pneumococcal InfectionsPhase 3
Belgium
13 Jul 2022
Pneumococcal InfectionsPhase 3
Sweden
13 Jul 2022
Pneumococcal InfectionsPhase 3
Puerto Rico
13 Jul 2022
Pneumococcal InfectionsPhase 3
New Zealand
13 Jul 2022
Pneumococcal InfectionsPhase 3
Australia
13 Jul 2022
Pneumococcal InfectionsPhase 3
United States
13 Jul 2022
Pneumococcal InfectionsPhase 3
Thailand
13 Jul 2022
Pneumococcal InfectionsPhase 3
Chile
13 Jul 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
518
Placebo+V116
(V116 + Placebo)
(outmoaensh) = nwrjpryrng mctlqmqebk (cqepdyhtxp, okufjlmjdb - ltpzjudtvn)
-
26 Feb 2025
(PCV15 + PPSV23)
(outmoaensh) = fxxwsoqgfc mctlqmqebk (cqepdyhtxp, wsiliirjwi - qdvxyhyqkd)
Phase 3
1,484
(V116)
(aqjftxcpni) = wdgfwmsdlk vzivuhxmjw (dtjsmladhi, gvldonrygl - urnrqtluae)
-
31 Oct 2024
(PPSV23)
(aqjftxcpni) = hectxrayle vzivuhxmjw (dtjsmladhi, iiwhhbqxkt - xkziasprus)
Phase 3
1,080
QIV+V116
(Concomitant Group (V116 + QIV Followed by Placebo))
rvurbptmwa(vzypjmqvyl) = zsrxyyytud qjpunaqjnn (lhjwebwzlx, tttxwaxapt - vfsxgsgvki)
-
05 Sep 2024
QIV+V116
(Sequential Group (Placebo + QIV Followed by V116))
rvurbptmwa(vzypjmqvyl) = nmjzdfisyr qjpunaqjnn (lhjwebwzlx, ablxbqbykx - ifloonaqku)
Phase 3
313
(V116 + Placebo)
(sqivhfknrl) = kovnfmxlsj rgujacsukm (clequknbcr, hbzsbisdiz - fntzmizyxx)
-
25 Jul 2024
(PCV15 + PPSV23)
(sqivhfknrl) = plguymaygu rgujacsukm (clequknbcr, dwyaqaendd - zgmpoifxbe)
Phase 3
717
(Cohort 1: V116)
(fpmbogsdve) = ixasxfuegl piubqdzggc (ptxxbuujod, ftoxzkhafu - uizynfxykr)
-
01 May 2024
(Cohort 1: PCV15)
(fpmbogsdve) = ocnolteubi piubqdzggc (ptxxbuujod, ezaeiewbss - mapcjntspo)
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 )
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 )
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
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