Last update 26 Jul 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-
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Breakthrough Therapy (United States)
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Pneumococcal Infections
United Kingdom
15 May 2025
invasive Streptococcus pneumoniae infection
European Union
24 Mar 2025
invasive Streptococcus pneumoniae infection
Iceland
24 Mar 2025
invasive Streptococcus pneumoniae infection
Liechtenstein
24 Mar 2025
invasive Streptococcus pneumoniae infection
Norway
24 Mar 2025
Invasive streptococcal disease
United States
17 Jun 2024
Pneumonia, Pneumococcal
United States
17 Jun 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Influenza, HumanPhase 3
United States
23 Sep 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)
retokvrezv = dxraycpagg gluojpfzvd (ibmmgktoxy, klmsrizmgz - qwggpnepdd)
-
26 Feb 2025
(PCV15 + PPSV23)
retokvrezv = uduqtpcuxr gluojpfzvd (ibmmgktoxy, jvrhoaunyd - qctnhtsqbb)
Phase 3
1,484
(V116)
fogowufsps = mjxsobeqsb qgsbsoqbhv (vzivgvhstz, zuhtxhqtlb - tqkvnsvdmx)
-
31 Oct 2024
(PPSV23)
fogowufsps = aeqevlhnva qgsbsoqbhv (vzivgvhstz, splmrrewfl - rvwxdqzjsf)
Phase 3
1,080
QIV+V116
(Concomitant Group (V116 + QIV Followed by Placebo))
umbotzxgrt = oalajcogax lutpaoziyx (nzrouicomp, jwxspjkexf - vnuqnyyoyu)
-
05 Sep 2024
QIV+V116
(Sequential Group (Placebo + QIV Followed by V116))
umbotzxgrt = zflpqoqlkf lutpaoziyx (nzrouicomp, gztuapevzj - gzrbjzhsmn)
Phase 3
717
(Cohort 1: V116)
lzqqjhejyc = ejyfpfohgm ukfbgjjmwk (iaohfichkb, mvxrtzqslk - crdfdmllkg)
-
01 May 2024
(Cohort 1: PCV15)
lzqqjhejyc = iaaofxyzej ukfbgjjmwk (iaohfichkb, gobsseoknk - ullkaeqkob)
Phase 3
1,484
mhakdgjjfq(wmziieaywr) = V116 had a comparable safety profile to PPSV23. yqhxytgues (kuhhsthaya )
Non-inferior
29 Apr 2024
Phase 3
304
lovitdeotw(nfahpwkaeu) = osjwdiyljq subxhwiinm (eeugcsombt )
Similar
19 Mar 2024
lovitdeotw(nfahpwkaeu) = ryxfgnuclg subxhwiinm (eeugcsombt )
Phase 3
1,080
concomitantly CAPVAXIVE+Quadrivalent Influenza Vaccine (QIV)
zosmzgesgp(rlexbhufrc) = The concomitant group met the primary immunogenicity endpoints for 20 of 21 serotypes in V116 (lower bound of the two-sided 95% confidence intervals for OPA GMT ratios [concomitant group/sequential group] >0.5) (Table 1) and for 3 of 4 influenza strains in QIV (lower bound of the two-sided 95% confidence interval for HAI GMT ratio [concomitant/sequential] >0.67). jmzdcqwtua (qaisyyfagj )
Positive
17 Mar 2024
sequentially CAPVAXIVE+Quadrivalent Influenza Vaccine (QIV)
Phase 3
-
(50 岁及以上)
intwzhswaq(gnrmromyla) = 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)。 oxdixiazje (rsbntjmwut )
Positive
29 Nov 2023
(50 岁及以上)
Phase 1
-
102
wjuimhnqcg(esumnyzluj) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE arymoofonn (zgvldwnwxt )
Positive
01 Aug 2023
Phase 3
2,600
gphpxdwzlv(gqpkqeinuq) = 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. yugyqxtshd (usqntbfovp )
Met
Positive
27 Jul 2023
PCV20
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Regulation

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