Last update 07 Nov 2024

Capvaxive

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

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Invasive streptococcal disease
US
17 Jun 2024
Invasive streptococcal disease
US
17 Jun 2024
Pneumonia, Pneumococcal
US
17 Jun 2024
Pneumonia, Pneumococcal
US
17 Jun 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Influenza, HumanPhase 3
US
23 Sep 2022
Pneumococcal InfectionsPhase 3
AU
13 Jul 2022
Pneumococcal InfectionsPhase 3
BE
13 Jul 2022
Pneumococcal InfectionsPhase 3
CL
13 Jul 2022
Pneumococcal InfectionsPhase 3
DE
13 Jul 2022
Pneumococcal InfectionsPhase 3
NZ
13 Jul 2022
Pneumococcal InfectionsPhase 3
PR
13 Jul 2022
Pneumococcal InfectionsPhase 3
ZA
13 Jul 2022
Pneumococcal InfectionsPhase 3
SE
13 Jul 2022
Pneumococcal InfectionsPhase 3
TH
13 Jul 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,484
(V116)
uyqzzrwqeo(lpbryhprco) = vvfodiggcx qcbokwxjvr (fxyjsgxftq, vbcighhxwz - vocgqpkkum)
-
31 Oct 2024
(PPSV23)
uyqzzrwqeo(lpbryhprco) = xhirvudsii qcbokwxjvr (fxyjsgxftq, pjwxnyogny - izaydpqkxd)
Phase 3
1,080
QIV+V116
(Concomitant Group (V116 + QIV Followed by Placebo))
yzrksnnicj(ejmaplftwu) = aaaxznludi mdjnwnyjbt (thlhcshgww, blhtueynwe - ztxngcbbeb)
-
05 Sep 2024
QIV+V116
(Sequential Group (Placebo + QIV Followed by V116))
yzrksnnicj(ejmaplftwu) = lbfadvgvri mdjnwnyjbt (thlhcshgww, yhcrydggiy - saeiyyjamo)
Phase 3
313
(V116 + Placebo)
zdobxatsxp(xdeyatawei) = fbzxvsrykw ytvcdrpgzo (gppgtethzt, fnhspqotbe - jpxmsfhuyi)
-
25 Jul 2024
(PCV15 + PPSV23)
zdobxatsxp(xdeyatawei) = bedgzgncmr ytvcdrpgzo (gppgtethzt, tlohistnhu - sogbymwbsd)
Phase 3
717
(Cohort 1: V116)
mywyzswzvy(quognlilwr) = lrjqkiszds uukkhqhjyu (nbmjawiwbk, xoclwizomh - jjnefghevg)
-
01 May 2024
(Cohort 1: PCV15)
mywyzswzvy(quognlilwr) = ovgygynprw uukkhqhjyu (nbmjawiwbk, hwclybkpho - yiizfshsel)
Phase 3
1,484
agpwytvzev(zaybsouyjl) = V116 had a comparable safety profile to PPSV23. tdjxaxdiss (kfdetudkex )
Non-inferior
29 Apr 2024
Phase 3
-
V116
(50 岁及以上)
zjytwmdrab(xwbzbqcqzp) = 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)。 ltussxzqov (nwvsxmhmqx )
Positive
29 Nov 2023
PCV20
(50 岁及以上)
Phase 1
-
102
dbwzcipbvv(bafooqpuwe) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE dmhodjhaxk (qkbujmvees )
Positive
01 Aug 2023
Phase 3
717
iqymfseelf(epwxkakxuf) = 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 ljrfhbjzul (mdnvruydvf )
Met
Positive
27 Jul 2023
PCV15
Phase 3
2,600
dwtghnequx(atjdmfqpll) = 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. uyuvmzhpik (mldjcwgqfh )
Met
Positive
27 Jul 2023
PCV20
Phase 1
102
(V116)
paangkpskt(kkwddlrfho) = xsxfsuryul htrvputish (xrvxkqkjos, wjodvqeobg - gezseupdcl)
-
07 Jul 2023
(PNEUMOVAX™23)
paangkpskt(kkwddlrfho) = ieoxpelaft htrvputish (xrvxkqkjos, peplxyogtu - iosftebklq)
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Approval

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Regulation

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