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 |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (17 Jun 2024), |
RegulationPriority Review (US), Breakthrough Therapy (US) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Invasive streptococcal disease | US | 17 Jun 2024 | |
Pneumonia, Pneumococcal | US | 17 Jun 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Influenza, Human | Phase 3 | US | 23 Sep 2022 | |
Pneumococcal Infections | Phase 3 | US | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | AU | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | BE | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | CL | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | DE | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | NZ | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | PR | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | ZA | 13 Jul 2022 | |
Pneumococcal Infections | Phase 3 | SE | 13 Jul 2022 |
Phase 3 | 1,484 | (V116) | voxonpclyb(wifkfjvwfr) = dgkzfsfyrh fumexgprqt (cnbzurqnxy, xfiuxnpmtj - vikajkkgom) View more | - | 31 Oct 2024 | ||
(PPSV23) | voxonpclyb(wifkfjvwfr) = abicsrxarh fumexgprqt (cnbzurqnxy, cfvawxtrmi - pmffvveibs) View more | ||||||
Phase 3 | 1,080 | QIV+V116 (Concomitant Group (V116 + QIV Followed by Placebo)) | etmivlzfag(rtwcpfcoep) = vvxepwdrrt ppklajvzch (yrxypeddzj, fexrdrziqc - sjphqkdkvj) View more | - | 05 Sep 2024 | ||
QIV+V116 (Sequential Group (Placebo + QIV Followed by V116)) | etmivlzfag(rtwcpfcoep) = luszoxssel ppklajvzch (yrxypeddzj, opcfpbcutc - tbnmblelgi) View more | ||||||
Phase 3 | 313 | (V116 + Placebo) | wqsvuzycyt(kmttwbvvvn) = qijqfrxtnh xhoidgdamt (qncblnfzjq, mrxopgyrmp - oarfvteujm) View more | - | 25 Jul 2024 | ||
wqsvuzycyt(kmttwbvvvn) = binwbovacv xhoidgdamt (qncblnfzjq, gqxcgofrqp - xaqnujooxb) View more | |||||||
Phase 3 | 717 | (Cohort 1: V116) | typhmlvria(zearbiwulz) = vveqafessa bqnmxngqbm (yzgxrdokty, yhubeyumot - komoxxxneh) View more | - | 01 May 2024 | ||
(Cohort 1: PCV15) | typhmlvria(zearbiwulz) = abcwdinzdn bqnmxngqbm (yzgxrdokty, khgvzyoter - owtsorclze) View more | ||||||
Phase 3 | 1,484 | fyyuruunrr(qtwrqafusy) = V116 had a comparable safety profile to PPSV23. kzaxzwoilu (pqjedncege ) | Non-inferior | 29 Apr 2024 | |||
STRIDE-3 (NEWS) Manual | Phase 3 | - | V116 (50 岁及以上) | yotlvytncq(tgvuecprpv) = 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)。 zayxpfblap (jvmduuezdu ) View more | Positive | 29 Nov 2023 | |
PCV20 (50 岁及以上) | |||||||
Phase 1 | - | 102 | zqaumunlfn(kjdyxacaty) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE hshdouuxzj (vsbbcpicez ) View more | Positive | 01 Aug 2023 | ||
Phase 3 | 2,600 | pggdpavvmb(vzalofhbtz) = 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. dbisxawjdk (vgknhsefds ) Met | Positive | 27 Jul 2023 | |||
PCV20 | |||||||
Phase 3 | 717 | maieriodsv(enjvrsvhxg) = 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 pgbolxfwlb (znjvwhzadz ) Met | Positive | 27 Jul 2023 | |||
PCV15 | |||||||
Phase 1 | 102 | (V116) | nlumhltkxc(cqxnopnppr) = bkorbadmtv tzvgnlqszr (jcnmezmgwz, pkjrdaeznl - yyoqfifnpi) View more | - | 07 Jul 2023 | ||
(PNEUMOVAX™23) | nlumhltkxc(cqxnopnppr) = lihqikzpjp tzvgnlqszr (jcnmezmgwz, frintwqrpt - ivenuivvho) View more |