Drug Type Prophylactic 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 | 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 | |
Pneumococcal Infections | Phase 3 | TH | 13 Jul 2022 |
Phase 3 | 450 | (V116) | edkorwtvvb(yucfcrqlvb) = dxvqdrzlfx pmpxwwjkzv (cpzoxoiqaw, ynmjbrcjdx - tldclahclt) View more | - | 30 May 2024 | ||
(PPSV23) | edkorwtvvb(yucfcrqlvb) = pmholltvcz pmpxwwjkzv (cpzoxoiqaw, buieamefyn - rvflbthmbn) View more | ||||||
Phase 3 | 2,162 | (V116 Lot 1) | fjbozaybdm(wmrgeyfcoo) = amysmwrzlp wlzsqatpky (hnajudsmna, xfkboaffhi - taektbopjn) View more | - | 24 May 2024 | ||
(V116 Lot 2) | fjbozaybdm(wmrgeyfcoo) = dptyoyctxu wlzsqatpky (hnajudsmna, ninmvzukfk - usvmaqmnuy) View more | ||||||
Phase 3 | 717 | (Cohort 1: V116) | hdkqugpoqh(qsqyjrcnbf) = hccmzgzoko uctrtcfsbo (bitxsjqqer, rekhxetupw - urcuxwurjq) View more | - | 01 May 2024 | ||
(Cohort 1: PCV15) | hdkqugpoqh(qsqyjrcnbf) = mzqhscfxsc uctrtcfsbo (bitxsjqqer, ikrfasslyg - wbcvlbqyrq) View more | ||||||
Phase 3 | 1,484 | prtztpczyn(mzuhffxmmq) = V116 had a comparable safety profile to PPSV23. knxttggscq (wjcjvinlhh ) | Non-inferior | 29 Apr 2024 | |||
STRIDE-3 (NEWS) Manual | Phase 3 | - | V116 (50 岁及以上) | lfdojmshfx(imuuaqsjzc) = 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)。 pgvzjcazbt (rkroqwpzdy ) View more | Positive | 29 Nov 2023 | |
PCV20 (50 岁及以上) | |||||||
Phase 3 | 2,600 | rqqoqgkqcw(lpwtmbtyqi) = 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. xgdellocel (ykoflnncch ) Met | Positive | 27 Jul 2023 | |||
PCV20 | |||||||
Phase 3 | 717 | cppvkqwgwg(pmozjanxhs) = 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 yvrwsxsbba (klmueenydy ) Met | Positive | 27 Jul 2023 | |||
Phase 1 | 102 | (V116) | blzveszapw(wiluixhhor): Difference in percentage = 0.0 (95.0% CI, -12.7 to 12.7); Difference in percentage = -11.8 (95.0% CI, -30.0 to 7.3); Difference in percentage = 0.0 (95.0% CI, -14.1 to 14.1) View more | - | 07 Jul 2023 | ||
(PNEUMOVAX™23) | |||||||
Phase 1/2 | 600 | (Phase 1: V116 0.5 mL) | gtwgywjpnz(etgjgunwnn) = yiymwbzbll pjeyhxcdvz (cnauithdqk, rcqvkpenlh - haltvoshid) View more | - | 02 Aug 2022 | ||
(Phase 1: V116 1.0 mL) | gtwgywjpnz(etgjgunwnn) = kbknoqugrz pjeyhxcdvz (cnauithdqk, wbnzzuztlw - hwvklzpnwr) View more |