Drugs / V116
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | idiopathic severe pneumococcemia | 2023-12-19 | “today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for V116” merck.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04665050 | Feb → Apr 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT04168190 | Dec 2019 → Jul 2021 | streptococcal pneumonia | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 39 trials · 2 met primary | ||||||
| Phase 3 | NCT06177912 | Jan 2024 → Feb 2025 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT05696080 | Feb 2023 → Feb 2024 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT05633992 | Jan → May 2023 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT05569954 | Nov 2022 → Oct 2023 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT05526716 | Sep 2022 → Jun 2023 | streptococcal pneumonia | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT05464420 | Aug 2022 → May 2023 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT05425732 | Jul 2022 → May 2023 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT05393037 | Jul 2022 → Jul 2023 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT05420961 | Jul 2022 → May 2023 | streptococcal pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2024-10-16 | Merck Sharp & Dohme LLC | Results Merck’s CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) Demonstrates Positive Immune Responses in Adults with Increased Risk for Pneumococcal Disease merck.com ↗
The proportions of participants with adverse events (AEs), including injection-site, systemic, and vaccine-related AEs, were numerically lower in the V116 + placebo group than in the PCV15 + PPSV23 group. |
| 2024-06-27 | Merck Sharp & Dohme LLC | Regulatory CDC’S ACIP Unanimously Recommends Merck’s CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Appropriate Adults merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) as an option for adults 65 years of age and older for pneumococcal vaccination. |
| 2024-06-24 | MSD R&D (China) Co., Ltd. | Regulatory CAPVAXIVE™（21価肺炎球菌結合型ワクチン）、成人の侵襲性肺炎球菌感染症および肺炎球菌性肺炎の予防ワクチンとして 米国FDAの承認を取得 msd.co.jp ↗
2024年6月17日：ニュージャージー州ローウェイ Merck & Co., Inc., Rahway, NJ, USA（米国とカナダ以外ではMSD）は本日、CAPVAXIVE™（21価肺炎球菌結合型ワクチン）が、以下を予防する能動免疫のワクチンとして米国食品医薬品局（FDA）の承認を取得したことを発表しました。 |
| 2024-06-18 | Ligand Pharmaceuticals | Regulatory Ligand Collaborator Merck Receives FDA Approval for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Adults ligand.com ↗
“We are excited to see our longstanding collaborator Merck receive regulatory approval for CAPVAXIVE,” said Todd Davis, CEO of Ligand. |
| 2024-06-17 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Approves CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for: |
| 2024-05-29 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USA 成人向けに特化して設計された、開発中の 21価肺炎球菌結合型ワクチンV116の良好なデータを発表 msd.co.jp ↗
V116は、PPSV23と共通する12種類の血清型において、PPSV23に対して免疫応答の非劣性を示しました。 |
| 2024-04-29 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults merck.com ↗
V116 elicited immune responses that were noninferior compared to PPSV23 for the 12 serotypes (or strains) common to both vaccines, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30. |
| 2024-03-22 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, N.J., U.S.A. 成人向けに特化して設計された、開発中の 21価肺炎球菌結合型ワクチンV116の良好なデータを発表 成人における免疫応答を示す msd.co.jp ↗
またV116固有の血清型については、本学会で発表されたすべてのSTRIDE試験（一連のV116試験プログラム）で、比較対照とされたワクチンより高い免疫応答が誘導されました。 |
| 2024-03-19 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults merck.com ↗
V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting. |
| 2023-12-19 | Merck Sharp & Dohme LLC | Regulatory FDA Grants Priority Review to Merck’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. |
| 2023-11-30 | MSD R&D (China) Co., Ltd. | Results 成人向けに特化して設計された、開発中の21価肺炎球菌結合型ワクチンV116、50歳以上の成人において、V116固有の11種類の血清型のうち10種類の血清型に対し、PCV20と比較し免疫原性の優越性を示す msd.co.jp ↗
V116に含まれPCV20に含まれない11種類の血清型のうち10種類について、V116は免疫応答の優越性が示されました。 |
| 2023-11-28 | Merck Sharp & Dohme LLC | Results Merck’s V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults, Demonstrated Superior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20 in Adults 50 Years of Age and Older merck.com ↗
In adults 50 years of age and older (Cohort 1), V116 elicited non-inferior immune responses compared to PCV20 for all 10 serotypes common to both vaccines as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30. |
| 2023-08-31 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, N.J., U.S.A. 成人向けに特化して開発中の21価肺炎球菌結合型ワクチンV116が2つの第3相試験で免疫原性と安全性の主要評価項目を達成したことを発表 トップラインの結果から、V116はワクチン未接種および接種歴のある成人の両者において 良好な免疫原性を誘導することが示される V116が対応する21種類の血清型は65歳以上の成人の侵襲性肺炎球菌感染症の85%を占める msd.co.jp ↗
Merck & Co., Inc., Rahway, N.J., U.S.A.（米国とカナダ以外ではMSD）は本日、肺炎球菌ワクチン未接種の成人および接種歴のある成人を対象として開発中の21価肺炎球菌結合型ワクチンV116を評価した2つの第3相試験の良好なトップラインデータを発表しました。 |
| 2023-07-27 | Merck Sharp & Dohme LLC | Results Merck Announces V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Met Key Immunogenicity and Safety Endpoints in Two Phase 3 Trials merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from two Phase 3 trials evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine in vaccine-naïve and previously vaccinated individuals. |
| 2023-07-27 | Ligand Pharmaceuticals | Results Ligand’s Collaborator Merck Announces V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Met Key Immunogenicity and Safety Endpoints in Two Phase 3 Trials ligand.com ↗
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its collaborator Merck, known as MSD outside of the United States and Canada, today announced positive topline results from two Phase 3 trials evaluating V116, an investigational 21-valent pneumococcal conjugate vaccine in vaccine-naïve and previously vaccinated individuals. |
| 2022-07-28 | Merck Sharp & Dohme LLC | Results Merck Announces Second-Quarter 2022 Financial Results merck.com ↗ |
| 2022-06-29 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, N.J., USA 開発中の成人向け肺炎球菌結合型ワクチンV116の第1/2相試験の良好な結果を公表 V116は、米国で65歳以上の成人侵襲性肺炎球菌感染症の 85%（2019年時点）を占める血清型を標的としてデザイン¹ 未接種および接種済みの成人を対象とするV116の大規模な第3相臨床プログラムを 2022年7月に開始予定 msd.co.jp ↗
いずれの集団においても、V116は免疫原性の主要目的を達成し、忍容性は良好で、全般的な安全性プロファイルは全年齢層でPNEUMOVAX®23（多価肺炎球菌ワクチン）と概ね同様でした。 |
| 2022-06-21 | Merck Sharp & Dohme LLC | Results Merck Presents Positive Results from Phase 1/2 Study Evaluating V116, the Company’s Investigational Pneumococcal Conjugate Vaccine for Adults merck.com ↗
In both populations, V116 met the primary immunogenicity objectives and was well-tolerated with an overall safety profile generally comparable to PNEUMOVAX ® 23 (Pneumococcal Vaccine Polyvalent) across age groups. |
| 2022-04-28 | Merck Sharp & Dohme LLC | Regulatory Merck Announces First-Quarter 2022 Financial Results merck.com ↗
Merck announced receipt of breakthrough therapy designation from the FDA for V116, the company’s investigational 21-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults caused by the serotypes in the vaccine. |
| 2022-04-14 | Merck Sharp & Dohme LLC | Regulatory Merck Announces U.S. FDA has Granted Breakthrough Therapy Designation for V116, the Company’s Investigational 21-Valent Pneumococcal Conjugate Vaccine, for the Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that V116, the company’s investigational 21-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and older. |
All press releases naming this drug 20 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | V116 | “Background: V116 is a 21-valent pneumococcal conjugate vaccine (PCV) designed for adults.” PMID 40333240 ↗ Mar 2025 |
| Modality | Vaccine | “Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen” NCT04665050 ↗ |
| Route | Intramuscular | “a single intramuscular (IM) dose of V116 on Day 1” NCT05393037 ↗ |