Drugs / V114
V114
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vaxneuvance | — | 2021-12-13 | europa.eu ↗ |
Trials 29 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05489328 | Aug → Oct 2022 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03848065 | Apr 2019 → Jun 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01215175 | Sep 2009 → Apr 2010 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02531373 | Sep 2015 → Apr 2017 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT02037984 | Jan 2014 → Jul 2016 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT02987972 | Mar 2017 → Oct 2018 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT02573181 | Oct 2015 → Jan 2016 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT01513551 | Mar 2012 → Feb 2013 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT01215188 | Oct 2010 → Jul 2012 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 319 trials | ||||||
| Phase 3 | NCT05158140 | Jan 2022 → Feb 2023 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT04633226 | Feb 2021 → Nov 2022 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT04193215 | Sep 2020 → Dec 2025 | otitis media | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT04384107 | Jul 2020 → Dec 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03921424 | Nov 2019 → May 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT04031846 | Sep 2019 → Aug 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT04016714 | Aug 2019 → Oct 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03885934 | Jun 2019 → Dec 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03893448 | Jun 2019 → May 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03950622 | Jun 2019 → Mar 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03950856 | Jun 2019 → Apr 2020 | streptococcal pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03731182 | Jan 2019 → Jun 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03692871 | Dec 2018 → Mar 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03620162 | Oct 2018 → Dec 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03615482 | Sep 2018 → Jun 2019 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03565900 | Sep 2018 → Nov 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03547167 | Jul 2018 → Jan 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03480802 | Jul 2018 → Sep 2019 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03480763 | Jun 2018 → Dec 2019 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06731374 | Feb → Dec 2025 overdue | pneumococcal infection | University of Oxford | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 38 trials | ||||||
| Phase 3 | NCT06975878 Comparator | May 2025 → Aug 2027 expected | — | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06806137 Background | May 2025 → Dec 2026 expected | chickenpox | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06855160 Background | Apr 2025 → Sep 2026 expected | chickenpox | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06740630 Background | Jan 2025 → Dec 2026 expected | chickenpox | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06693895 Background | Nov 2024 → Nov 2026 expected | chickenpox | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT05696080 Comparator | Feb 2023 → Feb 2024 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT05393037 Comparator | Jul 2022 → Jul 2023 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT05420961 Comparator | Jul 2022 → May 2023 | streptococcal pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | V114 | “V114 is a 15-valent PCV that contains two epidemiologically important serotypes, 22F and 33F, in addition to the 13 serotypes present in PCV13, the licensed 13-valent PCV.” PMID 36150974 ↗ Sep 202226 |
| Known as | PCV-15 | “One dose (0.5 ml) of PCV-15 is to be given Intramuscularly (IM) into the deltoid region of the arm at day 0.” NCT06731374 ↗ |
| Known as | Vaxneuvance | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06855160 ↗ |
| Known as | VAXNEUVANCETM | “V114 (VAXNEUVANCETM, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA) is a 15-valent PCV” PMID 34507861 ↗ Sep 2021 |
| Modality | Vaccine | “15-valent pneumococcal conjugate vaccine (V114)” NCT01215175 ↗ |
| Route | Intramuscular | “single 0.5 mL intramuscular injection of aluminum adjuvanted V114” NCT01215175 ↗ |