Drugs / V114
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| 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 · 1 met primary | ||||||
| Phase 2 | NCT02987972 | Mar 2017 → Oct 2018 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 · 5 met primary | ||||||
| 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 | Mixed |
| 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 | Met primary |
| Phase 3 | NCT04016714 | Aug 2019 → Oct 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 | Mixed |
| Phase 3 | NCT03950622 | Jun 2019 → Mar 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 | Met primary |
| 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 | Met primary |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2024-11-07 | MSD R&D (China) Co., Ltd. | Results CAPVAXIVE™（21価肺炎球菌結合型ワクチン）、肺炎球菌感染症の罹患リスクの高い成人において良好な免疫応答を示す msd.co.jp ↗
CAPVAXIVE™の免疫応答を接種後30日目における血清型特異的OPA GMTおよびIgG GMCで評価したところ、PCV15接種後のPPSV23の追加接種と比較して、共通の13種類の血清型については同等で、CAPVAXIVE™に固有の8種類の血清型については高くなりました。 |
| 2022-10-24 | Merck Sharp & Dohme LLC | Regulatory European Commission Expands Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Indication to Include Infants, Children and Adolescents merck.com ↗
The approval facilitates availability of VAXNEUVANCE for this population in all 27 European Union (EU) Member States plus Iceland, Norway and Lichtenstein. |
| 2022-09-16 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive CHMP Opinion for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Infants and Children merck.com ↗
The CHMP opinion will now be considered by the European Commission (EC) for amending the marketing authorization in the EU, and a final decision is expected by the end of the year. |
| 2022-07-28 | Merck Sharp & Dohme LLC | Regulatory Merck Announces Second-Quarter 2022 Financial Results merck.com ↗
The U.S. Food and Drug Administration (FDA) Approved Merck’s VAXNEUVANCE for the Prevention of Invasive Pneumococcal Disease in Infants and Children |
| 2022-07-04 | MSD R&D (China) Co., Ltd. | Regulatory Merck & Co., Inc., Rahway, N.J., USA 乳児および小児に対する侵襲性肺炎球菌感染症を予防するワクチンとして VAXNEUVANCE™（15価肺炎球菌結合型ワクチン）の承認を米国FDAから取得 承認の裏付けとなった臨床データで、4回接種シリーズを完了後、PCV13と共通の全血清型についてPCV13と比較して免疫応答の非劣性が示され、疾患の重要な原因である共通の血清型3とPCV13に含まれない血清型22Fおよび33Fについて優越性が示された この追加適応により、VAXNEUVANCE™は小児の侵襲性肺炎球菌感染症を予防する、 ほぼ10年ぶりの新たな肺炎球菌結合型ワクチンに msd.co.jp ↗
Merck & Co., Inc., Rahway, N.J., USA（米国とカナダ以外ではMSD）は本日、VAXNEUVANCE™（15価肺炎球菌結合型ワクチン）の生後6週から17歳までの小児への適応拡大の承認を米国食品医薬品局（FDA）から取得したことを発表しました。 |
| 2022-06-22 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Approves Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) to include children 6 weeks through 17 years of age. |
| 2022-06-22 | Merck Sharp & Dohme LLC | Regulatory CDC’s ACIP Unanimously Votes to Provisionally Recommend Use of Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) as an Option for Pneumococcal Vaccination in Infants and Children merck.com ↗
Additionally, the ACIP unanimously voted to include VAXNEUVANCE in the Vaccines for Children program. |
| 2022-04-28 | Merck Sharp & Dohme LLC | Regulatory Merck Announces First-Quarter 2022 Financial Results merck.com ↗
Merck announced the FDA has extended the Prescription Drug User Fee Act date for the supplemental biologics license application for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) in infants and children to July 1, 2022. |
| 2022-04-01 | Merck Sharp & Dohme LLC | Regulatory Merck Provides Update on FDA Review of Supplemental Biologics License Application for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental biologics license application (sBLA) for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in infants and children to July 1, 2022. |
| 2021-12-15 | Merck Sharp & Dohme LLC | Regulatory European Commission Approves Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Individuals 18 Years of Age and Older merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today the European Commission (EC) has approved VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. |
| 2021-12-01 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age. |
| 2021-10-28 | Merck Sharp & Dohme LLC | Results Merck Announces Third-Quarter 2021 Financial Results merck.com ↗
Merck announced positive topline results from the pivotal Phase 3 PNEU-PED (V114-029) study evaluating the immunogenicity, safety and tolerability of VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) in healthy infants enrolled between 42-90 days of age. |
| 2021-10-20 | Pfizer | Regulatory Advisory Committee on Immunization Practices Votes to Recommend Routine Use of Pfizer’s PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in Adults pfizer.com ↗
Adults 65 years of age or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15). |
| 2021-10-20 | Merck Sharp & Dohme LLC | Regulatory CDC ACIP Unanimously Votes to Provisionally Recommend Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Series with PNEUMOVAX ® 23 (Pneumococcal Vaccine Polyvalent) as an Option for Pneumococcal Vaccination in Appropriate Adults merck.com ↗
In both groups, the ACIP voted to provisionally recommend vaccination either with a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX 23, or with a single dose of 20-valent pneumococcal conjugate vaccine. |
| 2021-10-15 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive CHMP Opinion for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Individuals 18 Years of Age and Older merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. |
| 2021-08-25 | Merck Sharp & Dohme LLC | Results Merck Announces VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Met Key Immunogenicity and Safety Endpoints in Phase 3 Pivotal Trial Evaluating Use in Infants, PNEU-PED (V114-029) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced topline results from the pivotal PNEU-PED (V114-029) study evaluating the immunogenicity, safety and tolerability of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in healthy infants enrolled between 42-90 days of age (n=1720). |
| 2021-07-19 | Ligand Pharmaceuticals | Regulatory Ligand’s Partner Merck Receives FDA Approval for VAXNEUVANCE™ for the Prevention of Invasive Pneumococcal Disease in Adults Caused by 15 Serotypes ligand.com ↗
Ligand’s Partner Merck Receives FDA Approval for VAXNEUVANCE™ for the Prevention of Invasive Pneumococcal Disease in Adults Caused by 15 Serotypes |
| 2021-07-16 | Merck Sharp & Dohme LLC | Regulatory Merck Announces U.S. FDA Approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes merck.com ↗ |
| 2021-05-20 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Topline Results from PNEU-DIRECTION (V114-027) and PNEU-PLAN (V114-024) Phase 3 Pediatric Studies for V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, met its primary immunogenicity and safety endpoints in two trials of the V114 Phase 3 pediatric clinical program. |
| 2021-01-13 | Ligand Pharmaceuticals | Regulatory Ligand Receives Milestone Payment from Merck ligand.com ↗
Milestone payment triggered by acceptance for review of a BLA for V114, an investigational 15-valent pneumococcal conjugate vaccine that utilizes Ligand’s CRM197 carrier protein |
| 2021-01-12 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, for Use in Adults 18 Years of Age and Older merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older. |
| 2020-11-23 | Merck Sharp & Dohme LLC | Regulatory Merck Submits Applications for Licensure of V114, the Company’s Investigational 15-valent Pneumococcal Conjugate Vaccine, for Use in Adults to the U.S. FDA and European Medicines Agency merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the company has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for licensure of V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older. |
| 2020-10-20 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine merck.com ↗ |
| 2020-09-09 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Topline Results from Two Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, Including Pivotal Trial merck.com ↗
The pivotal PNEU-AGE (V114-019) study in healthy adults 50 years of age or older demonstrated that V114 is non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 serotypes targeted by both vaccines and superior for serotypes 22F and 33F, the two serotypes targeted by V114 but not PCV13. |
| 2020-07-31 | Merck Sharp & Dohme LLC | Results Merck Announces Second-Quarter 2020 Financial Results merck.com ↗
Merck announced results from two initial Phase 3 studies that showed V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, met safety and immunogenicity objectives in the PNEU-WAY (V114-018) and PNEU-FLU (V114-021) studies in adults; and |
| 2020-06-22 | Merck Sharp & Dohme LLC | Results Merck Announces That V114, Its Investigational 15-valent Pneumococcal Conjugate Vaccine, Met Safety and Immunogenicity Objectives in Initial Phase 3 Studies in Adults merck.com ↗
Results from the PNEU-WAY (V114-018) study in adults 18 years of age or older living with Human Immunodeficiency Virus (HIV) showed that V114 elicited an immune response to all 15 serotypes included in the vaccine, including serotypes 22F and 33F. |
| 2019-05-08 | Merck Sharp & Dohme LLC | Results Merck Announces Results from Phase 2 Trial of Investigational 15-valent Pneumococcal Conjugate Vaccine (V114) in Infants merck.com ↗
In the study, designated V114-008, V114 met its primary endpoint by demonstrating noninferiority for the 13 serotypes contained in both vaccines. |
| 2019-01-30 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Breakthrough Therapy Designation from FDA for V114, the Company’s Investigational 15-Valent Conjugate Vaccine for the Prevention of Invasive Pneumococcal Disease, in Infants, Children, and Adolescents merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that V114, the company’s investigational 15-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) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. |
All press releases naming this drug 29 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 28 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 2022 |
| 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 ↗ |