Vaccine Info

V114 Pneumococcal Disease Vaccine

Authored by
Staff
Last reviewed
January 12, 2021

V114 Pneumococcal Vaccine Description

V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine in Phase 3 development to prevent pneumococcal disease in adults and children.

V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, commonly associated with invasive pneumococcal disease (IPD) worldwide.

On September 9, 2020, Merck announced the pivotal PNEU-AGE (V114-019) phase 3 study 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. These results are based on opsonophagocytic activity (OPA) responses, measuring vaccine-induced functional antibodies.

The PNEU-AGE study also met the key secondary immunogenicity objective, demonstrating the superiority of V114 compared to PCV13 for serotype 3, a leading cause of invasive pneumococcal disease globally.

In another Phase 3 study, PNEU-TRUE (V114-020), in healthy adults 50 years of age or older, V114 met its primary immunogenicity objective demonstrating equivalent immune response across all 15 serotypes for three different lots of V114. In both studies, V114 was generally well tolerated, with a safety profile comparable to PCV13 and consistent with that observed for V114 in previously reported studies.

These findings, and additional Phase 3 data from Merck’s clinical program, will be presented at a scientific congress in the future and will form the basis of global regulatory licensure applications. 

On November 23, 2020, Merck announced submitting the application to the U.S. FDA and the European Medicines Agency for the V114 vaccine candidate licensure. Dr. Roy Baynes, SVP and head of global clinical development, chief medical officer, Merck Research Laboratories, said in a press release: “These submissions for V114 help bring us closer to offering more options to help protect against pneumococcal disease.”

On January 12, 2021, Dr. Roy Baynes stated in a press release, "Invasive pneumococcal disease in adults is on the rise in many countries, driven by highly-invasive serotypes including serotype 3, which is included in the currently licensed pneumococcal conjugate vaccine, as well as serotypes not included, such as serotypes 22F and 33F."

"Building on our nearly 40 years of experience with PNEUMOVAX® 23, Pneumococcal Vaccine Polyvalent, we have developed V114 as another potentially important option to help protect more adults from invasive pneumococcal disease, especially those who are at increased risk. We look forward to working with the FDA during the review of this application.”

For more information, visit www.merck.com

V114 Pneumococcal Vaccine Indication

The V114 vaccine is indicated to prevent invasive pneumococcal disease (IPD). There are more than 90 different types of pneumococcal bacteria, which can affect adults differently than children.

Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are commonly associated with invasive pneumococcal disease worldwide. Serotypes 22F and 33F currently cause 13 percent of the invasive pneumococcal disease seen among adults aged 65 and older in the U.S. and seven to 12% of the adult cases seen across Europe.

Additionally, serotype 3 remains one of the top causes of invasive pneumococcal disease in adults and children despite being included in the currently available pneumococcal vaccines. In the U.S., 15 percent of invasive pneumococcal disease among adults aged 65 and older continues to be caused by serotype 3; this ranges from 12 to 18% of cases in adults across European countries.

V114 Pneumococcal Vaccine Dosage

V114 is administered as an intramuscular injection.

V114 Pneumococcal Vaccine Updates

January 12, 2021 - Merck announced the U.S. 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. The FDA set a Prescription Drug User Fee Act, or target action date, of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.

November 23, 2020 - Merck announced the company had submitted applications to the U.S. 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. The company awaits acceptance of the U.S. and European regulatory authorities' submissions. The regulatory applications for licensure of V114 include results from Phase 2 and Phase 3 clinical studies in a variety of adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older.

October 20, 2020 - Merck announced Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine.  In the PNEU-PATH (V114-016) study, healthy adults 50 years of age or older received V114 or PCV13 followed by PNEUMOVAX® 23 one year later. Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in vaccination groups for the 15 serotypes in V114. Results also showed that at 30 days post-vaccination with either V114 or PCV13 (day 30), immune responses were comparable for both groups across the 13 serotypes shared by the conjugate vaccines and higher in the V114 group for serotypes 22F and 33F, the two serotypes not included in PCV13.

September 12, 2020 - The V114 pneumococcal vaccine candidate, which includes 15 serotypes, is non-inferior to the 13-valent vaccine currently on the market for adults.

September 9, 2020 - Merck announced that two Phase 3 studies evaluating the safety, tolerability, and immunogenicity of V114, the investigational 15-valent pneumococcal conjugate vaccine, met their primary immunogenicity objectives. These findings and additional Phase 3 data from Merck’s clinical program will be presented at a scientific congress in the future. They will form the basis of global regulatory licensure applications, beginning with the U.S. FDA before the end of 2020. Dr. Roy Baynes, SVP and head of global clinical development, chief medical officer, Merck Research Laboratories. “Continued scientific innovation in pneumococcal disease prevention is needed to target the serotypes that pose the greatest risk to specific populations while maintaining immune response as new serotypes are added. These Phase 3 data demonstrated that V114 generated a robust immune response to all 15 serotypes included in the vaccine and reinforced the potential for this investigational vaccine to help protect adults against pneumococcal disease.”

January 30, 2019 - Merch announced that V114 received a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) to prevent invasive IPD caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age.

June 22, 2020 - Merck announced results from two initial Phase 3 studies evaluating the safety, tolerability, and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. The PNEU-WAY (V114-018) study in adults 18 years of age or older living with Human Immunodeficiency Virus (HIV) showed that V114 elicited immune response all 15 serotypes included in the vaccine, including serotypes 22F and 33F. The PNEU-FLU (V114-021) study in healthy adults 50 years of age or older showed that V114 could be given concomitantly with the quadrivalent influenza vaccine. 

May 8, 2019 - Merch announced V114 Met Primary Endpoint by Demonstrating Noninferiority to PCV13 for all Shared Serotypes, and an Immune Response for Two Additional Serotypes.

V114 Pneumococcal Vaccine Clinical Trials

Pediatric Clinical Trials: 

NCT02987972  A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

NCT03692871  A Phase 3 Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

NCT03620162  A Phase 3 Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

NCT03885934  A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (V114-024) (PNEU-PLAN)

NCT03893448  A Phase 3 Study to Evaluate Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (PNEU-PED)

Adult Clinical Trials:

NCT03480763  A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)

NCT03615482  A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU)

NCT03950622 A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (V114-019 /PNEU-AGE)

NCT03950856 A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (V114-020 PNEU-TRUE)

Immunocompromised persons and those at increased risk for invasive pneumococcal disease Clinical Trials:     

NCT03547167  A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)     

NCT03921424  A Phase 3 Study to Evaluate the Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED) (PNEU-WAY PED)                 

NCT03731182  A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)

NCT03480802  A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018/PNEU-WAY)

NCT03565900  A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)