Vaccine Info

V114 Pneumococcal Disease Vaccine

V114 Pneumococcal Vaccine Description

V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine in Phase 3 development for the prevention of 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, which are 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 – a measure of 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, beginning with the U.S. FDA, before the end of 2020.

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

October 20, 2020 - Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

September 12, 2020 - 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 and will form the basis of global regulatory licensure applications, beginning with the U.S. Food and Drug Administration, before the end of the year.

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

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)
Updated
10/20/2020 - 13:09