Vaccine Info

V114 Pneumococcal Disease Vaccine

Description

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.

Indication

V114 is indicated to prevent invasive pneumococcal disease (IPD).

Dosage

V114 is administered as an intramuscular (IM) injection

Updates

V114 also induced an immune response in infants for two additional disease-causing serotypes, 22F and 33F, which are not contained in PCV13.

In January 2019, 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

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)

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
September 4th, 2019