Vaccine Info

PF-06482077 20-Valent Pneumococcal Vaccine

Description

PF-06482077 is a 20-Valent pneumococcal conjugate vaccine candidate to help protect adults from a substantial invasive pneumococcal disease and pneumonia burden

Indication

PF-06482077 is a 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults aged 18 years and older.

Dosage

PF-06482077 is administered as an intramuscular injection

Updates

March 18, 2020: Pfizer Inc. announced top-line results from a Phase 3 clinical trial which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate.

Pfizer’s press release stated: The primary immunogenicity objectives of non-inferiority for the 20 serotypes included in 20vPnC in adults 60 years of age and older at 1-month after vaccination, were met for all serotypes in common with licensed Prevnar 13, and six of the seven additional serotypes when compared to a licensed pneumococcal polysaccharide vaccine (PPSV23).

September 9, 2019: Pfizer Inc. announced positive preliminary results following administration of three doses in a four-dose series for a Proof-of-Concept Phase 2 study (B7471003) to assess safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes contained in the vaccine in healthy infants.

Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).

September 20, 2018: “As the industry leader in pneumococcal conjugate vaccination, we are proud to start the Phase 3 trials of our third generation pneumococcal vaccine, which received Breakthrough Therapy Designation by the FDA in September 2018.”

Clinical Trials

Clinical Trials NCT03512288: Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

  • A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

Clinical Trial NCT03835975: Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination (Recruiting)

  • This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination

Clinical Trial NCT03760146: Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults (Active)

  • A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

Clinical Trial NCT03828617: Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults (Active)

  • This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.

 

Updated
03/19/2020 - 07:49