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HomePrevnar 20®Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine)Broad pneumococcal defenseMOABurden of diseaseIPDCAPACIP recommendationsACIP recommendationsACIP recommendationsPatient profilesClinical studies

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Study 6Study 6Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) immunogenicity in previously vaccinated adults1Study 6: Study design
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Prevnar 20 was studied in previously vaccinated patients1,2
Study description Phase 3 randomized, open-label clinical trial
Countries United States and Sweden
Age (years) ≥65
Evaluated Safety and immunogenicity of Prevnar 20 in patients previously vaccinated with:
 
  • PPSV23 (≥1 to ≤5 years prior to enrollment, n=253) 
  • PCV13 (≥6 months prior to enrollment, n=245)
  • PCV13 followed by PPSV23 (with PPSV23 ≥1 year prior to enrollment, n=125)
Risk factors Healthy and immunocompetent adults with stable underlying conditions, including chronic cardiovascular disease, chronic pulmonary disease, renal disorders, diabetes, chronic liver disease, and medical risk conditions and behaviors (eg, smoking) that are known to increase the risk of serious pneumococcal pneumonia and IPD.
Response measures There is no noninferiority analysis of Study 6.
IPD=invasive pneumococcal disease; PCV13=Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]); PPSV23=23-valent pneumococcal polysaccharide vaccine.References:Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2022.Data on file. Pfizer Inc.
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Manufactured by Wyeth Pharmaceuticals LLC.
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January 2023
Clinical studiesStudy 6: Prevnar 20 was evaluated in adults age 65 or older who were previously vaccinated.1 Review the data LoadingWith the most serotypes in a pneumococcal conjugate vaccine, you can help protect your eligible adult patients.1 Explore additional protection Loading

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INDICATIONS AND SELECT SAFETY INFORMATION
  • Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older
  • The indication of Prevnar 20® for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
  • Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults 18 years of age and older
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine

SELECT SAFETY INFORMATION
 
  • Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20®, Prevnar 13®, or to diphtheria toxoid is a contraindication
  • Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20® 
Important Safety Information
  • Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20®, Prevnar 13®, or to diphtheria toxoid is a contraindication
  • Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20®
  • Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response to Prevnar 13®
  • For Prevnar 20®, in adults 18 years of age and older, the most commonly reported solicited adverse reactions (>10%) were pain at the injection site, muscle pain, fatigue, headache, and arthralgia. Additionally, injection site swelling was also reported (>10%) in adults 18 through 59 years of age  
  • For Prevnar 13®, in adults 18 years of age and older, the most commonly reported solicited adverse reactions (>5%) were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

Please click for Prevnar 20® Full Prescribing Information.

Please click for Prevnar 13® Full Prescribing Information.Indications
  • Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older
  • The indication of Prevnar 20® for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
  • Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diptheria CRM197 Protein]) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults 18 years of age and older
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine