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HomePrevnar 20®Prevnar 20®Serotypes matterAdministrationBurden of diseaseBurden
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Prescribing InformationIndicationPatient SiteOrder Prevnar 20®
Study 1Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) immunogenicity in pneumococcal vaccine-naïve adults1
Study 1: Study design
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Prevnar 20 was studied in pneumococcal vaccine-naïve patients1
Study descriptionPhase 3 randomized, active-controlled, double-blind, noninferiority clinical trial
CountriesUnited States and Sweden
Age (years)≥18
EvaluatedSafety and noninferior immunogenicity of Prevnar 20 (n=1157-1430) in pneumococcal vaccine-naïve adults as compared to:
  • PCV13 (n=1390-1419) for the 13 shared serotypes in adults age 60 or older
  • PPSV23 (n=1201-1319) for 7 additional serotypes not in PCV13 in adults age 60 or older
  • Noninferior immunogenicity of Prevnar 20 in adults age 18-49 and 50-59 as compared to adults age 60-64 (immunobridging)
Risk factorsHealthy 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 measuresImmune responses elicited by Prevnar 20 and the control pneumococcal vaccines were measured by OPA assay. Serotype-specific OPA GMTs were measured before vaccination and 1 month after vaccination.

Noninferiority of immune responses was evaluated for adults age 60 
or older.

Immunobridging in adults age 18-59: The effectiveness of Prevnar 20 in adults age 50-59 and in adults age 18-49 was inferred following comparison of the immune response to each of the 20 vaccine serotypes in each of these age groups to the corresponding serotype-specific immune responses in adults age 60-64 following Prevnar 20.
Study 3 evaluated the safety and immunogenicity of 3 lots of Prevnar 20 in pneumococcal vaccine-naïve adults age 18 to 49. 1 GMT=geometric mean titer; IPD=invasive pneumococcal disease; OPA=opsonophagocytic activity; PCV13=Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]); PPSV23=23-valent pneumococcal polysaccharide vaccine. Reference: Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2023. Clinical studies Study 1: Prevnar 20 demonstrated immunogenicity across adult populations. 1 Review the data Loading With 20 serotypes in its pneumococcal conjugate vaccine, you can help protect your eligible adult patients. 1 Explore additional protection Loading
This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.Manufactured by Wyeth Pharmaceuticals LLC.
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INDICATION AND SELECT SAFETY INFORMATION
  • Prevnar 20® is a vaccine approved for:​​​​​
    • active immunization for the prevention of 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 individuals 6 weeks of age and older
    • active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older
  • The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older 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
SELECT SAFETY INFORMATION
  • Do not administer Prevnar 20® to individuals with severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or to diphtheria toxoid
  • 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
  • Do not administer Prevnar 20® to individuals with severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or to diphtheria toxoid
  • 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®
  • In individuals 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 individuals 18 through 59 years of age
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.INDICATION
  • Prevnar 20® is a vaccine approved for:
    • active immunization for the prevention of 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 individuals 6 weeks of age and older
    • active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older
  • The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older 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