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

Clinical studies

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Clinical studiesBuilt on an established pneumococcal conjugate vaccine1-4Built on the established efficacy of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])1-3The clinical experience of Prevnar 13 is relevant to Prevnar 20™ because of manufacturing similarities and 13 shared serotypes.1

Prevnar 13 StudyCommunity-Acquired Pneumonia Immunization Trial in Adults (CAPiTA): A landmark efficacy trial3,4

~85,000 participants3,4

Adults age 65 or older, including those with pre-existing, stable medical conditions3,4

Review the safety and efficacy data

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Prevnar 13 StudyReal-world effectiveness2

~2000 participants2

Adults age 65 or older with CAP and pneumococcal vaccination history confirmed by electronic health records2
 

RWE study limitations
  • Observational in nature
  • Low Prevnar 13 uptake in study (~14%)
  • Serotype-specific vaccine effectiveness and stratified analyses not possible
  • May be susceptible to selection bias or confounding factors
  • Overall number of CAP cases was relatively small (n=68)
Prevnar 20 Studies 1, 3, and 6Immunogenicity studies of
Prevnar 201

~6000 participants1

Study 1
Pneumococcal vaccine-naïve adults age 18 or older*
Study 3
3 lot consistency trial in adults age 18 to 49
Study 6
Previously vaccinated adults age 65 or older

Approximately one-third of participants in this study had risk factors that placed them at increased risk for serious pneumococcal disease.1

CAP=community-acquired pneumonia; RWE=real-world effectiveness.
References:
Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2021.McLaughlin JM, Jiang Q, Isturiz RE, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine against hospitalization for community-acquired pneumonia in older US adults: a test-negative design. Clin Infect Dis. 2018;67(10):1498-1506.Bonten MJ, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015;372(12):1114-1125.Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.
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November 2022
Clinical studies With the most serotypes in a pneumococcal conjugate vaccine, you can help protect your eligible adult patients.1 Explore additional protectionLoading Patient profiles to help you determine which of your adult patients are eligible for Prevnar 20. Meet more patient types 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

Please click for Prevnar 20™ Full Prescribing Information.

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