Safety 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 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
Immune 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.
1GMT=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.
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INDICATIONS AND SELECT SAFETY INFORMATION
Prevnar 20® is indicated 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
Prevnar 20® is indicated for 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 of Prevnar 20® 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
Prevnar 13® 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
Do not administer Prevnar 20® or Prevnar 13® to individuals with severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or Prevnar 13® 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® or Prevnar 13® to individuals with severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or Prevnar 13® 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®
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 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
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® is indicated 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
Prevnar 20® is indicated for 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 of Prevnar 20® 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
Prevnar 13® 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
