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Home20 Serotypes20 SerotypesSerotype coverageCase CoverageDisease BurdenEfficacyEfficacyInvasive Pneumococcal DiseaseOtitis MediaClinical Trial Results

Clinical Trial
Results

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Prescribing InformationPatient InformationIndications Patient Site
ImmunogenicityPrevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) demonstrated a robust immune response against 20 serotypes after 4 doses1Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) demonstrated a robust immune response against 20 serotypes after 4 doses1 Prevnar 20® produced high levels of antibodies against 20 serotypes that cause invasive pneumococcal disease (IPD)1

Primary endpoint: Mean IgG concentration after Dose 42

Noninferiority for a particular serotype was declared if the lower bound of the 2-sided 95% CI for the GMC ratio (Prevnar 20®/Prevnar 13®) for that serotype was >0.5. The 7 additional serotypes were compared to the GMC ratio of the lowest response from Prevnar 13® (serotype 1), excluding serotype 3.1CI=confidence interval; GMC=geometric mean concentration; IgG=immunoglobulin G.Percentage reaching prespecified IgG concentrations post Dose 3Percentage reaching prespecified IgG concentrations post Dose 3 Prevnar 20® patients reaching prespecified IgG concentrations 1 month after Dose 31

Primary endpoint: Prespecified IgG concentration post Dose 3

Noninferiority for a particular serotype was declared if the lower bound of the 2-sided 95% CI for the percentage difference (Prevnar 20® minus Prevnar 13®) was >-10%. Predefined levels were ≥0.35 μg/mL for all serotypes except for serotypes 5, 6B, 12F, and 19A, which were ≥0.23 μg/mL, ≥0.10 μg/mL, ≥0.69 μg/mL, and ≥0.12 μg/mL, respectively. The 7 additional serotypes are plotted with the results for serotype 23F (lowest in Prevnar 13® group, excluding serotype 3).1 Prevnar 20® demonstrated functional OPA antibody responses against all 20 serotypes1Prevnar 20® demonstrated functional OPA antibody responses against all 20 serotypes1

Selected Secondary Endpoint Post Dose 3 and Post Dose 4: OPA GMTs*

 Prevnar 20® demonstrated functional OPA antibody responses against all 20 serotypes1

Post Dose 3 and Post Dose 4: OPA GMTs*

OPA titers were determined from randomly selected subsets of participants ensuring equal representation of both vaccine groups.1GMT=geometric mean titer; OPA=opsonophagocytic activity.
See safety data for Prevnar 20® compared to Prevnar 13®
LoadingReferences:Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2023. National Institute of Health. 20-Valent pneumococcal conjugate vaccine safety and immunogenicity study of a 4-dose series in healthy infants. Pfizer. ClinicalTrials.gov identifier: NCT04382326. Updated November 3, 2022. Accessed April 20, 2023. https://beta.clinicaltrials.gov/study/NCT04382326.
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INDICATIONS 
  • Prevnar 20® is a vaccine 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
  • Both Prevnar 20® and Prevnar 13® are vaccines indicated for active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age
  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in individuals 6 weeks through 17 years of age
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine.
Important Safety Information
  • Do not administer Prevnar 20® or Prevnar 13® to individuals with a 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®
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and risks
  • For Prevnar 20®, in individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most commonly reported solicited adverse reactions (>10%) were irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever
  • For Prevnar 20®, in individuals 15 months through 17 years of age vaccinated with a single dose, the most commonly reported solicited adverse reactions (>10%) were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling, injection site redness, headache, and fever
  • For Prevnar 13®, in individuals 6 weeks through 17 years of age, the most commonly reported serious adverse events were bronchiolitis (0.9%), gastroenteritis (0.9%), and pneumonia (0.9%)
  • For Prevnar 13®, in individuals 6 weeks through 17 years of age, the most common side effects were irritability, decreased appetite, decreased or increased sleep, fever, and injection site tenderness, redness, or swelling
  • In individuals 6 years through 17 years of age, Prevnar 13® is administered as a single dose
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 a vaccine 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
  • Both Prevnar 20® and Prevnar 13® are vaccines indicated for active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age
  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in individuals 6 weeks through 17 years of age
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine.