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Home20 Serotypes20 SerotypesSerotype coverageCase CoverageDisease BurdenEfficacyEfficacyInvasive Pneumococcal DiseaseOtitis MediaClinical Trial Results

Clinical Trial
Results

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Phase 3 pivotal study1,2Phase 3 pivotal study1,2A randomized, active-controlled, double-blind noninferiority trial compared to Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])A randomized, active-controlled, double-blind noninferiority trial compared to Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])A randomized, active-controlled, double-blind noninferiority trial compared to Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])A randomized, active-controlled, double-blind noninferiority trial compared to Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])

1997 babies in the United States and Puerto Rico were randomized 1:1 to receive a 4-dose series of either Prevnar 20® (0.5 mL intramuscular injection) or Prevnar 13® (0.5 mL intramuscular injection) at 2, 4, 6, and 12 to 15 months of age. Participants received concomitant vaccines with each dose, according to the CDC-recommended schedule.

1997 babies in the United States and Puerto Rico were randomized 1:1 to receive a 4-dose series of either Prevnar 20® (0.5 mL intramuscular injection) or Prevnar 13® (0.5 mL intramuscular injection) at 2, 4, 6, and 12 to 15 months of age. Participants received concomitant vaccines with each dose, according to the CDC-recommended schedule.

Primary Endpoints

Secondary Endpoints

   Primary endpoints3
  • Safety of Prevnar 20® compared to safety of Prevnar 13®1
  • IgG GMCs 1 month after Dose 41
    • Prevnar 20® achieved noninferiority to Prevnar 13® for all 13 matched serotypes. All 7 additional serotypes were noninferior to the lowest IgG GMC (serotype 1) among the vaccine serotypes, excluding serotype 3, in the Prevnar 13® group 
  • Percentage of babies reaching prespecified IgG concentrations 1 month after Dose 31 
    • Prevnar 20® was noninferior to Prevnar 13® for 8 of the 13 matched serotypes: serotypes 1, 4, 9V, and 23F missed statistical noninferiority by small margins and serotype 3 missed by a wider margin. Six of the 7 additional serotypes met the noninferiority criterion, with serotype 12F missing statistical noninferiority

Primary endpoints3

  • Safety of Prevnar 20® compared to safety of Prevnar 13®1
  • IgG GMCs 1 month after Dose 41
    • Prevnar 20® achieved noninferiority to Prevnar 13® for all 13 matched serotypes. All 7 additional serotypes were noninferior to the lowest IgG GMC (serotype 1) among the vaccine serotypes, excluding serotype 3, in the Prevnar 13® group 
  • Percentage of babies reaching prespecified IgG concentrations 1 month after Dose 31 
    • Prevnar 20® was noninferior to Prevnar 13® for 8 of the 13 matched serotypes: serotypes 1, 4, 9V, and 23F missed statistical noninferiority by small margins and serotype 3 missed by a wider margin. Six of the 7 additional serotypes met the noninferiority criterion, with serotype 12F missing statistical noninferiority

Selected secondary endpoints3

  • IgG GMCs 1 month after Dose 31 
    • Prevnar 20® achieved noninferiority to Prevnar 13® for all 13 matched serotypes and for all 7 additional serotypes in the Prevnar 13® group as measured by mean IgG concentrations post Dose 3
  • OPA GMTs 1 month after Dose 3 and 1 month after Dose 41
    • Prevnar 20® elicited functional antibodies capable of killing pneumococcal bacteria for all 20 serotypes following the third and fourth doses

Selected secondary endpoints3

  • IgG GMCs 1 month after Dose 31 
    • Prevnar 20® achieved noninferiority to Prevnar 13® for all 13 matched serotypes and for all 7 additional serotypes in the Prevnar 13® group as measured by mean IgG concentrations post Dose 3
  • OPA GMTs 1 month after Dose 3 and 1 month after Dose 41                                                   
    • Prevnar 20® elicited functional antibodies capable of killing pneumococcal bacteria for all 20 serotypes following the third and fourth doses
CDC=Centers for Disease Control and Prevention; DTaP=diphtheria, tetanus, acellular pertussis vaccine; GMC=geometric mean concentration; GMT=geometric mean titer; HepB=hepatitis B; Hib=Haemophilus influenzae type b; IgG=immunoglobulin G; IPV=inactivated poliovirus vaccine; MMR=measles, mumps, rubella vaccine; OPA=opsonophagocytic activity.CDC=Centers for Disease Control and Prevention; DTaP=diphtheria, tetanus, acellular pertussis vaccine; GMC=geometric mean concentration; GMT=geometric mean titer; HepB=hepatitis B; Hib=Haemophilus influenzae type b; IgG=immunoglobulin G; IPV=inactivated poliovirus vaccine; MMR=measles, mumps, rubella vaccine; OPA=opsonophagocytic activity.
See the immunogenicity data for Prevnar 20® compared to Prevnar 13®
LoadingReferences:Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2023. Watson W. 20-Valent pneumococcal conjugate vaccine (PCV20) phase 3 in pediatrics. Presented at: Advisory Committee on Immunization Practices; February 22-24, 2023; Atlanta, GA. Accessed April 21, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-02/slides-02-22/Pneumococcal-04-Watson-508.pdf.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.