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About Prevenar 20™ at a Glance Serotype Coverage Pneumococcal Disease Clinical Programme RecommendationsPractical Use Resources
Clinical studies demonstrated a robust immune response against 20 serotypes1Multiple endpoints were evaluated that assessed important aspects of immunity1,2

To assess new pneumococcal conjugate vaccines (PCVs), multiple immunologic assessments are considered to help infer how effective the vaccines may be in real-world use.3​​​​​​​

 Roles of key immunologic assessments

GMC=geometric mean concentration; GMT=geometric mean titre; IgG=immunoglobulin G; OPA=opsonophagocytic activity.

The totality of data show that a 4-dose series of Prevenar 20™ induced an immune response expected to provide protection similar to Prevenar 13® (Pneumococcal 13-valent Conjugate Vaccine) for the shared serotypes while expanding protection against 7 additional serotypes.1

Prevenar 20™ phase 3 pivotal study design

Randomised, active-controlled, double-blind noninferiority trial in the United States and Puerto Rico. A total of 1988 babies were randomised 1:1 to receive a 4-dose series of either Prevenar 20™ (0.5 mL intramuscular injection) or Prevenar 13® (0.5 mL intramuscular injection) at 2, 4, 6, and 12 to 15 months of age. Participants received concomitant vaccines with each dose.1,2,7

Example

DTaP=diphtheria, tetanus, acellular pertussis vaccine; HepB=hepatitis B; Hib=Haemophilus influenzae type b; IPV=inactivated poliovirus vaccine; MMR=measles, mumps, rubella vaccine.

Prevenar 20™ elicited a robust immune response against 20 serotypes after [__] doses1Primary study endpoints assessed antibody production1,2
  • Safety of Prevenar 20™ compared to safety of Prevenar 13®1
  • IgG GMCs 1 month after Dose 41
    • Prevenar 20™ was noninferior to Prevenar 13® for all 20 serotypes
  • Percentage of babies reaching prespecified IgG concentrations 1 month after Dose 31*

    • Prevenar 20™ was noninferior to Prevenar 13® for 15 serotypes†
Threshold was originally established based on concentrations 1 month after a 3-dose primary series.3Noninferiority was achieved for serotypes 1, 5, 6A, 6B, 7F, 8, 10A, 11A, 14, 15B, 18C, 19A, 19F, 22F, and 33F.1Secondary study endpoints assessed antibody production and subsequent functional antibodies produced1,2Key Secondary Endpoint1,2
  • IgG GMCs 1 month after Dose 31
    • Prevenar 20™ was noninferior to Prevenar 13® for all 20 serotypes
Additional Secondary Endpoints1,2
  • Percentage of babies reaching prespecified IgG concentrations 1 month after Dose 41
    • Noninferiority was not formally tested for this endpoint
  • OPA GMTs 1 month after Dose 3 and 1 month after Dose 41
    • Prevenar 20™ induced functional antibodies capable of killing pneumococcal bacteria for all 20 serotypes following the third and fourth doses

Clinical significance of differences in immunogenicity data is unknown.

Select a measure to view results compared to Prevenar 13®.

Antibody production

Antibody prespecified levels (%)

Functional response

 Memory response

Tab Number 5

Clinical significance of differences in immunogenicity data is unknown.

Noninferiority for a matched serotype was concluded if the lower bound of the 2-sided 95% CI for the GMC ratio (Prevenar 20™-Prevenar 13®) was >0.5 for that serotype. The 7 additional serotypes were compared to the GMC ratio of the lowest response from Prevenar 13® (serotype 1), excluding serotype 3.1Specified levels for the Prevenar 13® serotypes are from a published bridging study (Tan CY, et al, 2018) using results from after primary infant doses, before toddler dose, and after toddler dose (schedule of 3 infant doses followed by a toddler dose) except for serotype 19A, which used results from after primary infant doses only. For the additional 7 serotypes, specified levels are from a concordance evaluation (clinical dLIA to retest ELISA) of data from a phase 2 study (B7471003), which also uses the schedule of 3 infant doses followed by a toddler dose.1Noninferiority for a particular serotype was declared if the lower bound of the 2-sided 95% CI for the percentage difference (Prevenar 20™-Prevenar 13®) was >-10%.1OPA titres were determined on serum from randomly selected subsets of participants ensuring equal representation of both vaccine groups.7CI=confidence interval; dLIA=Luminex-based direct immunoassay; ELISA=enzyme-linked immunosorbent assay.Prevenar 20™ demonstrated a safety profile consistent with Prevenar 13®1
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Study conducted in the United States, including Puerto Rico.1Local reactions, systemic reactions, and use of antipyretic/pain medication were collected in the e-diary from Day 1 through Day 7 after each dose. If a severe reaction was identified by the investigator as a Grade 4 reaction at a follow-up assessment, it was also reported as an adverse event.2Any local reaction: any redness >0.0 cm, any swelling >0.0 cm, or any pain at the injection site after the specified dose.2Any systemic reaction: any fever ≥38.0°C, any decreased appetite, any drowsiness, or any irritability after the specified dose.2N=number of participants with any e-diary data reported after the specified dose. This value is the denominator for the percentage calculations.2
Nearly 300 million babies have been vaccinated with Prevenar§§ vaccines globally.11
Prevenar includes Prevenar® (Pneumococcal 7-valent Conjugate Vaccine) and Prevenar 13®. In [Country], Prevenar® (PCV7) was available from 2001 to 2010, and Prevenar 13® has been available since 2010.12,13,15 See [Local body] recommendations and dosing LoadingReferences:Prevenar 20™ (Pneumococcal 20-valent Conjugate Vaccine). Summary of Product Characteristics. Wyeth Pharmaceuticals LLC; 2024.20-valent pneumococcal conjugate vaccine safety and immunogenicity study of a 4-dose series in healthy infants. ClinicalTrials.gov identifier: NCT04382326. Updated December 6, 2023. Accessed January 30, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT04382326.Siber GR, Chang I, Baker S, et al. Estimating the protective concentration of anti-pneumococcal capsular polysaccharide antibodies. Vaccine. 2007;25(19):3816-3826.World Health Organization (WHO) Expert Committee on Biological Standardization. Annex 3: Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines. Updated October 19, 2013. Accessed March 17, 2023. https://cdn.who.int/media/docs/default-source/biologicals/vaccine-standardization/pneumococcus/trs_977_annex_3.pdf?sfvrsn=344f81e_3&download=true.Westerink MA, Schroeder HW Jr, Nahm MH. Immune responses to pneumococcal vaccines in children and adults: rationale for age-specific vaccination. Aging Dis. 2012;3(1):51-67.Clutterbuck EA, Salt P, Oh S, Marchant A, Beverley P, Pollard AJ. The kinetics and phenotype of the human B-cell response following immunization with a heptavalent pneumococcal-CRM197 conjugate vaccine. Immunology. 2006;119(3):328-337.Data on file. Pfizer Inc., New York, NY.Janeway CA Jr, Travers P, Walport M, Shlomchik MJ. Immunological memory. In: Immunobiology: The Immune System in Health and Disease. 5th ed. Garland Science; 2001. https://www.ncbi.nlm.nih.gov/books/NBK27158/.Papadatou I, Tzovara I, Licciardi PV. The role of serotype-specific immunological memory in pneumococcal vaccination: current knowledge and future prospects. Vaccines (Basel). 2019;7(1):13.Pichichero ME. Recurrent and persistent otitis media. Pediatr Infect Dis J. 2000;19(9):911-916.Chapman R, Sutton K, Dillon-Murphy D, et al. Ten year public health impact of 13-valent pneumococcal conjugate vaccination in infants: a modelling analysis. Vaccine. 2020;38(45):7138-7145.Prevenar 13® (Pneumococcal 13-valent Conjugate Vaccine). Summary of Product Characteristics. Wyeth Pharmaceuticals LLC; 2014.Prevenar® (Pneumococcal 7-valent Conjugate Vaccine). Summary of Product Characteristics. Wyeth Pharmaceuticals LLC; 2011.Centers for Disease Control and Prevention. ACIP updates: recommendations for the use of 20-valent pneumococcal conjugate vaccine in children—United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(39):1072. https://stacks.cdc.gov/view/cdc/133252.Local approval dates.
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[Local body] recommends Prevenar 20™ for routine infant vaccination14 Learn more Loading
PP-PNR-GLB-0425 March 2024

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