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About Prevnar 20About Prevnar 2020 SerotypesMechanism of actionImmunogenicity profileSafety profileDosing and administrationDosing and administrationDosingAdministrationInvasive pneumococcal diseaseInvasive pneumococcal diseaseDisease burden in infants and childrenSerotype distributionGuidelinesResourcesResourcesMaterialsVideos
Safety InformationProduct MonographPrevnar 20 Adult
Immunogenicity profileInfant Immune Responses

3-Dose Series

4-Dose Series

601 healthy infants* received Prevnar 20 in a 3-dose series1†‡

One month after the third (toddler) dose:

  • The observed IgG geometric mean concentrations (GMCs) of Prevnar 20 were non-inferior to Prevnar 13 group for 12 of 13 matched serotypes except for serotype 6B
  • All 7 additional serotypes were noninferior to the lowest IgG GMC in the Prevnar 13 group
  • Additionally, the IgG GMCs for the 7 additional serotypes in Prevnar 20 were higher compared with the IgG GMCs from the corresponding serotypes in the Prevnar 13 group after the toddler dose
Increases in IgG and OPA antibody responses after Prevnar 20 following Dose 2 to after Dose 3 were observed for all 20 serotypes including those that missed noninferiority, indicative of immunological memory.IgG: immunoglobulin GTwo months of age (≥42 to ≤112 days) and born at >36 weeks of gestation.Participants were randomized (1:1) to receive either Prevnar 20 (n=601) or Prevnar 13 (n=603) with the first dose given at 42 to 112 days of age, a second dose given approximately 2 months later, and the third dose given at approximately 11 to 12 months of age.Comparative clinical significance is unknown.
1000 healthy infants* received Prevnar 20 in a 4-dose series1†

One month after Dose 3:

  • Prevnar 20 was noninferior to Prevnar 13 in 8 of the 13 serotypes based on a 10% noninferiority criteria‡
  • Serotypes 1, 3, 4, 9V and 23F did not meet the pre-specified noninferiority criteria, as the lower bounds of the 2-sided 95% CIs for the difference in percentages (Prevnar 20 minus Prevnar 13) were below -10%‡
  • Six of the 7 additional serotypes met noninferiority criterion‡
  • Serotype 12F missed the statistical noninferiority criteria‡
  • The IgG GMC for Prevnar 20 were noninferior for all 13 matched serotypes to Prevnar 13, as well as all 7 additional serotypes vs. the lowest IgG GMC among Prevnar 13 serotypes‡
Immunogenicity profile after dose 3 of a 4-dose series
Scroll left to view table
  Percentages of participants with predefined IgG concentrations§ IgG GMCs
  Prevnar 20
N =
831-833		 Prevnar 13
N =
801-802		 Prevnar 20 – Prevnar 13 Prevnar 20
N=
831-833		 Prevnar 13
N=
801-802		 Prevnar 20/
Prevnar 13
  % % % (95% CI**) GMC†† GMC†† GMR
(95% CI††)
Serotypes
1 79.8 88.4 −8.6
(−12.1, −5.1)		 0.74 1.14 0.65
(0.59, 0.72)
3 52.1 67.6 −15.5
(−20.1, −10.8)		 0.36 0.51 0.70
(0.64, 0.76)
4 79.7 88.2 −8.4
(−12.0, −4.9)		 0.75 1.08 0.70
(0.63, 0.78)
5 82.5 86.8 −4.3
(−7.8, −0.8)		 0.66 0.96 0.69
(0.61, 0.77)
6A 93.5 95.9 −2.4
(−4.6, −0.2)		 1.95 2.69 0.72
(0.65, 0.81)
6B 88.3 92.4 −4.1
(−7.0, −1.2)		 0.61 1.02 0.60 (0.51, 0.70)
7F 96.6 97.6 −1.0
(−2.7, 0.7)		 1.71 2.29 0.75
(0.69, 0.81)
9V 81.9 89.8 −7.9
(−11.3, −4.6)		 0.87 1.21 0.72
(0.65, 0.80)
14 93.4 94.1 −0.8
(−3.1, 1.6)		 2.16 2.72 0.79
(0.71, 0.89)
18C 92.6 93.1 −0.6
(−3.1, 1.9)		 1.31 1.71 0.77
(0.70, 0.84)
19A 97.1 98.1 −1.0
(−2.6, 0.5)		 0.72 0.91 0.79
(0.72, 0.86)
19F 96.9 96.6 0.2
(−1.5, 2.0)		 1.59 2.00 0.79
(0.73, 0.86)
23F 77.9 85.5 −7.6
(−11.4, -3.9)		 0.82 1.25 0.66
(0.58, 0.75)
Additional Serotypes††
8 8 96.8 ‡‡ 1.80 ‡‡ 1.98
(1.81, 2.16)
10A 10A 82.2 ‡‡ 1.21 ‡‡ 1.32
(1.18, 1.49)
11A 11A 92.7 ‡‡ 1.39 ‡‡ 1.52
(1.39, 1.67)
12F 12F 67.5 ‡‡ 0.55 ‡‡ 0.60
(0.54, 0.67)
15B 15B 98.2 ‡‡ 4.40 ‡‡ 4.82
(4.39, 5.30)
22F 22F 98.3 ‡‡ 3.71 ‡‡ 4.06
(3.68, 4.48)
33F 33F 86.7 ‡‡ 1.49 ‡‡ 1.64
(1.46, 1.83)
IgG: immunoglobulin GStudy 1011 was conducted in the United States and the territory of Puerto Rico (NCT04382326).Comparative clinical significance is unknown.Noninferiority for a serotype was concluded if the lower bound of the 2-sided 95% CI for the percentage difference (Prevnar 20 – Prevnar 13) was >-10% or the lower bound of the 2-sided 95% CI for the geometric mean ratio (Prevnar 20 to Prevnar 13) was >0.5 for that serotype.The predefined IgG concentration was ≥0.35 mcg/mL for all serotypes except for serotypes 5, 6B and 19A which were ≥0.23 mcg/mL, ≥0.10 mcg/mL and ≥0.12 mcg/mL respectively.N = Number of participants with valid IgG concentrations.Two-sided CI based on the Miettinen and Nurminen method.GMCs, GMRs and the associated 2-sided CIs were calculated by exponentiating the means and the mean differences (Prevnar 20 – Prevnar 13) of the logarithm of the concentrations and the corresponding Cis (based on the Student’s t distribution).For the geometric mean ratios and the percentage differences of the 7 additional serotypes, the IgG results from serotype 19A and 23F (vaccine serotype with the lowest GMC and percentage, excluding serotype 3) in the Prevnar 13 group was used in the comparisons the IgG GMCs to serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F in the Prevnar 13 group were 1.6%, 1.2%, 1.5%, 0.1%, 2.6%, 0.9% and 1.1%, respectively.
Reference:Prevnar 20™ Product Monograph. Pfizer Canada ULC.About NEXT

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