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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
Safety ProfileDemonstrated safety profileThe safety profile of Prevnar 20 was evaluated in healthy infants and children aged 6 weeks to <15 months1Across three Phase 3 trials and one Phase 2 trial: Prevnar 20 safety profile was evaluated on both 3‑ and 4‑dose series1
  • Prevnar 20 demonstrated low rates of severe local reactions and systemic events in infant studies
  • Most reactions resolved within 1 to 3 days
The frequency and severity of the adverse reactions in all infant clinical trials were generally similar in the Prevnar 20 and Prevnar 13 groupsAdverse reactionsThe most frequently reported local reactions and systemic events after any dose of Prevnar 20 were irritability, drowsiness, and pain at injection site.1

3-Dose Series

4-Dose Series

Tab Number 3

Tab Number 4

Tab Number 5

Solicited adverse reactions within 7 days of each dose in infants receiving a 3‑dose series
Scroll left to view table
  Dose 1 Dose 2
 
Prevnar 20
  (N=598)
%
 Prevnar 13
(N=603)

%		 Prevnar 20 (N=592)
%		 Prevnar 13 (N=594)
%
Local Reaction
Pain at injection site 29.1 29.4 22.8 24.6
Redness 25.3 27.5 58.5 28.1
Swelling 21.4 20.2 22.2 20.5
Systemic Event
Irritability 71.9 72.5 71.6 68.4
Drowsiness 61.2 63.7 51.4 50.7
Decreased appetite 24.7 22.6 24.7 19.4
Fever (≥38.0 ºC) 8.9 8.5 14.9 14.0
Scroll left to view table
  Dose 3 (Toddler Dose)
  Prevnar 20
(N=580)
%		 Prevnar 13
(N=586)
%
Local Reaction
Pain at injection site 42.4 39.9
Redness 36.9 33.8
Swelling 29.8 24.6
Systemic Event
Irritability 71.0 70.8
Drowsiness 50.9 48.6
Decreased appetite 39.3 36.5
Fever (≥38.0 ºC) 24.3 23.7
Solicited adverse reactions within 7 days of each dose in infants receiving a 4-dose series
Scroll left to view table
  Dose 1 Dose 2
  Prevnar 20
  (N=2,214)
%		 Prevnar 13
(N=1,696)

%		 Prevnar 20 (N=2,107)
%		 Prevnar 13 (N=1,613)
%
Local Reaction
Pain at injection site 45.5 45.4 38.6 39.9
Redness 23.8 23.2 23.5 25.7
Swelling 17.6 17.6 16.7 18.0
Systemic Event
Irritability 70.6 71.5 68.4 69.9
Drowsiness 66.2 65.6 52.4 54.1
Decreased appetite 24.8 24.7 24.9 23.1
Fever (≥38.0 ºC) 10.3 8.5 16.5 15.7
Scroll left to view table
  Dose 3 Dose 4 (Toddler Dose)
  Prevnar 20 (N=2,055)
%		 Prevnar 13 (N=1,582)
%		 Prevnar 20 (N=1,904)
%		 Prevnar 13 (N=1,454)
%
Local Reaction
Pain at injection site 32.8 35.5 33.4 34.6
Redness 24.5 25.0 22.6 25.6
Swelling 16.8 17.5 15.1 16.0
Systemic Event
Irritability 60.8 61.4 58.5 59.4
Drowsiness 39.8 41.9 37.7 38.1
Decreased appetite 23.0 22.3 26.4 25.9
Fever (≥38.0 ºC) 12.7 13.1 16.0 15.0
Prevnar 20 can be co-administered with routine pediatric vaccinesThe safety profile of Prevnar 20 was acceptable, and similar to Prevnar 13 when administered concomitantly with routine pediatric vaccines containing diphtheria, tetanus, acellular pertussis, hepatitis B virus, poliovirus, and Haemophilus influenzae type b antigens; measles, mumps, and rubella antigens; and varicella antigens.Reference:Prevnar 20™ Product Monograph. Pfizer Canada ULC.About NEXT

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