Immunogenicity

Antibody concentrations
After the fourth dose, antibody levels increased 4 to 15 times higher than prior to the fourth dose1*
Antibody concentrations chart
Antibody concentrations chart

*At 2, 4, 6, and 12 to 15 months of age. In children 6 years through 17 years of age, Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) is administered as a single dose.2

Pneumococcal antipolysaccharide lgG GMCs were calculated from blood samples taken from 252 infants and 239 toddlers who received a 4-dose series of Prevnar 13®.1

GMC=geometric mean concentration; lgG=immunoglobulin G.

Study description

Phase 3, double-blind, active-controlled, multicenter trial involving 666 infants randomized to receive 4 doses of Prevnar 13® (n=334) or Prevnar® (PCV7) (n=332) given at 2, 4, 6, and 12 to 15 months of age. A total of 294 infants in the Prevnar 13® group completed the first 3 doses, of which 252 were evaluable for immunogenicity. A total of 264 toddlers received the fourth dose of Prevnar 13®, of which 239 were evaluable for immunogenicity. Pneumococcal antipolysaccharide IgG GMCs were calculated from blood samples taken 1 month after the third dose, before the fourth dose, and 1 month after the fourth dose. The mean age at the fourth dose in this study was 12.4 months.1

Phase 3, double-blind, active-controlled, multicenter trial involving 666 infants randomized to receive 4 doses of Prevnar 13® (n=334) or Prevnar® (PCV7) (n=332) given at 2, 4, 6, and 12 to 15 months of age. A total of 294 infants in the Prevnar 13® group completed the first 3 doses, of which 252 were evaluable for immunogenicity.
A total of 264 toddlers received the fourth dose of Prevnar 13®, of which 239 were evaluable for immunogenicity. Pneumococcal antipolysaccharide IgG GMCs were calculated from blood samples taken 1 month after the third dose, before the fourth dose, and 1 month after the fourth dose. The mean age at the fourth dose in this study was 12.4 months.1

Among children, the highest rates of IPD occur in those under 2 years of age
Among children, the highest rates of IPD occur in those under 2 years of age
Prevnar 13® immunogenicity

Prevnar 13® effectiveness against IPD was inferred using comparative immunogenicity results from Prevnar® (PCV7).2

  • When measured 1 month following the third dose, the noninferiority criterion for immunogenicity was met for all serotypes except 6B, 9V, and 3. The differences for serotypes 6B and 9V were marginal. One month after the fourth dose, the noninferiority criterion for immunogenicity was met for all serotypes except serotype 3
  • Prevnar 13® elicited functional antibody responses for all 13 serotypes following the third and fourth doses
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein).
References:
  1. Yeh SH, Gurtman A, Hurley DC, et al; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010;126(3):e493-e505.
  2. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.
  3. Centers for Disease Control and Prevention. 2017. Active Bacterial Core surveillance report: Emerging Infections Program Network, Streptococcus pneumoniae, 2017. Available at: https://www.cdc.gov/abcs/reports-findings/survreports/spneu17.pdf. Published March 7, 2019. Accessed September 16, 2019.
References:
  1. Yeh SH, Gurtman A, Hurley DC, et al; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010;126(3):e493-e505.
  2. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.
  3. Centers for Disease Control and Prevention. 2017. Active Bacterial Core surveillance report: Emerging Infections Program Network, Streptococcus pneumoniae, 2017. Available at: https://www.cdc.gov/abcs/reports-findings/survreports/spneu17.pdf. Published March 7, 2019. Accessed September 16, 2019.