Session Title: VACCINE AND PREVENTION
SAFETY AND IMMUNOGENICITY OF A 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH ROUTINE PEDIATRIC VACCINATION TO HEALTHY CHILDREN IN FRANCE
E. Grimprel1, F. Laudat2, S.A. Baker3, C. Sekaran3, W.C. Gruber3, D.A. Scott3
1Groupe Hospitalier Armand-Trousseau - La Roche-Guyon, 2Wyeth Vaccines Research, Paris, France, 3Wyeth Vaccines Research, Pearl River, USA
Background: A 13-valent pneumococcal conjugate vaccine (PCV13;CRM197 conjugated to pneumococcal serotypes 1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F,23F,Wyeth) has been developed to broaden coverage for prevention of invasive pneumococcal diseases compared with licensed 7-valent pneumococcal vaccine (PCV 7; Prevenar® Wyeth).
Objectives: Safety and immunogenicity of PCV13 booster given as part of a 3+1 (2,3,4,12 months) vaccination schedule.
Methods: Subjects were randomly assigned (2:1:1 ratio) to receive either 4 doses of PCV13, 4 of PCV7, or 3 of PCV7 followed by 1 dose of PCV13 concomitantly with DTaP-IPV/Hib at 2, 3, 4 and 12 months of age. Antibody responses to PCV13 were measured at 13 months. Reactogenicity and adverse events were assessed.
Results: Of 613 randomized subjects, 495 (PCV13/PCV13; n=241; PCV7/PCV7, n=133; PCV7/PCV13, n=121) were evaluable for immunogenicity after 12-month dose. For the 7 common serotypes, IgG GMCs were similar in all groups. IgG GMCs among additional serotypes ranged from 0.99 µg/mL (3) to 9.50 (19A) in PCV13/PCV13 recipients, and from 1.14 µg/mL (5) to 5.33 (19A) in PCV7/PCV13 recipients. GMCs were higher for 5 serotypes (not serotype 3) in PCV13/PCV13 recipients, vs. PCV7/PCV13. GMCs for the 6 additional serotypes were higher in PCV13 recipients vs. PCV7/PCV7.
Conclusions: One dose of PCV13 booster, given at 12 months of age in children primed with PCV7, induced a robust antibody response to all 13 pneumococcal vaccine serotypes, as did a 4-dose series of PCV13. Higher GMCs to the 6 additional serotypes in the 13vPnC/13vPnC group is consistent with establishing memory from infant series vaccination.
For P.C.V. Multicenter Study Groups, Paris, France