13-Valent pneumococcal conjugate vaccine (PCV13) in children partially immunized with 7-valent pneumococcal conjugate vaccine (PCV7): a phase 3, open-label trial.

As 13-valent pneumococcal conjugate vaccine (PCV13) is introduced, children who began vaccination with 7-valent pneumococcal conjugate vaccine (PCV7) may complete their vaccination with PCV13. This open-label phase 3 study evaluated immunogenicity and safety of PCV13 in Swedish infants and toddlers previously given 1 or 2 doses of PCV7 during infancy. Healthy infants previously given PCV7 at ages 3 months (group 1; n=118) or 3 and 5 months (group 2; n=116) received PCV13 at ages 5 (group 1) and 12 months (both groups). IgG responses were assessed 1 month after each PCV13 dose and before the 12-month dose. Local reactions and systemic events were collected for 7 days postvaccination. Other adverse events were also collected. Post-5-month dose, IgG geometric mean concentrations (GMCs) in group 1 were 1.56-4.70 μg/ml for most PCV7 serotypes except 6B (0.40 μg/ml) and 23F (0.57 μg/ml) and 0.72-1.88 μg/ml for most of the 6 additional serotypes, except 6A (0.28 μg/ml). Post-12-month dose, IgG GMCs for the PCV7 serotypes were 2.93-9.63 μg/ml (group 1) and 3.33-9.30 μg/ml (group 2); and for the 6 additional serotypes, 1.85-14.65 μg/ml (group 1) and 1.34-13.16 μg/ml (group 2). GMCs increased by >4-fold in both groups from pre- to post-12-month dose. Proportions of subjects in group 1 with pneumococcal serotype-specific IgG concentrations ≥0.35 μg/ml (WHO-designated postprimary reference antibody level) post-5-month dose were 92.2-99.1% for most PCV7 serotypes except 6B (53.0%) and 23F (62.6%) and 80.9-100.0% for most of the 6 additional serotypes except 6A (36.8%). Local reactions and fever were mostly mild or moderate. PCV13 was immunogenic and safe in infants and toddlers previously partially immunized with PCV7. Even a single dose in an infant or toddler induces an immune response to the 6 additional serotypes. Copyright © 2013. Published by Elsevier Ltd.

Citation

Sven Arne Silfverdal, Carl-Erik Flodmark, Lars Rombo, Susan P Tansey, Mohinder Sidhu, James Trammel, Emilio A Emini, William C Gruber, Daniel A Scott, Alejandra Gurtman, 3012 study group. 13-Valent pneumococcal conjugate vaccine (PCV13) in children partially immunized with 7-valent pneumococcal conjugate vaccine (PCV7): a phase 3, open-label trial. Vaccine. 2013 Feb 18;31(9):1284-92

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PMID: 23306363

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