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

• Published in: Vaccine Vol. 31; no. 9; pp. 1284 - 1292
• Main Authors: Silfverdal, Sven Arne, Flodmark, Carl-Erik, Rombo, Lars, Tansey, Susan P., Sidhu, Mohinder, Trammel, James, Emini, Emilio A., Gruber, William C., Scott, Daniel A., Gurtman, Alejandra
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 18.02.2013; Elsevier; Elsevier Limited
• Subjects: 13-Valent pneumococcal conjugate vaccine; 2 + 1 Schedule; Age; Allergy and Immunology; Antibodies, Bacterial - blood; Applied microbiology; Bacteriology; Basic Medicine; Biological and medical sciences; children; Clinical Medicine; Confidence intervals; Documentation; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - pathology; Ear diseases; Fever; Fundamental and applied biological sciences. Psychology; Heptavalent Pneumococcal Conjugate Vaccine; Humans; immune response; Immunization; Immunogenicity; immunoglobulin G; Immunoglobulin G - blood; Immunologi inom det medicinska området; Immunologi inom det medicinska området (Här ingår: Cell- och immunterapi); Immunology in the medical area; Immunology in the Medical Area (including Cell and Immunotherapy); infancy; Infant; Infants; Klinisk medicin; Läkemedelskemi; Medical and Health Sciences; Medicin och hälsovetenskap; Medicinal Chemistry; Medicinska och farmaceutiska grundvetenskaper; Microbiology; Miscellaneous; PCV13; Pediatric; Pediatrics; Pediatrik; Pneumococcal Infections - prevention & control; Pneumococcal Vaccines - administration & dosage; Pneumococcal Vaccines - adverse effects; Pneumococcal Vaccines - immunology; Preschool children; Safety; serotypes; Sleep; Streptococcus infections; Streptococcus pneumoniae; Sweden; toddlers; vaccination; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Sweden; PCV13; GMFR; NIP; Immunogenicity; 2+1 Schedule; IgG; 13-Valent pneumococcal conjugate vaccine; Safety; GMC; IPD; Pediatric; geometric mean concentration; immunoglobulin G; invasive pneumococcal diseases; geometric mean fold rise; 2 + 1 Schedule; national immunization program; Human; Immunization; Vaccine; Streptococcus pneumoniae; Streptococcaceae; Bacteria; Micrococcales; Child
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2012.12.066

► In Sweden, pneumococcal conjugate vaccine (PCV) is administered on a 2+1 schedule. ► Infants who had 1 or 2 infant doses of PCV7 completed their schedule with PCV13. ► IgG GMCs increased by >4-fold for all serotypes from pre- to post-12-month dose. ► PCV13 was safe and well tolerated. ► Even a single dose of PCV13 induces immune responses to the 6 additional serotypes. 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 1.56–4.70μg/ml for most PCV7 serotypes except 6B (0.40μg/ml) and 23F (0.57μg/ml) and 0.72–1.88μg/ml for most of the 6 additional serotypes, except 6A (0.28μg/ml). Post-12-month dose, IgG GMCs for the PCV7 serotypes were 2.93–9.63μg/ml (group 1) and 3.33–9.30μg/ml (group 2); and for the 6 additional serotypes, 1.85–14.65μg/ml (group 1) and 1.34–13.16μg/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 ≥0.35μg/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.