Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan
Journal
Vaccine
Journal Volume
30
Journal Issue
12
Pages
2054-2059
Date Issued
2012
Author(s)
Abstract
Immunogenicity and safety of 13-valent and 7-valent pneumococcal conjugate vaccines (PCV13; PCV7) were compared in Taiwanese children.In this double-blind, multicenter study, healthy children were randomly assigned to receive PCV13 (n= 84) or PCV7 (n= 84) at 2, 4, 6 and 15 months with routine pediatric vaccines.For the 7 PCV13/PCV7 common serotypes, serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) were high 1 month postinfant series, with ?95.0% in both groups achieving IgG levels ?0.35 μg/mL, with a trend to lower IgG GMCs for PCV13 compared with PCV7 (PCV13:PCV7 GMC ratios 0.59-0.91). For the 6 additional serotypes unique to PCV13, GMCs were notably higher after PCV13 than PCV7 (PCV13:PCV7 GMC ratios 1.50-202.58). Immune responses generally increased posttoddler dose. Safety was similar between groups.PCV13 was safe and immunogenic in this Taiwanese population. PCV13 should offer broader protection than PCV7 against pneumococcal disease.Clinical trials registration number: NCT00688870. ? 2012 Elsevier Ltd.
Subjects
Immunogenicity; PCV13; PCV7; Safety; Streptococcus pneumoniae
SDGs
Other Subjects
7 valent pneumococcal conjugate vaccine; antipyretic agent; immunoglobulin G; Pneumococcus vaccine; unclassified drug; anorexia; article; controlled study; dose response; double blind procedure; drug safety; drug withdrawal; female; fever; human; immune response; immunogenicity; immunoglobulin blood level; infant; irritability; major clinical study; male; multicenter study; pneumococcal infection; priority journal; randomized controlled trial; serotype; side effect; skin manifestation; skin redness; skin swelling; sleep disorder; Taiwan; unspecified side effect; vaccination; Antibodies, Bacterial; Double-Blind Method; Female; Humans; Immunoglobulin G; Infant; Infant, Newborn; Male; Pneumococcal Infections; Pneumococcal Vaccines; Taiwan
Type
journal article