A phase 3, randomized, double-blind trial comparing the safety and immunogenicity of the 7-valent and 13-valent pneumococcal conjugate vaccines, given with routine pediatric vaccinations, in healthy infants in Brazil

A phase 3, randomized, double-blind trial comparing the safety and immunogenicity of the 7-valent and 13-valent pneumococcal conjugate vaccines, given with routine pediatric vaccinations, in healthy infants in Brazil

Author Weckx, Lily Yin Autor UNIFESP Google Scholar
Thompson, Allison Google Scholar
Berezin, Eitan Naaman Google Scholar
Faria, Sonia Maria de Google Scholar
Cunha, Clovis Arns da Google Scholar
Pride, Michael Google Scholar
Patterson, Scott Google Scholar
Gruber, William C. Google Scholar
Emini, Emilio A. Google Scholar
Scott, Daniel A. Google Scholar
012 Study Grp Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Pfizer Inc
Fac Ciencias Med Santa Casa São Paulo
Universidade Federal de Santa Catarina (UFSC)
Hosp Infantil Joana de Gusmao
Univ Fed Parana
Abstract Background: the inclusion of 7-valent pneumococcal conjugate vaccine (PCV7) into national immunization programs in many countries has significantly decreased the incidence of disease caused by Streptococcus pneumoniae. However, a substantial portion of disease remained and, in some areas, there has been an increase in disease produced by serotypes not included in PCV7. A 13-valent pneumococcal conjugate vaccine (PCV13) was studied in healthy Brazilian infants in a phase 3, double-blind, randomized study.Methods: Infants were randomized to receive either PCV7 or PCV13 at 2, 4, 6, (doses 1-3), and 12 (toddler dose) months of age, along with routine pediatric vaccinations (diphtheria, tetanus, whole-cell pertussis, and Haemophilus influenzae type b vaccine). Pneumococcal anticapsular polysaccharide-binding immunoglobulin G (IgG) responses and antibody responses to pertussis antigens were measured 1 month after both dose 3 of the infant series and the toddler dose. Safety and tolerability were also assessed.Results: the proportion of subjects achieving a serotype-specific IgG concentration >= 0.35 mu g/mL measured 1 month after the infant series was comparable in the PCV13 (>= 94.2%) and PCV7 (>= 93.0%) groups for the 7 serotypes common to both vaccines. the percentage of responders for the 6 additional serotypes ranged from 87.1 to 100% for PCV13. the percentage of responders varied across the pertussis antigens studied, but was not different in PCV13 and PCV7 recipients. Overall, the safety profile of PCV13 was comparable with that of PCV7.Conclusions: PCV13 was comparable to PCV7 in safety and tolerability, elicited comparable immune responses to the common serotypes, and did not interfere with immune responses to concomitantly administered whole-cell pertussis vaccine. the robust immunogenicity exhibited by PCV13 for the additional serotypes suggests that it could provide significant protection against these serotypes. (C) 2012 Published by Elsevier B.V.
Keywords Pneumococcal conjugate vaccine
Safety
Immunogenicity
Brazil
Whole-cell pertussis vaccine
Language English
Sponsor Wyeth
Pfizer Inc.
Date 2012-12-14
Published in Vaccine. Oxford: Elsevier B.V., v. 30, n. 52, p. 7566-7572, 2012.
ISSN 0264-410X (Sherpa/Romeo, impact factor)
Publisher Elsevier B.V.
Extent 7566-7572
Origin http://dx.doi.org/10.1016/j.vaccine.2012.10.040
Access rights Closed access
Type Article
Web of Science ID WOS:000312974800019
URI http://repositorio.unifesp.br/handle/11600/35613

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