Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany

Abstract 13-valent pneumococcal conjugate vaccine (PCV13) was compared to PCV7 in infants administered 4 doses. For the 7 common serotypes, PCV13- and PCV7-elicited responses showed comparable percent responders achieving 0.35 μg/mL IgG threshold (exception 6B, 77.5% versus 87.1%, respectively) and...

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Bibliographic Details
Published in:Vaccine 2010-06, Vol.28 (25), p.4192-4203
Main Authors: Kieninger, Dorothee M, Kueper, Kathrin, Steul, Katrin, Juergens, Christine, Ahlers, Norbert, Baker, Sherryl, Jansen, Kathrin U, Devlin, Carmel, Gruber, William C, Emini, Emilio A, Scott, Daniel A
Format: Article
Language:English
Subjects:
13-valent pneumococcal conjugate vaccine
Age
Allergy and Immunology
Antibodies, Bacterial - blood
Applied microbiology
Bacteriology
Biological and medical sciences
Diphtheria
Double-Blind Method
Ear diseases
Female
Fundamental and applied biological sciences. Psychology
Germany
Heptavalent Pneumococcal Conjugate Vaccine
Humans
Immunization Schedule
Immunogenicity
Immunoglobulin G - blood
Infant
Male
Meningitis
Microbiology
Miscellaneous
Pneumococcal Infections - prevention & control
Pneumococcal Vaccines - adverse effects
Pneumococcal Vaccines - immunology
Pneumonia
Preschool children
Safety
Streptococcus infections
Streptococcus pneumoniae
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Vaccines, Conjugate - immunology
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Summary:Abstract 13-valent pneumococcal conjugate vaccine (PCV13) was compared to PCV7 in infants administered 4 doses. For the 7 common serotypes, PCV13- and PCV7-elicited responses showed comparable percent responders achieving 0.35 μg/mL IgG threshold (exception 6B, 77.5% versus 87.1%, respectively) and OPA titers of 1:8; IgGs were lower than PCV7 but functional responses were generally comparable. For the 6 additional serotypes, PCV13-elicited IgG and functional OPA responses were notably greater than PCV7. The toddler dose boosted immune responses. Vaccines were comparable with regard to safety. PCV13 should be as effective as PCV7 in preventing pneumococcal disease caused by the common serotypes and may provide protection against the additional serotypes.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2010.04.008