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.
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 0.35mug/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.
Kieninger
Dorothee M
DM
Arztin für Kinder- und Jugendmedizin, Zentrum für Kinder- und Jugendmedizin der Universitätsmedizin der Johannes Gutenberg-Universität Mainz KOR, Mainz, Germany. dorothee.kieninger@unimedizin-mainz.de
Kueper
Kathrin
K
Steul
Katrin
K
Juergens
Christine
C
Ahlers
Norbert
N
Baker
Sherryl
S
Jansen
Kathrin U
KU
Devlin
Carmel
C
Gruber
William C
WC
Emini
Emilio A
EA
Scott
Daniel A
DA
D000907:Antibodies, Bacterial / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007115:Immunization Schedule; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D008297:Male; D011008:Pneumococcal Infections / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000009:adverse effects / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000276:immunology
C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D007074:Immunoglobulin G; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate