TY - JOUR
T1 - Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers
T2 - A randomized, controlled, open-label, multicenter study
AU - Chatterjee, Archana
AU - O'Keefe, Catherine
AU - Varman, Meera
AU - Klein, Nicola P.
AU - Luber, Stephen
AU - Tomovici, Antigona
AU - Noriega, Fernando
N1 - Funding Information:
Funding: This study was funded by Sanofi Pasteur Inc., Sanofi Pasteur designed the study protocol and provided logistical support during the trial. The initial manuscript was prepared by Dr. Chatterjee and comments from the other authors were incorporated. Sanofi Pasteur reviewed the manuscript and suggested changes, but the final decision on content was exclusively retained by the authors.
Copyright:
Copyright 2012 Elsevier B.V., All rights reserved.
PY - 2012/5/14
Y1 - 2012/5/14
N2 - Background: Pentavalent and quadrivalent combination vaccine formulations from the same manufacturer (DTaP-IPV/Hib [PENTA], DTaP-IPV [QUAD]) were investigated as to whether they were sufficiently interchangeable to tailor use to local preference or availability. Methods: A randomized, controlled, open-label, 4-armed, multicenter study in healthy, full-term infants (42-89 days of age) was conducted in 38 centers across the United States. Participants were randomized 1:1:1:1 to a control vaccine group (3 doses DTaP, IPV, and Hib and at Dose 4 DTaP and Hib) and 3 combination vaccine groups: (1) 3 doses PENTA, then Dose 4 DTaP and Hib; (2) 4 QUAD doses and Hib; (3) 4 PENTA doses. Participants (. N=. 2167) were immunized at 2, 4, and 6 months of age, Dose 4 participants (. N=. 1832) at 15 months of age. Immunogenicity was assessed before Doses 1 and 4 and after Doses 3 and 4. Safety was assessed 30 days after each dose and through 180 days Post-Dose 4. Results: Antibody responses and geometric mean concentrations/geometric mean titers (GMCs/GMTs) elicited by each combination vaccine were noninferior (upper-bound 90% confidence interval of GMC/GMT ratios
AB - Background: Pentavalent and quadrivalent combination vaccine formulations from the same manufacturer (DTaP-IPV/Hib [PENTA], DTaP-IPV [QUAD]) were investigated as to whether they were sufficiently interchangeable to tailor use to local preference or availability. Methods: A randomized, controlled, open-label, 4-armed, multicenter study in healthy, full-term infants (42-89 days of age) was conducted in 38 centers across the United States. Participants were randomized 1:1:1:1 to a control vaccine group (3 doses DTaP, IPV, and Hib and at Dose 4 DTaP and Hib) and 3 combination vaccine groups: (1) 3 doses PENTA, then Dose 4 DTaP and Hib; (2) 4 QUAD doses and Hib; (3) 4 PENTA doses. Participants (. N=. 2167) were immunized at 2, 4, and 6 months of age, Dose 4 participants (. N=. 1832) at 15 months of age. Immunogenicity was assessed before Doses 1 and 4 and after Doses 3 and 4. Safety was assessed 30 days after each dose and through 180 days Post-Dose 4. Results: Antibody responses and geometric mean concentrations/geometric mean titers (GMCs/GMTs) elicited by each combination vaccine were noninferior (upper-bound 90% confidence interval of GMC/GMT ratios
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U2 - 10.1016/j.vaccine.2012.03.057
DO - 10.1016/j.vaccine.2012.03.057
M3 - Article
C2 - 22475857
AN - SCOPUS:84859838560
VL - 30
SP - 3360
EP - 3368
JO - Vaccine
JF - Vaccine
SN - 0264-410X
IS - 23
ER -