Immunogenicity and Safety of a Fully Liquid DTaP5-IPV-Hib Pediatric Combination Vaccine Compared With DTaP3-IPV/Hib Vaccine Administered at 3, 5, and 12 Months of Age: A Randomized, Controlled, Multicenter Study.

University of Tampere Medical School, Vaccine Research Centre, Tampere, Finland.
Clinical and vaccine Immunology: CVI (Impact Factor: 2.47). 08/2013; DOI: 10.1128/CVI.00414-13
Source: PubMed


This study compared the immunogenicity and safety of DTaP5-IPV-Hib and DTaP3-IPV/Hib vaccines at 3, 5, and 12 months of age. Post-Dose 3 noninferiority criteria comparing DTaP5-IPV-Hib to DTaP3-IPV/Hib using seroprotection rates was demonstrated against diphtheria, tetanus, and polio types 1-3, but not for PRP. While PRP did not meet noninferiority criteria, the seroprotection rate and geometric mean concentration (GMC) were high, indicating a clinically robust immune response. GMCs or titres for other antigens (including pertussis) and the safety profile were generally similar between groups. Fully liquid DTaP5-IPV-Hib can be administered using the 3, 5, and 12 month vaccination schedule.

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Available from: Sven Arne Silfverdal, Aug 12, 2014
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    ABSTRACT: Safe and effective combination pediatric vaccines are necessary to simplify complex immunization schedules and to improve coverage and protection for children worldwide. We provide an overview of the 18 years of clinical and worldwide experience with DTaP-IPV-Hib (Pediacel(®)), a unique fully liquid pentavalent vaccine (diphtheria [D], tetanus [T], acellular pertussis, inactivated poliovirus [IPV], Haemophilus influenzae type b [Hib]). Pediacel has demonstrated good and lasting immunogenicity in many populations, with differing primary series and booster schedules, and with a variety of coadministered vaccines. The acellular pertussis antigens have proven efficacy and real-world effectiveness. Clinical and post-marketing studies confirm the safety of Pediacel. Pediacel can be used for primary series and toddler booster doses, as well as in mixed pediatric vaccine schedules.
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