Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of a Fully Liquid Combination Diphtheria–Tetanus Toxoid–Five-Component Acellular Pertussis (DTaP5), Inactivated Poliovirus (IPV), and Haemophilus influenzae Type b (Hib) Vaccine Compared with a DTaP3-IPV/Hib Vaccine Administered at 3, 5, and 12 Months of Age | Zendy

Timo Vesikari | Zendy; SvenArne Silfverdal | Zendy; Florence Boisnard | Zendy; Stéphane Thomas | Zendy; Grace Mwawasi | Zendy; Donna L. Reynolds | Zendy

Open Access

Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of a Fully Liquid Combination Diphtheria–Tetanus Toxoid–Five-Component Acellular Pertussis (DTaP₅), Inactivated Poliovirus (IPV), and Haemophilus influenzae Type b (Hib) Vaccine Compared with a DTaP₃-IPV/Hib Vaccine Administered at 3, 5, and 12 Months of Age

Author(s) -

Timo Vesikari,

SvenArne Silfverdal,

Florence Boisnard,

Stéphane Thomas,

Grace Mwawasi,

Donna L. Reynolds

Publication year - 2013

Publication title -

clinical and vaccine immunology

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.649

H-Index - 77

eISSN - 1556-6811

pISSN - 1556-679X

DOI - 10.1128/cvi.00414-13

Subject(s) - diphtheria , tetanus , immunogenicity , toxoid , poliovirus , inactivated poliovirus vaccine , medicine , diphtheria toxin , virology , corynebacterium diphtheriae , pertactin , microbiology and biotechnology , vaccination , immunology , antibody , toxin , pertussis toxin , biology , virus , receptor , g protein

This study compared the levels of immunogenicity and safety of diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP(5)), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP(5)-IPV-Hib) and DTaP(3)-IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP(5)-IPV-Hib to DTaP(3)-IPV/Hib using rates of seroprotection were demonstrated against diphtheria, tetanus, and polio types 1 to 3, but not for polyribosylribitol phosphate (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 titers for other antigens (including pertussis) and the safety profiles were generally similar between groups. Fully liquid DTaP(5)-IPV-Hib can be administered using the 3-, 5-, and 12-month vaccination schedule. (This study has been registered at ClinicalTrials.gov under registration no. NCT00287092.).

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