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The Immunogenicity and Safety of a Combined DTaP-IPV//Hib Vaccine Compared with Individual DTaP-IPV and Hib (PRP similar to T) Vaccines: A Randomized Clinical Trial in South Korean Infants

Title
The Immunogenicity and Safety of a Combined DTaP-IPV//Hib Vaccine Compared with Individual DTaP-IPV and Hib (PRP similar to T) Vaccines: A Randomized Clinical Trial in South Korean Infants
Authors
Kang, Jin HanLee, Hoan JongKim, Kyung-HyoOh, Sung HeeCha, Sung-HoLee, JinKim, Nam HeeEun, Byung WookKim, Chang-HwiHong, Young JinKim, Hyun HeeLee, Kyung-YilKim, Yae-JeanCho, Eun YoungKim, Hee SooGuitton, FabriceOrtiz, Esteban
Ewha Authors
김경효
SCOPUS Author ID
김경효scopus
Issue Date
2016
Journal Title
JOURNAL OF KOREAN MEDICAL SCIENCE
ISSN
1011-8934JCR Link1598-6357JCR Link
Citation
vol. 31, no. 9, pp. 1383 - 1391
Keywords
ImmunogenicitySafetyDTaP-IPV VaccineHib VaccineInfantsClinical Trial
Publisher
KOREAN ACAD MEDICAL SCIENCES
Indexed
SCI; SCIE; SCOPUS; KCI WOS scopus
Abstract
Recommended infant vaccination in Korea includes DTaP-IPV and Hib vaccines administered as separate injections. In this randomized, open, controlled study we assessed the non-inferiority of immunogenicity of DTaP-IPV//Hib pentavalent combination vaccine (Pentaxim T) compared with licensed DTaP-IPV and Hib (PRP similar to T) vaccines. We enrolled 418 healthy Korean infants to receive either separate DTaP-IPV and Hib vaccines (n = 206) or the pentavalent DTaP-IPV//Hib (n = 208) vaccine at 2, 4, 6 months of age. Antibodies to all components were measured before the first vaccination and one month after the third, and safety was assessed after each vaccination including recording of reactions by parents. We confirmed the non-inferiority of DTaP-IPV//Hib compared with DTaP-IPV and Hib vaccines; 100% of both groups achieved seroprotection against D, T, IPV, and PRP similar to T, and 97.5%-99.0% demonstrated seroresponses to pertussis antigens. Antibody levels were similar in both groups, except for those to the Hib component, PRP similar to T. In separate and combined groups geometric mean concentrations of anti-PRP similar to T antibodies were 23.9 and 11.0 mu g/mL, respectively, but 98.3% and 97.4% had titers = 1 mu g/mL, indicative of long-term protection. All vaccines were well tolerated, with no vaccine-related serious adverse event. Both groups had similar safety profiles, but the combined vaccine group had fewer injection site reactions. The immunological non-inferiority and similar safety profile of DTaP-IPV//Hib vaccine to separate DTaP-IPV and Hib vaccines, with the advantage of fewer injections and injection site reactions, supports the licensure and incorporation of DTaPIPV//Hib into the Korean national vaccination schedule.
DOI
10.3346/jkms.2016.31.9.1383
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의학전문대학원 > 의학과 > Journal papers
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