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J Korean Med Sci. 2016 Sep;31(9):1383-91. doi: 10.3346/jkms.2016.31.9.1383.

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

Author information

1
Department of Pediatrics, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
2
Department of Pediatrics, Seoul National University Children's Hospital, Seoul National University College of Medicine, Seoul, Korea. hoanlee@snu.ac.kr.
3
Department of Pediatrics, Ewha Womans University Mokdong Hospital, Seoul, Korea.
4
Department of Pediatrics, Hanyang University Medical Center, Seoul, Korea.
5
Department of Pediatrics, Kyung Hee University Hospital, Seoul, Korea.
6
Department of Pediatrics, KEPCO Medical Center, Seoul, Korea.
7
Department of Pediatrics, Inje University Ilsan Paik Hospital, Ilsan, Korea.
8
Department of Pediatrics, Eulji University School of Medicine, Eulji General Hospital, Seoul, Korea.
9
Department of Pediatrics, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
10
Department of Pediatrics, Inha University Hospital, Incheon, Korea.
11
Department of Pediatrics, The Catholic University of Korea, Uijeongbu St. Mary's Hospital, Uijeongbu, Korea.
12
Department of Pediatrics, The Catholic University of Korea, Daejeon St. Mary's Hospital, Daejeon, Korea.
13
Department of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea.
14
Department of Pediatrics, Seoul National University Children's Hospital, Seoul National University College of Medicine, Seoul, Korea.
15
Sanofi Pasteur, Seoul, Korea.
16
Sanofi Pasteur, Lyon, France.

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™) compared with licensed DTaP-IPV and Hib (PRP~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~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~T. In separate and combined groups geometric mean concentrations of anti-PRP~T antibodies were 23.9 and 11.0 μg/mL, respectively, but 98.3% and 97.4% had titers ≥ 1 μg/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 DTaP-IPV//Hib into the Korean national vaccination schedule (Clinical trial registry, NCT01214889).

KEYWORDS:

Clinical Trial; DTaP-IPV Vaccine; Hib Vaccine; Immunogenicity; Infants; Safety

PMID:
27510380
PMCID:
PMC4974178
DOI:
10.3346/jkms.2016.31.9.1383
[Indexed for MEDLINE]
Free PMC Article

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