Journal List > Korean J Pediatr Infect Dis > v.17(2) > 1096106

TOOLS
Kim, Cha, Shin, Kim, Choi, Hong, Chey, Kim, Hur, Jo, Kim, Lee, Song, Ramakrishnan, Ok, Van Der Meeren, Bock, and Kim: Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants
Original Article
Korean Journal of Pediatric Infectious Diseases

Korean Journal of Pediatric Infectious Diseases 2010; 17(2): 156-168.

Published online: 31 December 2010

DOI: https://doi.org/10.14776/kjpid.2010.17.2.156

Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants

Chang Hwi Kim, M.D., Sung Ho Cha, M.D.*, Son Moon Shin, M.D.†, Chun Soo Kim, M.D.‡, Young Youn Choi, M.D.∫, Young Jin Hong, M.D.∥, Myoung Jae Chey, M.D., Kwang Nam Kim, M.D.**, Jae Kyun Hur, M.D.††, Dae Sun Jo, M.D.††, Sung Shin Kim, M.D., Sang Lak Lee, M.D.‡, Eun Song Song, M.D.∫, Gunasekaran Ramakrishnan∫∫, Jin Ju Ok, M.D.∫∫, Olivier Van Der Meeren∫∫, Hans L Bock∫∫, Jung Soo Kim, M.D.‡‡

Department of Pediatrics, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.

*Department of Pediatrics, Kyunghee University Hospital, Seoul, Korea.

†Department of Pediatrics, Cheil General Hospital and Women's Healthcare Center, Kwandong University College of Medicine, Seoul, Korea.

‡Department of Pediatrics, Keimyung Dongsan Medical Center, Keimyung University, Daegu, Korea.

∫Department of Pediatrics, Chonnam National University Hospital, Gwangju, Korea.

∥Department of Pediatrics, Inha University Hospital, Incheon, Korea.

Department of Pediatrics, Sanggye Paik Hospital, Seoul, Korea.

**Department of Pediatrics, Hangang Sacred Heart Hospital, Seoul, Korea.

††Department of Pediatrics, St. Paul's Hospital, Seoul, Korea.

‡‡Department of Pediatrics, Chonbuk National University Hospital, Jeonju, Korea.

∫∫GlaxoSmithKline Biologicals, Wavre, Belgium.

Correspondence: Jung Soo Kim, M.D. Department of Pediatrics, Chonbuk National University Hospital, Jeonbuk, Korea. Tel: +82-63-250-1468, Fax: +82-63-250-1464, (kimjsp@chonbuk.ac.kr)

Received 10 June 2010       Revised 1 November 2010       Accepted 3 November 2010

Copyright © 2010 The Korean Society of Pediatric Infectious Diseases

Abstract

Purpose

To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, Infanrix™ IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV).

Methods

A total of 458 infants aged 8-12 weeks were randomized to receive three-dose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards.

Results

One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 were ≥99.5% and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully.

Conclusion

Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization.

Keywords: Acellular pertussis, DTPa-IPV, DTPa, IPV, Primary vaccination

TOOLS
Similar articles