Korean J Pediatr Infect Dis.  2010 Dec;17(2):156-168.

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

Affiliations
  • 1Department of Pediatrics, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
  • 2Department of Pediatrics, Kyunghee University Hospital, Seoul, Korea.
  • 3Department of Pediatrics, Cheil General Hospital and Women's Healthcare Center, Kwandong University College of Medicine, Seoul, Korea.
  • 4Department of Pediatrics, Keimyung Dongsan Medical Center, Keimyung University, Daegu, Korea.
  • 5Department of Pediatrics, Chonnam National University Hospital, Gwangju, Korea.
  • 6Department of Pediatrics, Inha University Hospital, Incheon, Korea.
  • 7Department of Pediatrics, Sanggye Paik Hospital, Seoul, Korea.
  • 8Department of Pediatrics, Hangang Sacred Heart Hospital, Seoul, Korea.
  • 9Department of Pediatrics, St. Paul's Hospital, Seoul, Korea.
  • 10Department of Pediatrics, Chonbuk National University Hospital, Jeonju, Korea. kimjsp@chonbuk.ac.kr
  • 11GlaxoSmithKline Biologicals, Wavre, Belgium.

Abstract

PURPOSE
To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, Infanrix(TM) 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 > or =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.

Keyword

Acellular pertussis; DTPa-IPV; DTPa; IPV; Primary vaccination

MeSH Terms

Aged
Appointments and Schedules
Humans
Immunization
Incidence
Infant
Pentetic Acid
Poliovirus
Vaccination
Vaccines
Whooping Cough
Pentetic Acid
Vaccines
Full Text Links
  • KJPID
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr