• Title/Summary/Keyword: DTPa-IPV

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Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants (한국의 건강한 영아를 대상으로 DTPa-IPV 혼합백신을 접종한 경우와 DTPa 백신과 IPV 백신을 각각 투여하였을 경우의 면역원성, 반응원성 및 안전성)

  • Kim, Chang Hwi;Cha, Sung Ho;Shin, Son Moon;Kim, Chun Soo;Choi, Young Youn;Hong, Young Jin;Chey, Myoung Jae;Kim, Kwang Nam;Hur, Jae Kyun;Jo, Dae Sun;Kim, Sung Shin;Lee, Sang Lak;Song, Eun Song;Ramakrishnan, Gunasekaran;Ok, Jin Ju;Van Der Meeren, Olivier;Bock, Hans L.;Kim, Jung Soo
    • Pediatric Infection and Vaccine
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    • v.17 no.2
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    • pp.156-168
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    • 2010
  • 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-ose 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 ${\geq}99.5%$ 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.