An open-label, randomized, multi-center study of the immunogenicity and safety of DTaP-IPV (Kinrix? co-administered with MMR vaccine with or without varicella vaccine in healthy pre-school age children

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• 作者：Nicola P. Klein^a ; ^{nicola.klein@kp.org} ; Wayde M. Weston^b ; ^{Wayde.Weston@gsk.com} ; Sherine Kuriyakose^c ; ^{Sherine.o.kuriyakose@gsk.com} ; Devayani Kolhe^c ; ^{Devayani.a.kolhe@gsk.com} ; Barbara Howe^b ; ^{Barbara.J.Howe@gsk.com} ; Leonard R. Friedland^b ; ^{Leonard.R.Friedland@gsk.com} ; Olivier Van Der Meeren^d ; ^{Olivier.X.Van-Der-Meeren@gskbio.com}
• 关键词：ATP ; according-to-protocol ; CI ; confidence interval ; DTaP&ndash ; IPV ; combined diphtheria&ndash ; tetanus&ndash ; acellular pertussis and inactivated poliovirus vaccine ; GSK ; GlaxoSmithKline Biologicals ; GMC/GMT ; geometric mean antibody concentration/titer ; MM
• 刊名：Vaccine
• 出版年：2012
• 出版时间：11 January 2012
• 年：2012
• 卷：30
• 期：3
• 页码：668-674
• 全文大小：337 K

文摘

Background

In the US, it is recommended that 4-6 year old children receive diphtheria-tetanus-acellular pertussis (DTaP), inactivated poliovirus (IPV), measles-mumps-rubella (MMR), varicella (V), and influenza vaccines. Data relating to the concomitant administration of combination DTaP-IPV vaccine (Kinrix? GlaxoSmithKline Biologicals) and influenza or V vaccines are currently limited. This study was undertaken to evaluate the immunogenicity and reactogenicity of Kinrix?when co-administered with MMR (M-M-RII^?, Merck & Co.) and Varivax?(Merck & Co.) in 4-6 year old children.

Methods

Phase IIIb, open-label, non-inferiority study (). We randomized (1:1) healthy 4-6 year olds to receive Kinrix?#xA0;+ MMR + V on day 0 (Group 1), or Kinrix?#xA0;+ MMR on day 0, followed by V at month 1 (Group 2). We measured DTaP-IPV immunogenicity before and 1 month post-vaccination (prior to V vaccination in Group 2). We collected local and general solicited symptoms within 4 days after vaccination and serious adverse events (SAEs) through 6 months post-vaccination.

Results

We enrolled 478 subjects. One month post-vaccination, >95 % of subjects in both groups had booster responses to diphtheria, tetanus and pertussis antigens and all subjects had seroprotective anti-poliovirus antibody titers. Immune responses in Group 1 were non-inferior to Group 2 for responses to DTaP-IPV antigens according to pre-specified criteria. Reporting of solicited local events at the DTaP-IPV site appeared to be similar between the two vaccine groups, as was reporting of solicited general adverse events within 4 days of vaccination; no vaccine related SAEs were reported.

Conclusion

Concomitant administration of varicella vaccine with Kinrix?and MMR did not impact the immunogenicity of diphtheria, tetanus, pertussis or poliovirus antigens. Both vaccine regimens were well tolerated. These results support the co-administration of DTaP-IPV, MMR, and V vaccines in 4-6-year-old children, providing protection against multiple diseases in a timely and efficient manner.