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Research Paper

Immunogenicity and Reactogenicity of Two Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-Inactivated Polio Virus-Haemophilus influenzae Type b Vaccines Administered at 3, 5 and 11–12 Months of Age

Terhi M. Kilpi, Sven Arne Silfverdal, Lennart Nilsson, Ritva Syrjänen, Cesare Belloni, Maria Desole, Chiara Triban, Jann Storsaeter, Maaria Soila and Jeanne-Marie Jacquet

volume 5 | issue 1

January 2009

This is an open-access article

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The use of combination vaccines in the routine childhood program reduces distress to the recipients and is likely to improve uptake rates and timeliness of vaccination but requires careful evaluation and surveillance. The aim of this study was to evaluate the immunogenicity and reactogenicity of two commercial diphtheria-tetanus- acellular pertussis-hepatitis b-inactivated polio virus-Haemophilus influenzae type b (DTaP-HBV-IPV/Hib) combination vaccines when administered to infants at 3, 5 and 11-12 months of age A total of 494 infants were randomized to receive three doses of either Infanrix hexa™ (GlaxoSmithKline Biologicals; N=246) or Hexavac™ (Sanofi Pasteur MSD; N=248) in 10 centers in Italy, Finland and Sweden. After the third dose, antibodies to diphtheria, tetanus, polio and Hib were at the protective level in nearly all infants in both groups whereas the proportion of subjects who had achieved the protective concentration of ≥10 mIU/ml to hepatitis B surface antigen was 99.1% (95% CI 96.7-99.9) in the Infanrix hexa™ group as compared to 94.4% (95% CI 90.4-97.1) in the Hexavac™ group. Antibody titers to all three polio antigens were highest in Italy and lowest in Finland. Clinically relevant general reactions (such as fever of >39.5 °C) were mostly reported in less than 5% of the vaccinees. Three doses of DTaP-HBV-IPV/Hib combination vaccines produced sufficient immune responses in nearly all vaccinees.

Authors

Terhi M. Kilpi

Department of Vaccines; National Public Health Institute (KTL); Helsinki, Finland

Sven Arne Silfverdal

Department of Pediatrics; Örebro University Hospital; Örebro, Sweden

Lennart Nilsson

Department of Pediatrics/Allergy Centre; University Hospital; Linköping, Sweden

Ritva Syrjänen

Department of Vaccines; National Public Health Institute (KTL); Helsinki, Finland

Cesare Belloni

Division of Neonatology-Neonatal Pathology-Intensive Care; I.R.C.C.S. San Matteo Hospital; Pavia, Italy

Maria Desole

Public Health Service; AUSL 1; Sassari, Italy

Chiara Triban

GlaxoSmithKline Biologicals; Verona, Italy; Solna, Sweden; Espoo, Finland; Rixensart, Belgium

Jann Storsaeter

GlaxoSmithKline Biologicals; Verona, Italy; Solna, Sweden; Espoo, Finland; Rixensart, Belgium

Maaria Soila

GlaxoSmithKline Biologicals; Verona, Italy; Solna, Sweden; Espoo, Finland; Rixensart, Belgium

Jeanne-Marie Jacquet

GlaxoSmithKline Biologicals; Verona, Italy; Solna, Sweden; Espoo, Finland; Rixensart, Belgium


This is an open-access article

 Download PDF

If the document does not open, please right-click on the link (control-click on a Macintosh) and select the option to save the file to disk.