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A phase II, open, study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine when administered as a booster dose to children aged 16-...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-005343-16

A phase II, open, study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine when administered as a booster dose to children aged 16-20 months, previously primed with GSK Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine, containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD] or with GSK Biologicals licensed DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) in the primary vaccination study DTPa-HBV-IPV-116 (106786)

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Extrait

To assess the immunogenicty of the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of persistence of the antibodies to all vaccine antigens at the time of the booster vaccination. To assess the immunogenicity of a booster dose of DTPa-HBV-IPV/Hib vaccine given after primary vaccination with the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of response to all vaccine antigens.

Critère d'inclusion

  • Booster immunisation of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b

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