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Immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine’s new formulation as com-pared with DTPa-HBV-IPV/Hib vaccine’s current formulation when administered in...

Mise à jour : Il y a 5 ans
Référence : EUCTR2012-002427-15

Immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine’s new formulation as com-pared with DTPa-HBV-IPV/Hib vaccine’s current formulation when administered in healthy infants at 3, 4 and 5 months of age

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Extrait

To demonstrate that the immunogenicity of the DTPa-HBV-IPV/Hib vaccine (new formulation) in terms of response to all vaccine antigens is non-inferior to that of the DTPa-HBV-IPV/Hib vaccine (current formulation), one month after a three-dose primary vaccination course.

Critère d'inclusion

  • Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis diseases and, if applicable, Haemophilus influenzae type b disease

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