Safety and immunogenicity of new formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) in primary infant vaccination

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-021569-58

Femme et Homme

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Extrait

To demonstrate that the immunogenicity of at least one DTPa-HBVIPV/ Hib formulation is non-inferior to the licensed formulation in terms of seroprotection rates to diphtheria, tetanus, hepatitis B and PRP antigens and in terms of antibody geometric mean concentrations (GMCs) for pertussis antigens one month after the third dose of the primary vaccination.


Critère d'inclusion

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

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