Immunogenicity and safety study of GSK Biologicals’ Infanrix hexa™ when administered in healthy infants at 2, 4 and 6 months of age

Update Il y a 4 ans
Reference: EUCTR2013-004304-19

Woman and Man

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Extract

To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigens [pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN)] one month after the third dose of the primary vaccination.


Inclusion criteria

  • Active immunization against diphtheria, tetanus, pertussis infection caused by all known subtypes of hepatitis B virus, poliomyelitis, and invasive disease caused by Haemophilus influenzae type B (Hib) in infants

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