Immunogenicity and safety study of GlaxoSmithKline Biologicals' Havrix administered on a 0, 6-month schedule concomitantly with GlaxoSmithKline Biologicals' Infanrix and Aventis Pasteur's Ac-tHIB in healthy children 15 months of age

Femme et Homme

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Extrait

To demonstrate non-inferiority of the anti-HAV immune response (with respect to both seropositivity rates and GMCs) 31 days following the second dose of Havrix when the first dose of Havrix is co-administered with Infanrix and ActHIB (HAV+DTaP+HIB Group) compared to Havrix given alone (HAV Group). To demonstrate the non-inferiority of the anti-diphtheria (D) and anti-tetanus (T) seroprotection rates; anti-pertussis (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) GMCs and vaccine response rates; and anti-polyribosylribitol phosphate (PRP) seroprotection rate 31 days following the co-administration of Infanrix and ActHIB with the first dose of Havrix (HAV+DTaP+HIB Group) compared to Infanrix and ActHIB given alone (DTaP+HIB→HAV Group).

Critère d'inclusion

Active immunization against hepatitis A, , diphtheria, tetanus, pertussis and Haemophilus influenza type B infections of healthy children 15 months of age at the time of the first study vaccination

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Immunogenicity and safety study of GlaxoSmithKline Biologicals' Havrix administered on a 0, 6-month schedule concomitantly with GlaxoSmithKline Biologicals' Infanrix and Aventis Pasteur's Ac-tHIB in h...