Immunogenicity, safety and reactogenicity of GSK Biologicals’ Hib-MenCY-TT vaccine 792014 compared to Merck & Co, Inc. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) vaccine in heal...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-003459-39

Immunogenicity, safety and reactogenicity of GSK Biologicals’ Hib-MenCY-TT vaccine 792014 compared to Merck & Co, Inc. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) vaccine in healthy infants and toddlers

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Extrait

•To demonstrate non-inferiority of 4 doses of Hib-MenCY-TT compared to 3 doses of PedvaxHIB,when co-administered with Prevnar 13 and Havrix,in terms of anti-PRP concentration Epoch 001:To demonstrate non-inferiority of •2 doses of Rotarix co-administered with Hib-MenCY-TT,Pediarix and Prevnar 13 compared to Rotarix co-administered with PedvaxHIB,Pediarix and Prevnar 13 in terms of Rotarix IgA GMCs •3 doses of Prevnar 13 co-administered with Hib-MenCY-TT,Rotarix and Pediarix compared to Prevnar 13 co-administered with PedvaxHIB,Rotarix and Pediarix in terms of S. pneumoniae GMCs Epoch 002:To demonstrate non-inferiority of •2 doses of Havrix when the 1st dose is co-administered with Hib-MenCY-TT and Prevnar 13 compared to Havrix when the 1st dose is co-administered with PedvaxHIB and Prevnar 13,at 12-15 months of age •4 doses of Prevnar 13 co-administered with Hib-MenCY-TT and Havrix compared to Prevnar 13 co-administered with PedvaxHIB and Havrix in terms of S. pneumoniae GMCs


Critère d'inclusion

  • invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroups C (MenC) and Y (MenY)