Evaluation of the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Quadrivalent Influenza Vaccine Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) when co-administered with Pneumovax™ 2...

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-001118-24

Evaluation of the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Quadrivalent Influenza Vaccine Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) when co-administered with Pneumovax™ 23 in adults 50 years of age and older

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Extrait

1) To demonstrate the non-inferiority of the immune response to D-QIV (FLU D-QIV) in terms of HI antibody titres at Day 28 after D-QIV vaccination, for each influenza virus strain, when co-administered with or administered separately from PPV23 (Pneumovax 23). 2) To demonstrate the non-inferiority of the humoral immune response to PPV23 in terms of anti-pneumococcal antibody concentrations at 28 days after administration of the pneumococcal vaccine, for six pneumococcal serotypes (1, 3, 4, 7F, 14, 19A) , when co administered with or administered separately from D-QIV.


Critère d'inclusion

  • The target population for this study is adults in stable health ≥ 50 years of age at risk for complications of influenza and pneumococcal diseases