A phase II, observer-blind, multicountry, multicentre, randomized study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals’ influenza vaccine adjuvanted with ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-003802-86

A phase II, observer-blind, multicountry, multicentre, randomized study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals’ influenza vaccine adjuvanted with various doses of the oil in water emulsion and MPL, administered in adults aged 65 years and older, and compared to Fluarix™

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Extrait

To identify an optimal formulation (combination of one o/w emulsion dosage and one MPL dosage) of the adjuvanted influenza vaccine compared to Fluarix, given intramuscularly in subjects aged 65 years old and above, based on immunogenicity (GMT) for the three vaccine strains 21 days following vaccination.


Critère d'inclusion

  • Immunization against influenza in male and female subjects aged 18-40 years old and 65 years and above