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A Phase II, Observer-Blind, Parallel Groups, Single-Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of FLUAD or Vaxigrip Influenza Vaccines in H...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-003339-22

A Phase II, Observer-Blind, Parallel Groups, Single-Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of FLUAD or Vaxigrip Influenza Vaccines in Healthy Children who Received Either One or the Other Vaccine in the Previous V70P2 Study

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Extrait

·To evaluate the immunogenicity of a single 0.25mL intramuscular (IM) injection of FLUAD or Vaxigrip influenza vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by HI test in healthy children aged up to 35 months. ·To evaluate the immunogenicity of a single 0.5mL intramuscular (IM) injection of FLUAD or Vaxigrip influenza vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by HI test in healthy children aged up to 48 months. ·To overall evaluate the immunogenicity of a single 0.25mL or 0.5mL intramuscular (IM) injection of FLUAD or Vaxigrip influenza vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by HI test in healthy children aged up to 48 months.

Critère d'inclusion

  • Influenza

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