A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of Fluad® or Agrippal® in Previously Unvaccinated Healthy Subjects Aged 6 to <36 Months

Femme et Homme

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Extrait

To explore the cell mediated immune (CMI) responses to two 0.25 mL IM injections of Fluad or to two 0.25 mL IM injections of Agrippal as determined by the quality and quantity of the antigen-specific T- cells responses after in-vitro restimulation of peripheral blood mononuclear cells in previously unvaccinated healthy children aged 6 to <36 months. To evaluate the safety and tolerability of two 0.25 mL IM injections of Fluad or Agrippal in previously unvaccinated healthy children aged 6 to <36 months.

Critère d'inclusion

Influenza

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A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of Fluad® or Agrippal® in Previously Unvacci...