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A Phase III, randomized, observer-blind, controlled, multi-center clinical study to evaluate the efficacy, safety and immunogenicity of one and two intramuscular doses of FLUAD versus control vaccines...

Mise à jour : Il y a 5 ans
Référence : EUCTR2007-003786-41

A Phase III, randomized, observer-blind, controlled, multi-center clinical study to evaluate the efficacy, safety and immunogenicity of one and two intramuscular doses of FLUAD versus control vaccines in unprimed healthy subjects aged between 6 and up to 72 months

Femme et Homme

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Extrait

Safety: To demonstrate the safety and tolerability of one or two 0.25mL IM doses of FLUAD in unprimed children aged 6 to <36 months, compared with Agrippal S1 and/or with Influsplit SSW (flu vaccine control) in terms of any solicited local and systemic reactions (combined) reported within 7 days after any vaccination. Absolute efficacy: To demonstrate protection provided by two 0.25mL intramuscular (IM) doses of FLUAD in unprimed children aged 6 to <36 months, compared with Menjugate/Encepur Children (non-flu vaccine control), against influenza illness caused by virus-confirmed community-acquired influenza wild type strains matching with those contained in the vaccine

Critère d'inclusion

  • no medical, condition: unprimed, healthy,

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