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Inactivated

Immunogenicity Study of the Influenza Vaccine in Adults

Ensayo de Sanofi en Orthomyxoviridae Infections · Influenza (del registro, en inglés).

Más ensayos de: Gripe.

Fase

Fase 2

Estado

Completado

Participantes

978

previstos

Centros

4

Fin del objetivo primario

jun 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2005.

Qué mide

To provide information concerning the immunogenicity of influenza vaccination. (21 Days and 2 Years post-vaccination 1) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroAll marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In addition, the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions. Primary Objective: To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes. Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency (EMEA) after the first injection.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00258934), actualizada en ene 2014.