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Flu-ID 15μg
Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine
Ensayo de Sanofi en Gripe.
Más ensayos de: Gripe.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 795
- Centros
- 8
- Fin del objetivo primario
- dic 2007
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2007.
Qué mide
Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination. (del registro, en inglés) (21 dias)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary objective: \* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres Secondary objectives * Immunogenicity * To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route.. * To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects * Safety \- To describe the safety profile after vaccination in each group * Acceptability * To describe the pain at the injection site * To describe the comfort of the injection
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00554333), actualizada en mar 2018.