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Influenza VLP Vaccine
Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults
Ensayo de NOVAVAX INC en Gripe.
Más ensayos de: Gripe.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 317
- Centros
- 4
- Fin del objetivo primario
- mar 2009
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en sep 2008.
Qué mide
To assess the tolerability and safety of Influenza VLP Vaccine (del registro, en inglés) (6 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroA Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in Healthy Adults. Study Objectives: Primary: * To assess the tolerability and safety of Influenza VLP Vaccine * To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the three component viral strains Secondary: * To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers against drifted strains * To quantify antibody against neuraminidase and hemagglutinin following administration of Influenza VLP Vaccine * To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine as quantified by interferon-gamma (IFNg) and Granzyme-B produced by peripheral blood mononuclear cells (PBMCs).
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Todos los de NVAX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00754455), actualizada en jul 2013.