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Quadrivalent influenza vaccine
Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years
Ensayo de Sanofi en Gripe.
Más ensayos de: Gripe.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 300
- Centros
- 5
- Fin del objetivo primario
- abr 2016
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en sep 2015.
Qué mide
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route (Day 0 (pre-vaccination) and Day 21 post-vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety. Objectives: * To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH 2015-2016 formulation, with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed. * To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02550197), actualizada en mar 2022.