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Influenza Virus Vaccine USP…
Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years
Ensayo de Sanofi en Gripe.
Más ensayos de: Gripe.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 3.360
- Centros
- 38
- Fin del objetivo primario
- jun 2013
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2012.
Qué mide
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route (Day 28 post-vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2) vaccines in producing protection against four strains of influenza virus. Primary Objective: * To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28 days post-vaccination. Secondary Objectives: * To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by HAI GMTs and seroconversion rates) that is superior to the response induced by the TIV-ID that does not contain the corresponding B strain. * To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID. * To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64 years), race, ethnicity, gender, previous vaccination status, and baseline seropositivity status. * To describe the safety profile for subjects who receive QIV-ID and TIV-ID. Observational Objectives: * To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or Grade 3 solicited systemic reactions combined * To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3 solicited injection site reactions combined.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01712984), actualizada en abr 2015.