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Licensed 2010-2011 Trivalent…
Study of Quadrivalent Influenza Vaccine Among Children
Ensayo de Sanofi en Gripe.
Más ensayos de: Gripe.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 4.363
- Centros
- 67
- Fin del objetivo primario
- dic 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en nov 2010.
Qué mide
Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants (Day 28 post final vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1), and the investigational TIV containing the alternate B (B2) strain in children. Primary Objective: To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among children aged 6 months to less than 9 years of age Secondary Objective: To demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates. Observational Objective: To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01240746), actualizada en jun 2015.