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Shenzhen trivalent influenza…

Study of a Single Dose or Two Doses of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China

Ensayo de Sanofi en Gripe.

Más ensayos de: Gripe.

Fase

Fase 4

Estado

Completado

Participantes

602

previstos

Centros

1

Fin del objetivo primario

dic 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2014.

Qué mide

Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine (Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe main purpose of this trial is to describe the product profile in terms of immunogenicity and safety following administration of trivalent influenza vaccine (split-virion, inactivated) produced at Shenzhen (SP Shz TIV). Primary objective: * To describe in each group the immune response induced by a single dose (subjects aged ≥ 3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV. Secondary objective: * To describe in each group the safety profile of the vaccine after a single dose (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35 months).

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02228980), actualizada en dic 2015.