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Typhoid Vi polysaccharide

Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects

Ensayo de Sanofi en Salmonella Infections · Typhoid Fever · Bacterial Infections (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

200

previstos

Centros

3

Fin del objetivo primario

sep 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2012.

Qué mide

Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine (Day 0 (pre-vaccination) to Day 28 (post-vaccination)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is designed to assess the immunogenicity and safety of typhoid Vi polysaccharide vaccine in Japanese participants to support registration of the product in Japan. Primary Objective: To describe the seroconversion rate (percentage of subjects with at least a 4-fold increase of their Vi antibody titer) between Day 0 before vaccination and Day 28 after vaccination with typhoid Vi polysaccharide (SP093) vaccine in subjects aged 2 years and above. Secondary Objectives: * To describe the safety profile of a single dose of typhoid Vi polysaccharide vaccine up to 28 days after vaccination, in subjects aged 2 years and above. * To describe the immune response following a single dose of typhoid Vi polysaccharide vaccine in subjects aged 2 years and above.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01608815), actualizada en abr 2014.