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Inactive Poliovirus Vaccine

Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan

Ensayo de Sanofi en Poliomyelitis · Polio (del registro, en inglés).

Más ensayos de: Poliomielitis.

Fase

Fase 3

Estado

Completado

Participantes

74

previstos

Centros

2

Fin del objetivo primario

ene 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jul 2011.

Qué mide

A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination (1 month post-vaccination 3) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose primary and booster vaccination in Japanese infants aged 3 through 68 months. Primary objective: * To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV). Secondary objective: * To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine response rates and Geometric Mean Titers) of IPV before and after the primary vaccination and before and after the booster vaccination. * To describe the safety after each dose of IPV.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01389687), actualizada en mar 2013.