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Injectable inactivated types 1

Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine

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

Más ensayos de: Poliomielitis.

Fase

Fase 4

Estado

Completado

Participantes

456

previstos

Centros

1

Fin del objetivo primario

may 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en nov 2011.

Qué mide

Neutralizing antibody titers ≥8 (1/dil) against each of the 3 poliovirus serotypes (types 1, 2 and 3) after the 3 dose primary vaccination series. (1 month post-dose 3 (primary vaccination series)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is to generate data to support the registration extension of IMOVAX Polio to be used in a sequential vaccination. Primary objective: * To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2) poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of seroprotection rate 28 to 42 days after the third dose of the primary vaccination series. Secondary objectives: * To evaluate the safety profile of the investigational vaccines after each administration in each group. * To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3) before the first dose and 28 to 42 days after the third primary series dose of vaccine in each group. * To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and 3) after the third primary series dose administration, at 18 months of age in each group.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01475539), actualizada en ene 2015.