Calendario›SNY›Swine A

Swine A

A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy Europeans Children Aged 6 to 35 Months

Ensayo de Sanofi en Influenza · Swine-origin A/H1N1 Influenza (del registro, en inglés).

Más ensayos de: Gripe.

Fase

Fase 2

Estado

Completado

Participantes

401

previstos

Centros

15

Fin del objetivo primario

ene 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2009.

Qué mide

Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines (21 days post vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives: * To describe the immune response to vaccines 21 days after each vaccination in all participants. * To describe the antibody persistence eight months after the first vaccine administration using hemagglutination inhibition (HAI) method in a subset of participants who received two half-doses of either formulation 1 or 2. * To describe the immune response against the A/H1N1 strain using the HAI method 21 days after last vaccination with the 2010-2011 NH seasonal Trivalent Influenza Vaccine (TIV) administered 13 months after the first vaccination in a subset of subjects who received two half-doses of either t either formulation 1 or 2 of the A/H1N1 influenza vaccines as primary series. * To describe the safety profile of each vaccine in all participants.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00956046), actualizada en ene 2014.