Calendario›SNY›T dap + Meningococcal…

T dap + Meningococcal…

Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

Ensayo de Sanofi en Meningitis · Meningococcemia · Pertussis · Tetanus · Diphtheria (del registro, en inglés).

Fase

Fase 4

Estado

Completado

Participantes

1.345

previstos

Centros

20

Fin del objetivo primario

mar 2007

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en abr 2005.

Qué mide

Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. (Day 0 to Day 28 post-vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Primary Objective: To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately. Secondary Objective: To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00777257), actualizada en ene 2014.