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Meningococcal Polysaccharide…

Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers

Ensayo de Sanofi en Meningococcal Meningitis · Measles · Mumps · Rubella · Varicella (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

1.664

previstos

Centros

88

Fin del objetivo primario

ene 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, simple ciego. Comenzó en dic 2006.

Qué mide

Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) (Day 30 after the 12-month vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers. Primary Objectives: * To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine. * To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine. Observational Objectives: Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination\[s\]) in subjects in the study groups. Immunogenicity: \- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00422292), actualizada en abr 2016.