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Meningococcal Polysaccharide

Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age

Ensayo de Sanofi en Meningococcal Immunisation (Healthy Volunteers) (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

360

previstos

Centros

4

Fin del objetivo primario

nov 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2020.

Qué mide

Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis (Day 30 (post-vaccination)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine). Secondary Objective: Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or Menactra®. Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04368429), actualizada en sep 2025.