Calendario›SNY›Meningococcal polysaccharide · MET55
Meningococcal polysaccharide · MET55
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa
Ensayo de Sanofi en Meningococcal Immunization · Healthy Volunteers (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 1.328
- Centros
- 17
- Fin del objetivo primario
- ene 2023
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2019.
Qué mide
Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W (Day 30 (30 days post-vaccination on Day 0)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in RSA.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04143061), actualizada en ene 2025.