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MenACYW conjugate vaccine
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
Ensayo de Sanofi en Meningococcal Immunisation · Healthy Volunteers (del registro, en inglés).
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 71
- Centros
- 2
- Fin del objetivo primario
- sep 2024
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en sep 2023.
Qué mide
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W (Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study evaluated the immunogenicity and safety of a single dose of MenQuadfi® administered as a booster vaccine in toddlers 12 - 23 months of age in Argentina who had been primed with at least 1 dose of the quadrivalent meningococcal conjugate vaccines Nimenrix® or Menveo® during infancy to protect against invasive meningococcal disease (IMD). Participants received a single dose of MenQuadfi® at Visit 1. Participants provided 2 blood samples, one at D01 (Visit 1) pre-vaccination and another at D31 (Visit 2) post-vaccination for the immunogenicity assessments. Study included 2 visits at D01 (Visit 1) and at D31 (Visit 2), and 1 Telephone call (TC) for safety follow-up at D09 post-study vaccination.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05929651), actualizada en ago 2025.