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MenACYW conjugate vaccine
Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children
Ensayo de Sanofi en Meningococcal Infections (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 91
- Centros
- 8
- Fin del objetivo primario
- sep 2018
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2018.
Qué mide
Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 (Day 0 (pre-vaccination)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis was an open-label, multi-center study to describe the immune persistence of the priming dose and describe the immunogenicity and safety of a booster dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine in children in Finland who had been vaccinated 3 years earlier as toddlers with either MenACYW conjugate vaccine or Nimenrix® as part of the MET54 study (NCT03205358). The objectives were: * To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. * To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. * To describe the antibody responses against tetanus toxoid 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. * To describe the safety profile of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03476135), actualizada en mar 2022.