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Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children
This 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.
Details
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 91 |
| Start date | Tue Feb 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Sep 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Meningococcal Infections
Interventions
- MenACYW conjugate vaccine
Countries
Finland