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Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
Sponsor: Sanofi Pasteur, a Sanofi Company
Summary
The purpose of the MEQ00073 study is to assess the immunogenicity and safety of a booster dose in children who had been vaccinated with MenACYW conjugate vaccine approximately 5 years earlier as toddlers as part of the MET51 study, and to describe the persistence of a priming dose in children and adolescents who had been vaccinated with MenACYW conjugate vaccine approximately 5 years or 10 years earlier as toddlers as part of the MET51 study, the immunogenicity and safety of a booster dose in adolescents who had been primed with MenACYW conjugate vaccine as toddlers as part of the MET51 study, and the immunogenicity and safety of a second booster dose in adolescents approximately 5 years after a first booster dose as children approximately 5 years after the priming dose as toddlers.
Official title: A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a Booster Dose and Describe the Immune Persistence of MenACYW Conjugate Vaccine With 5- and/or 10-year Booster Doses in Children and Adolescents Who Had Been Primed With MenACYW Conjugate Vaccine as Toddlers.
Key Details
Gender
All
Age Range
6 Years - 7 Years
Study Type
INTERVENTIONAL
Enrollment
209
Start Date
2022-08-23
Completion Date
2027-12-26
Last Updated
2025-07-04
Healthy Volunteers
Yes
Interventions
Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine
Liquid solution for injection Intramuscular
Locations (26)
Investigational Site Number : 2460009
Espoo, Finland
Investigational Site Number : 2460001
Helsinki, Finland
Investigational Site Number : 2460006
Helsinki, Finland
Investigational Site Number : 2460002
Jarvenpaa, Finland
Investigational Site Number : 2460004
Kokkola, Finland
Investigational Site Number : 2460007
Oulu, Finland
Investigational Site Number : 2460003
Pori, Finland
Investigational Site Number : 2460008
Tampere, Finland
Investigational Site Number : 2460010
Turku, Finland
Investigational Site Number : 2760011
Bönnigheim, Germany
Investigational Site Number : 2760001
Bramsche, Germany
Investigational Site Number : 2760007
Bretten, Germany
Investigational Site Number : 2760004
Erfurt, Germany
Investigational Site Number : 2760015
Hamburg, Germany
Investigational Site Number : 2760002
Mönchengladbach, Germany
Investigational Site Number : 2760008
Mönchengladbach, Germany
Investigational Site Number : 2760006
Schönau, Germany
Investigational Site Number : 2760003
Tauberbischofsheim, Germany
Investigational Site Number : 3480002
Budapest, Hungary
Investigational Site Number : 3480001
Budapest, Hungary
Investigational Site Number : 3480005
Miskolc, Hungary
Investigational Site Number : 3480006
Székesfehérvár, Hungary
Investigational Site Number : 7240006
Santiago de Compostela, Galicia [Galicia], Spain
Investigational Site Number : 7240001
Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240002
Madrid, Spain
Investigational Site Number : 7240003
Seville, Spain