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ACTIVE NOT RECRUITING
NCT04936685
PHASE3

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

View on ClinicalTrials.gov

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

BIOLOGICAL

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