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

NCT ID: NCT04936685

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2027-12-26

Brief 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.

Detailed Description

The duration of each participant's participation will be approximately 5.5 years

Conditions

Meningococcal Immunisation; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

Participants will receive a first booster dose of MenACYW conjugate vaccine at Day 1 and a second booster dose at year 5 of study MEQ00073

Group Type: EXPERIMENTAL

Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine

Intervention Type: BIOLOGICAL

Liquid solution for injection Intramuscular

Group 2

Participants will receive a single booster dose of MenACYW conjugate vaccine at year 5 of study MEQ00073

Group Type: EXPERIMENTAL

Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine

Intervention Type: BIOLOGICAL

Liquid solution for injection Intramuscular

Interventions

Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine

Liquid solution for injection Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

MenACYW conjugate vaccine MenQuadfi®

Eligibility Criteria

Inclusion Criteria

• Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2)
• Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures
• Covered by health insurance, if required by local regulations

Exclusion Criteria

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
• At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease)
• Personal history of Guillain-Barré syndrome (GBS)
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
• Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 (Group 1 and 3) and of Meningococcal B vaccine
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number : 2460009

Espoo, , Finland

Investigational Site Number : 2460001

Helsinki, , Finland

Investigational Site Number : 2460006

Helsinki, , Finland

Investigational Site Number : 2460002

Järvenpää, , 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

Countries

Finland; Germany; Hungary; Spain

References

Martinon-Torres F, Simko R, Ebert R, Ramet M, Zocchetti C, Syrkina O, Bchir S, Bertrand-Gerentes I. Five-Year Immune Persistence of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) and Immunogenicity and Safety of a Booster Dose in Children. Infect Dis Ther. 2025 May;14(5):991-1010. doi: 10.1007/s40121-025-01121-6. Epub 2025 Apr 1.

Reference Type: DERIVED

PMID: 40169489 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1255-4941

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-000104-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MEQ00073

Identifier Type: -

Identifier Source: org_study_id