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

NCT04936685 | Active Not Recruiting Phase 3 Results FDA Drug

• 3 other identifiers: MEQ00073U1111-1255-49412021-000104-38
• Study Type: interventional
• Target: 209
• Locations: 4 countries
• Sites: 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.

Conditions

Meningococcal Immunisation; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose

  Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: percentage of participants with a pre-vaccination titer \< 1:8, who had achieved a post-vaccination titer \>= 1:16 or participants with a pre-vaccination titer \>= 1:8, who had achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer. The seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% confidence interval (CI) is \> 75%.

  Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose

Secondary Outcomes (19)

• Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination

  At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51)

• Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y

  Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose

• Group 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y

  From Baseline (Day 1) until end of the study (approximately 5.5 years)

• Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8

  Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose

• Group 2: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8

  From Baseline (Day 1) until end of the study (approximately 5.5 years)

Study Arms (2)

Group 1

EXPERIMENTAL

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

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

Group 2

EXPERIMENTAL

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

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

Interventions

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

Liquid solution for injection Intramuscular

Also known as: MenACYW conjugate vaccine MenQuadfi®

Group 1; Group 2

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (26)

Investigational Site Number : 2460009

Espoo, 02230, Finland

Location

Investigational Site Number : 2460001

Helsinki, 00100, Finland

Location

Investigational Site Number : 2460006

Helsinki, 00930, Finland

Location

Investigational Site Number : 2460002

Jarvenpaa, 04400, Finland

Location

Investigational Site Number : 2460004

Kokkola, 67100, Finland

Location

Investigational Site Number : 2460007

Oulu, 90220, Finland

Location

Investigational Site Number : 2460003

Pori, 28100, Finland

Location

Investigational Site Number : 2460008

Tampere, 33100, Finland

Location

Investigational Site Number : 2460010

Turku, 20520, Finland

Location

Investigational Site Number : 2760011

Bönnigheim, 74357, Germany

Location

Investigational Site Number : 2760001

Bramsche, 49565, Germany

Location

Investigational Site Number : 2760007

Bretten, 75015, Germany

Location

Investigational Site Number : 2760004

Erfurt, 99086, Germany

Location

Investigational Site Number : 2760015

Hamburg, 22415, Germany

Location

Investigational Site Number : 2760002

Mönchengladbach, 41236, Germany

Location

Investigational Site Number : 2760008

Mönchengladbach, 41236, Germany

Location

Investigational Site Number : 2760006

Schönau, 83471, Germany

Location

Investigational Site Number : 2760003

Tauberbischofsheim, 97941, Germany

Location

Investigational Site Number : 3480002

Budapest, 1042, Hungary

Location

Investigational Site Number : 3480001

Budapest, 1188, Hungary

Location

Investigational Site Number : 3480005

Miskolc, 3527, Hungary

Location

Investigational Site Number : 3480006

Székesfehérvár, 8000, Hungary

Location

Investigational Site Number : 7240006

Santiago de Compostela, Galicia [Galicia], 15706, Spain

Location

Investigational Site Number : 7240001

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Investigational Site Number : 7240002

Madrid, 28007, Spain

Location

Investigational Site Number : 7240003

Seville, 41014, Spain

Location

Related Publications (1)

• 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.

  PMID: 40169489 DERIVED

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 23, 2021
• Study Start: August 23, 2022
• Primary Completion: March 9, 2023
• Study Completion (Estimated): December 26, 2027
• Last Updated: July 4, 2025
• Results First Posted: May 8, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

HU (4); DE (9); ES (4); FI (9)