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

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.

The purpose of the MEQ00073 study is to describe the immunogenicity and safety of a booster dose and persistence of a priming dose of MenACYW conjugate vaccine (MenQuadfi®) in adolescents who had been vaccinated approximately 10 years earlier as toddlers as part of the MET51 study and to describe the immunogenicity and safety of a second booster dose (as adolescents approximately 5 years after the first booster dose) and the persistence of a first booster dose of MenACYW in adolescents who had been primed with MenACYW conjugate vaccine as toddlers as part of the MET51 study and had received a first booster dose as children approximately 5 years after the priming dose.

Study Overview

• Status: Active, not recruiting
• Conditions: Meningococcal Immunisation (Healthy Volunteers)
• Intervention / Treatment: Biological: Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland, 02230
    • Investigational Site Number :2460009
  • Helsinki, Finland, 00100
    • Investigational Site Number :2460001
  • Helsinki, Finland, 00930
    • Investigational Site Number :2460006
  • Järvenpää, Finland, 04400
    • Investigational Site Number :2460002
  • Kokkola, Finland, 67100
    • Investigational Site Number :2460004
  • Oulu, Finland, 90220
    • Investigational Site Number :2460007
  • Pori, Finland, 28100
    • Investigational Site Number :2460003
  • Tampere, Finland, 33100
    • Investigational Site Number :2460008
  • Turku, Finland, 20520
    • Investigational Site Number :2460010
• Germany
  • Bramsche, Germany, 49565
    • Investigational Site Number :2760001
  • Bretten, Germany, 75015
    • Investigational Site Number :2760007
  • Bönnigheim, Germany, 74357
    • Investigational Site Number :2760011
  • Erfurt, Germany, 99086
    • Investigational Site Number :2760004
  • Goch, Germany, 47574
    • Investigational Site Number :2760009
  • Hamburg, Germany, 22415
    • Investigational Site Number :2760015
  • Mönchengladbach, Germany, 41236
    • Investigational Site Number :2760002
  • Mönchengladbach, Germany, 41236
    • Investigational Site Number :2760008
  • Schönau, Germany, 83471
    • Investigational Site Number :2760006
  • Tauberbischofsheim, Germany, 97941
    • Investigational Site Number :2760003
• Hungary
  • Budapest, Hungary, 1042
    • Investigational Site Number :3480002
  • Budapest, Hungary, 1188
    • Investigational Site Number :3480001
  • Miskolc, Hungary, 3527
    • Investigational Site Number :3480005
  • Szeged, Hungary, 6723
    • Investigational Site Number :3480003
  • Székesfehérvár, Hungary, 8000
    • Investigational Site Number :3480006
• Spain
  • Madrid, Spain, 28007
    • Investigational Site Number :7240002
  • Sevilla, Spain, 41014
    • Investigational Site Number :7240003
  • Galicia [Galicia]
    • Santiago de Compostela, Galicia [Galicia], Spain, 15706
      • Investigational Site Number :7240006
  • Madrid, Comunidad De
    • Madrid, Madrid, Comunidad De, Spain, 28046
      • Investigational Site Number :7240001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine; Liquid solution for injection Intramuscular; Other Names: MenACYW conjugate vaccine MenQuadfi®
Experimental: Group 2; 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; Liquid solution for injection Intramuscular; Other Names: MenACYW conjugate vaccine MenQuadfi®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine seroresponse against meningococcal serogroups A, C, W, and Y	Antibody titers measured by serum bactericidal assay using human complement (hSBA) Seroresponse defined as the proportions of participants with an hSBA pre-vaccination titer < 1:8 who achieved a post-vaccination titer ≥ 1:16 or participants with a pre-vaccination titer ≥ 1:8 who achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer	Visit 01 (baseline) and Visit 2 (30 days after the administration of a 5-year booster dose (Group 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody titers against meningococcal serogroups A, C, W, and Y before the administration of a booster dose of MenACYW conjugate vaccine (Group 1 and 2)	Antibody titers measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA)	Visit 1 (baseline) for Group 1 and Group 2
Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 (Group 2)	Antibody titers measured by hSBA and rSBA	Visit 2 (60 months after baseline) for Group 2
Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 (Group 1)	Antibody titers measured by hSBA and rSBA	Visit 3 (60 months after the administration of a 5-year booster dose) for Group 1
Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 1 and Visit 2 (Group 1)	Antibody titers measured by hSBA and rSBA	Visit 1 (baseline) and Visit 2 (30 days after the administration of 5-year booster dose of MenACYW conjugate vaccine) (Group 1)
Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 and Visit 3 (Group 2)	Antibody titers measured by hSBA and rSBA	Visit 2 (60 months after baseline) and Visit 3 (30 days after the administration of a 10-year booster dose of MenACYW conjugate vaccine) (Group 2)
Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 and Visit 4 (Group 1)	Antibody titers measured by hSBA and rSBA	Visit 3 (60 months after the administration of 5-year booster dose) and Visit 4 (30 days after the administration of 10-year booster dose of MenACYW conjugate vaccine) (Group 1)
Antibody concentrations against tetanus toxoid at Visit 1 and Visit 2 (Group 1)	Antibody concentration measured by immunoglobulin (Ig)G enzyme-linked immunosorbent assay (ELISA)	Visit 1 (baseline) and Visit 2 (30 days after the administration of a 5-year booster dose of MenACYW conjugate vaccine) (Group 1)
Antibody concentrations against tetanus toxoid at Visit 3 and Visit 4 (Group 1)	Antibody concentration measured by immunoglobulin (Ig)G enzyme-linked immunosorbent assay (ELISA)	Visit 3 (60 months after the administration of 5-year booster dose) and Visit 4 (30 days after the administration of the 10-year booster dose of MenACYW conjugate vaccine) (Group 1)
Antibody concentrations against tetanus toxoid at Visit 2 and Visit 3 (Group 2)	Antibody concentration measured by immunoglobulin (Ig)G enzyme-linked immunosorbent assay (ELISA)	Visit 2 (60 months after the baseline) and Visit 3 (30 days after administration of a 10-year booster dose of MenACYW conjugate vaccine) (Group 2)
Antibody titers against meningococcal serogroup C Visit 3 and Visit 4 (Group 1)	Antibody titers measured by hSBA and rSBA	Visit 3 (60 months after the administration of 5-year booster dose) and Visit 4 (30 days after the administration of 10-year booster dose of MenACYW conjugate vaccine) (Group 1)
Antibody titers against meningococcal serogroups C Visit 2 and Visit 3 (Group 2)	Antibody titers measured by hSBA and rSBA	Visit 2 (60 months after the baseline) and Visit 3 (30 days after administration of a 10-year booster dose of MenACYW conjugate vaccine) (Group 2)
Number of participants with immediate adverse events (AEs)	Unsolicited systemic AEs reported within 30 minutes after vaccination	Within 30 minutes after vaccination
Number of participants with solicited injection site reactions or systemic reactions	Pre-defined adverse reactions Injection site reactions: pain, redness and swelling Systemic reactions: fever, headache, malaise, myalgia	Within 7 days after vaccination
Number of participants with unsolicited AEs	AEs other than solicited reactions	Within 30 days after vaccination
Number of participants with serious adverse events (SAEs)	SAEs (including adverse events of special interest [AESIs]) reported throughout the study	From baseline until the End of Study (up to 5.5 years)

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Actual): March 9, 2023
• Study Completion (Estimated): December 26, 2027

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: MEQ00073; U1111-1255-4941 (Registry Identifier: ICTRP); 2021-000104-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes