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

Study Overview
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Brief Summary
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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.

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

Official Title
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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.

Conditions
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Meningococcal Immunisation (Healthy Volunteers)

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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<br>* Liquid solution for injection Intramuscular<br>* Other names: MenACYW conjugate vaccine MenQuadfi®;|
| Experimental: Group 2<br>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<br>* Liquid solution for injection Intramuscular<br>* Other names: MenACYW conjugate vaccine MenQuadfi®;|

What is the study measuring?
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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) |