Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon

Study Overview
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Brief Summary
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The primary objectives of this study are: To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of MenACYW conjugate vaccine To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using human complement (hSBA) before and after a single dose of MenACYW conjugate vaccine To describe the antibody responses against tetanus toxoid at baseline and after a single dose of MenACYW conjugate vaccine To describe the safety profile of a single dose of MenACYW conjugate vaccine

Detailed Description
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Study duration per participant is approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.

Official Title
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Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older

Conditions
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Healthy Volunteers (Meningococcal Infection)

Intervention / Treatment
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* Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Aged ≥ 56 years on the day of inclusion Informed consent form has been signed and dated Able to attend all scheduled visits and to comply with all trial procedures Intending to go on a Hajj or Umrah pilgrimage (but not within the next 10 to 12 months after vaccination) Exclusion criteria: Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile). Participation 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. Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. Any previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y). Receipt of immune globulins, blood or blood-derived products in the past 3 months. 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). Known systemic hypersensitivity to any of the vaccine components, or history of a lifethreatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances . Personal history of Guillain-Barre syndrome (GBS). Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination. Verbal report thrombocytopenia, contraindicating intramuscular vaccination, in the Investigator's opinion. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. Current alcohol abuse or drug addiction. Chronic illness (eg, human immunodeficiency virus [HIV], hepatitis B, hepatitis C) 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. Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, 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: 56 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MenACYW conjugate vaccine<br>MenACYW conjugate single injection at Day 0 | Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine<br>* Pharmaceutical form: Solution for injection Route of administration: Intramuscular<br>* Other names: MenQuadfi®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W | Percentage of participants with antibody titers greater than or equal to (≥) 1:8 against meningococcal serogroups A, C, Y, and W as measured by rSBA | Day 30 (post-vaccination) | 
| Antibody titers against meningococcal serogroups A, C, Y, and W (rSBA assessment) | Antibodies titers measured by rSBA and expressed as, but not limited to, Geometric Mean Titers (GMTs) | Day 30 (post-vaccination) | 
| Antibody titers against meningococcal serogroups A, C, Y, and W (hSBA assessment) | Antibodies titers measured by hSBA and expressed as, but not limited to, GMTs | Day 30 (post-vaccination) | 
| Antibody concentrations to tetanus toxoid | Geometric Mean Concentrations (GMCs) of antibodies against tetanus toxoid | Day 0 (pre-vaccination) and Day 30 (postvaccination) | 
| Number of participants achieving seroprotective levels | Seroprotective levels defined as antibody titers ≥ 0.01 International Units (IU) / milliliters (mL) of antibody concentrations to tetanus toxoid | Day 0 (pre-vaccination) and Day 30 (postvaccination) | 
| Number of participants reporting unsolicited systemic adverse events (AEs) | Unsolicited systemic AEs reported in the 30 minutes after each vaccination | Within 30 minutes post-vaccination | 
| Number of participants reporting solicited injection site reactions and systemic reactions | Solicited (prelisted in the subject's diary card and electronic case report book [CRB]) injection site and systemic reactions occurring up to 7 days after vaccination Injection site reactions: pain, erythema and swelling Systemic reactions: fever, headache, malaise, myalgia | Within 7 days post-vaccination | 
| Number of participants reporting unsolicited non-serious AEs | Unsolicited AEs (observed AE that does not fulfill the conditions prelisted in the CRB) includes both serious (SAEs) and non-serious unsolicited AEs | Within 30 days post-vaccination | 
| Number of participants reporting serious adverse events (SAEs) | SAEs (including adverse events of special interest [AESIs]) reported throughout the study | Up to Day 30 (post-vaccination) |