Dose Comparison Study of Menactra® in US Children

Study Overview
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Brief Summary
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To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children. Primary Objective: To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.

Detailed Description
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This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.

Official Title
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Exploratory Evaluation of a Two-dose Schedule Versus a One-dose Schedule of Menactra® (Meningococcal [Groups A, C, Y and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) in Children in the US

Conditions
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Meningitis, Meningococcal Infection, Neisseria Meningitidis

Intervention / Treatment
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* Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
* Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
* Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Aged 2 to < 11 years on the day of inclusion. Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative. Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures. Exclusion Criteria : Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine. Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. Planned participation in another clinical trial during the present trial period. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine . Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. Receipt of blood or blood-derived products in the past 3 months. Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial vaccination. Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s). Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity. History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically). Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination. Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws. Personal or family history of Guillain-Barré Syndrome (GBS). Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menactra® Group 1<br>Participants aged 2 to < 4 years | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate<br>* 0.5 mL, 2 doses Intramuscular<br>* Other names: Menactra®;|
| Experimental: Menactra® Group 2<br>Participants aged 4 to < 6 years | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate<br>* 0.5 mL, 2 doses Intramuscular<br>* Other names: Menactra®;|
| Active Comparator: Menactra® Group 3<br>Participants aged 6 to < 11 years | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate<br>* 0.5 mL, 1 dose Intramuscular<br>* Other names: Menactra®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) | 30 days post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) | 30 days post-vaccination | 
| Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) | 30 days post-vaccination | 
| Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. | 7 days post-vaccination 1 | 
| Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. | 7 days post-vaccination 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningitis; Meningococcal infection, Neisseria meningitidis