Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26

Study Overview
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Brief Summary
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Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants. Objectives: To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26. To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects. To describe the safety profile of a single dose of Menactra® vaccine in subjects.

Detailed Description
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Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogenicity and safety post-vaccination.

Official Title
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Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Three Years Earlier in Study MTA26

Conditions
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Meningitis, Meningococcemia

Intervention / Treatment
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* Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
* Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
* Biological: Meningococcal polysaccharide diphtheria toxoid conjugate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Subjects received one or two doses of Menactra® vaccine in study MTA26 and provided a blood sample after the last dose received At 3 to < 6 years of age and were never vaccinated against meningococcal disease (with either the study vaccine or another vaccine). Informed consent form signed and dated by the parent(s) or another legally acceptable representative. Subject and parent/legal guardian able to attend all scheduled visits and comply with all study procedures. Exclusion Criteria : 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 study 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. Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccine or 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. Received 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 study vaccination. Planned receipt of any vaccine within the 4 weeks following the study vaccination. 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: 3 Years
Maximum Age: 6 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: One-Dose Menactra Group<br>Participants received one dose of Menactra® in Study MTA26 | Biological: Meningococcal polysaccharide diphtheria toxoid conjugate<br>* 0.5 mL, IM<br>* Other names: Menactra®;|
| Experimental: Two-Dose Menactra Group<br>Participants received two doses of Menactra® in Study MTA26 | Biological: Meningococcal polysaccharide diphtheria toxoid conjugate<br>* 0.5 mL, IM<br>* Other names: Menactra®;|
| Active Comparator: Menactra vaccine-naïve Group<br>Participants had never received Menactra® vaccine. | Biological: Meningococcal polysaccharide diphtheria toxoid conjugate<br>* 0.5 mL, IM<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 Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination. | Day 0 (pre-vaccination) and Day 30 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neisseria meningitidis, Menactra®, Meningitis, Meningococcemia