Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine

Study Overview
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Brief Summary
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To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier

Detailed Description
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Subjects who received one dose of Menactra® or Menomune® in study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study. All eligible subjects will provide a blood sample at Visit 1, after which their participation in the study will be terminated. An age-matched meningococcal-vaccine naïve control group will be recruited to provide a blood sample for baseline antibody level evaluation. No vaccine will be administered in this study.

Official Title
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Evaluation of the Persistence of Bactericidal Antibodies in Adolescents and Adults Who Received a Single Dose of Menactra® Four to Eight Years Earlier

Conditions
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Meningococcal Infections, Meningitis

Intervention / Treatment
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* Biological: Menactra®
* Biological: Menomune®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : For subjects aged ≥ 18 years: Informed consent form signed and dated by the subject For subjects aged < 18 years: Informed consent form signed and dated by the subject and the subject's parent/legal guardian Subject (and parent/legal guardian if subject is < 18 years of age) able to attend the scheduled visit and comply with all trial procedures For Group 1: Previously received only one dose of meningococcal vaccine (Menactra®, received in Study MTA04, MTA12, MTA19, or MTA21) For Group 2: Previously received only one dose of meningococcal vaccine (Menomune®, received in Study MTA04) For Group 3: Aged 14 through 27 years and never received any meningococcal vaccine Exclusion Criteria : Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding inclusion 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 > 2 weeks Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune responses Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositivity History of invasive meningococcal disease (confirmed either clinically, serologically, or microbiologically) For Groups 1 and 2: Previous vaccination (including booster) against meningococcal disease, with the exception of the Menactra® or Menomune® vaccination received in trial MTA04, MTA12, MTA19, or MTA21 Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent Received oral or injected antibiotic therapy within the 72 hours prior to the blood draw (temporary criteria)

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 27 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Menactra® from Previous Studies<br>Subjects previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19, or MTA21. | Biological: Menactra®<br>* 0.5 mL, Intramuscular (from a previous study)<br>|
| Group 2: Menomune® from Previous Study<br>Subjects previously received only one dose of meningococcal vaccine, Menomune® in Study MTA04 | Biological: Menomune®<br>* 0.5 mL, Intramuscular (from a previous study)<br>|
| Group 3: Control<br>Meningococcal vaccine-naive age matched subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment |  | Day 0 | 
| Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment |  | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menactra®, Menomune®, Meningitis, Meningococcal Infections