Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Intervention description: No vaccine will be administered in this trial
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Menactra®

Summary:

      The aim of this study is to provide information on the persistence of bactericidal antibodies
      following Menactra booster vaccination in study MTA77 ( NCT01442675).

      Objective:

        -  To evaluate the persistence of antibody responses (determined by a serum bactericidal
           assay using human complement (SBA-HC)) approximately 4 years after the administration of
           a booster dose of Menactra vaccine in trial MTA77
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥ 18 years on the day of inclusion

          -  Received booster dose of Menactra vaccine in trial MTA77

          -  Informed consent form has been signed and dated

          -  Able to attend the scheduled visit and to comply with all trial procedures.

        Exclusion Criteria:

          -  Participation at the time of trial enrollment (or in the 4 weeks preceding trial
             enrollment) in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure

          -  Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine,
             after receipt of the booster dose of Menactra vaccine administered in trial MTA77

          -  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

          -  Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating
             venipuncture at the discretion of the Investigator

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Current alcohol abuse or drug addiction

          -  Any illness that, in the opinion of the Investigator, might interfere with trial
             conduct or trial results

          -  Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood
             draw. (A prospective subject should not be included in the trial until 72 hours has
             passed.)

          -  Identified as an Investigator or employee of the Investigator or trial center with
             direct involvement in the proposed trial, 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 trial.