Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults
Condition: Meningitis; Meningococcemia
MeSH terms: Meningitis
Intervention: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menactra®; Meningitis; Meningococcemia; Neisseria meningitidis

Summary:

      This study was designed to generate data for the assessment of Meningococcal Polysaccharide
      Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years.

      Primary Objective:

      To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the
      administration of one dose of the investigational Meningococcal Polysaccharide Diphtheria
      Toxoid Conjugate vaccine (Menactra®), as measured by serum bactericidal activity using baby
      rabbit complement (SBA BR) in participants in each of the two study groups.

      Secondary Objective:

      To collect reference sera for the development and refinement of laboratory assays for the
      measurement of antibody responses to serogroups Y and W 135.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Participant was at least 18 years of age but not yet 56 years of age at the time of
             vaccination.

          -  Participant had received either unconjugated meningococcal polysaccharide (serogroups
             A and C, or A, C, Y, and W 135) vaccine at least one year prior to enrollment (for
             assignment to Group 2) or had no prior history of meningococcal vaccination (for
             assignment to Group 1).

          -  Participant had signed Ethics Committee-approved informed consent form.

        Exclusion Criteria :

          -  Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic,
             psychiatric, etc.)

          -  Known or suspected impairment of immunologic function

          -  Acute medical illness with or without fever within the last 72 hours or an oral
             temperature ≥ 38°C at the time of inclusion

          -  History of documented invasive meningococcal disease

          -  Administration of immune globulin or other blood products within the last three
             months, or injected or oral corticosteroids or other immunomodulatory therapy within
             six weeks of the study vaccine. Individuals on a tapering dose schedule of oral
             steroids lasting < 7 days were allowed to be included in the trial as long as they had
             not received more than one course within the last two weeks prior to enrollment.

          -  Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to
             drawing the blood sample at Visit 2

          -  Received unconjugated meningococcal polysaccharide (serogroups A and C, or A, C, Y,
             and W 135) vaccine within the one-year period prior to enrollment or a conjugated
             meningococcal vaccine at any time prior to enrollment

          -  Received any vaccine in the 28-day period prior to enrollment, or scheduled to receive
             any vaccination during participation in the study

          -  Suspected or known hypersensitivity to any of the vaccine components

          -  Unavailable for the entire study period, or unable to attend the scheduled visits or
             to comply with the study procedures

          -  Enrolled in another clinical trial

          -  In females, pregnancy confirmed by positive urine test result

          -  In females, current breastfeeding.