Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Invasive Meningococcal Disease
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine; Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined
Intervention description: 0.5 milliliter (mL), Intramuscular (IM); 0.5 mL, Subcutaneous (SC)
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 301.0
Sex: All
Minimum age: 56 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; Menactra®; Menomune® A/C/Y/W 135

Summary:

      Primary objectives:

        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135,
           measured by serum bactericidal assay using human complement (hSBA) and baby rabbit
           complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y,
           and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135.

        -  To describe the safety profile of a single dose of MenACYW Conjugate vaccine or
           Menomune® - A/C/Y/W 135.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 56 or older on the day of inclusion.

          -  Informed consent form had been signed and dated.

          -  Able to attend all scheduled visits and complied with all trial procedures.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential (were considered
             of non-childbearing potential, a female must be post-menopausal for at least 1 year,
             surgically sterile, or used an effective method of contraception or abstinence from at
             least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).

          -  Participation at the time of study enrollment (or in the 4 weeks preceding the trial
             vaccination) or planned participation during the present trial period in another
             clinical trial investigating a vaccine, drug, medical device, or medical procedure.

          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned
             receipt of any vaccine in the 4 weeks following the trial vaccination except for
             influenza vaccination, which might be received at least 2 weeks before or after the
             study vaccines.

          -  Previous vaccination against meningococcal disease with either a trial vaccine or
             another vaccine.

          -  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.

          -  At high risk for meningococcal infection during the trial.

          -  Known systemic hypersensitivity to latex or any of the vaccine components, or history
             of a severe reaction to the vaccines used in the trial or to a vaccine containing any
             of the same substances.

          -  Personal history of Guillain-Barré syndrome.

          -  Personal history of an Arthus-like reaction after vaccination with a tetanus
             toxoid-containing vaccine within at least 10 years of the proposed study vaccination.

          -  Self-reported thrombocytopenia, contraindicating IM vaccination.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating IM vaccination.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol abuse or drug addiction.

          -  Chronic illness that, in the opinion of the investigator, was at a stage where it
             might interfere with trial conduct or completion.

          -  Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (temperature ≥ 100.4°Fahrenheit [≥
             38.0°Celsius]). A prospective participant should not be included in the study until
             the condition had resolved or the febrile event had subsided.

          -  Receipt of oral or injectable antibiotic therapy within 3 days prior to any blood
             draw. Should a participant receive oral or injectable antibiotic therapy within 3 days
             prior to any blood draw, the Investigator would postpone the blood draw until it had
             been 3 days since the participant last received oral or injectable antibiotic therapy.
             Postponement must still be within the timeframe for blood draw indicated in the Table
             of Study Procedures, when possible.

          -  Identified as an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed study, 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 study.