Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Diphtheria; Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal polysaccharide diphtheria toxoid conjugate
Intervention description: 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 2 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Meningococcal conjugate Vaccine; Menactra®

Summary:

      This study is designed to assess the safety and immunogenicity of a single dose of
      Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
      (SP284) to support registration of the product in Japan.

      Primary Objective:

        -  To describe the seroprotection rate [% of subjects with serum bactericidal assay using
           baby rabbit complement (SBA-BR) ≥1:128] to meningococcal antigens (serogroups A, C, Y
           and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of
           age

      Secondary Objectives:

        -  To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years
           of age

        -  To describe the immune responses to meningococcal antigens (serogroups A, C, Y and
           W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 2 through 55 years on the day of inclusion

          -  For subjects ≥ 20 years of age: Informed consent form has been signed and dated by the
             subjects. For subjects 2 to 19 years of age: Informed consent form has been signed and
             dated by the parent(s) or other legal representative. Also subjects 7 to 11 years of
             age will provide assent and subjects 12 to 19 years of age will provide written assent
             form.

          -  Able to attend all scheduled visits and to comply with all trial procedures

          -  For a woman of childbearing potential, use of an effective method of contraception or
             abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after
             vaccination.

        Exclusion Criteria:

          -  Any acute and/or serious disease/illness that, in the opinion of the investigator, is
             at a stage where it might interfere with trial conduct or completion

          -  History of meningococcal diseases, confirmed either clinically, serologically, or
             microbiologically

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a life
             threatening reaction to a vaccine containing the same substances of the study vaccine

          -  Known or suspected congenital or current/ previous acquired immunodeficiency; or
             receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation
             therapy within the preceding 6 months; or long-term systemic corticosteroids therapy
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the trial inclusion

          -  Planned participation in another clinical trial during the present trial period

          -  Receipt of blood or blood-derived products in the past 3 months, which might interfere
             with assessment of the immune response

          -  Receipt of any vaccine within the four weeks preceding the trial vaccination, except
             for influenza vaccination, which may be received at least two weeks before the study
             vaccine

          -  Planned receipt of any vaccine during the trial period

          -  Clinical or known serological evidence of systemic illness including hepatitis B,
             hepatitis C and/or human immunodeficiency virus (HIV) infection

          -  Ineligible according to the investigator's clinical judgment

          -  Known pregnancy, or suspected pregnancy or a positive (serum and/or urine) pregnancy
             test

          -  Currently breast feeding a child

          -  Known thrombocytopenia, contraindicating intramuscular (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 that might interfere with the ability to
             comply with trial procedures

          -  Identified as employee of the Investigator or study center, with direct involvement in
             the proposed study or other studies under the direction of that Investigator or study
             center, as well as family member (i.e., immediate, husband, wife and their children,
             adopted or natural) of the employees or the Investigator

          -  Previous vaccination against meningococcal disease with either the trial vaccine or
             another vaccine

          -  History of Guillain-Barré Syndrome.