Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea
Condition: Meningitis; Meningococcal Disease
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®); Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 11 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal disease; Menactra®; Adacel®

Summary:

      The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in
      support of registration of the vaccine in South Korea.

      Primary Objective:

        -  To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y
           and W-135, 28 days after a single dose of Menactra®.

      Secondary objectives:

        -  To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion
           rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine

        -  To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine.

        -  To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers
           before and 28 days after a single dose of Menactra® or Adacel® vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 11 to 55 years on the day of inclusion

          -  Subject aged 11 to 19 years: assent form signed and dated by the subject and informed
             consent form signed and dated by at least 1 parent or another legal representative

          -  Subject aged 20 to 55 years: informed consent form signed and dated by the subject

        If the subject or the subject's parent(s) or legal representative is illiterate, an
        independent witness is required to sign the consent form.

          -  Subject and parent/legally acceptable representative (if applicable) are able to
             attend all scheduled visits and comply with all trial procedures

          -  Covered by health insurance.

        Exclusion Criteria:

          -  Subject is pregnant, or lactating, or of child-bearing potential (to be considered of
             non-childbearing potential, a female must be pre-menarche or post menopausal for at
             least 1 year, surgically sterile (hysterectomy or bilateral tubal ligation), or using
             an effective method of contraception or abstinence for at least 4 weeks prior to
             vaccination, until at least 4 weeks after vaccination)

          -  Participation 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 a medical procedure

          -  Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the
             trial vaccination. Monovalent pandemic influenza vaccines and multivalent pandemic
             influenza vaccines can be administered at any time during the study

          -  Previous vaccination against meningococcal disease with either the trial vaccine or
             another vaccine

          -  Vaccination against diphtheria or tetanus in the past 5 years or any previous
             vaccination with either Adacel® or any other Tdap 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 invasive meningococcal disease, confirmed either clinically, serologically,
             or microbiologically

          -  At high risk for invasive meningococcal disease during the trial

          -  Known systemic hypersensitivity to any of the vaccine components or history of a
             life-threatening reaction to the vaccines used in the trial or to a vaccine containing
             any of the same substances

          -  Thrombocytopenia, bleeding disorder or receipt of anticoagulants in the 3 weeks
             preceding inclusion, contraindicating intramuscular 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 at a stage that could interfere with trial conduct or completion, in
             the opinion of the investigator

          -  Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject
             should not be included in the study until the condition has resolved or the febrile
             event has subsided

          -  Received oral or injectable antibiotic therapy within the 72 hours prior to the first
             blood draw

          -  Identified as an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed, 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

          -  Personal history of Guillain-Barré Syndrome.