Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®; Meningococcal Group C Conjugate vaccine: MenC
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Infection; Menactra®; MenC

Summary:

      The purpose for this study is to demonstrate the safety and immunogenicity of two doses of
      Menactra® administered between 12 and 18 months of age and concomitantly with routine
      immunization with two different provincial schedule

      Primary Objectives:

        -  To describe the immunogenicity of Menactra® administered concomitantly with routine
           immunizations at 12 and 18 months in naïve or Menjugate-primed (MenC-primed) infants
           (measured by serum bactericidal assay using baby rabbit complement [SBA-BR])

        -  To describe the immunogenicity of MenC administered concomitantly with routine
           immunizations at 12 months of age (measured by SBA-BR)

      Secondary Objectives:

      Safety

        -  To describe the safety profile of Menactra® and MenC vaccines after each dose when given
           concomitantly with routine immunization.

      Immunogenicity

        -  To describe the immunogenicity of both vaccines using serum bactericidal assay using
           human complement [SBA-HC]

        -  To describe the immunogenicity of Pediacel administered at 18 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 12 months (365 to 400 days) on the day of inclusion

          -  Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

          -  Informed consent form has been signed and dated by the parent(s) or other legally
             authorized representative

          -  Subject and parent/legal representative are able to attend all scheduled visits and to
             comply with all trial procedures

          -  Group 1: Subject has received 3 primary vaccination doses of Pediacel as per routine
             immunization schedule

          -  Group 3: Subject has received two doses of MenC vaccine at approximately 2 and 4
             months of age as per Alberta immunization schedule.

        Exclusion Criteria:

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the first trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except
             for influenza vaccination(s), which may be received at least two weeks before study
             vaccines

          -  Planned receipt of any vaccine in the 4 weeks following any trial vaccination

          -  Previous vaccination against Meningococcal disease OR

          -  Subject has previously received only one dose of MenC vaccine, or more than two doses
             of MenC vaccine, or two doses of MenC vaccine with the most recent dose received in
             the past 6 months

          -  Receipt of blood or blood-derived products in the past 3 months which might interfere
             with assessment of the immune response

          -  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)

          -  Personal or maternal seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis
             B, or Hepatitis C, as reported by the parent/legal representative

          -  History of documented invasive meningococcal disease

          -  At high risk for 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

          -  History of contraindication to receipt of pertussis-containing vaccine

          -  Thrombocytopenia, as reported by the parent/legal representative, contraindicating
             intramuscular vaccination

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination

          -  History of seizures

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  History of Guillain-Barré Syndrome.