Immunology and Safety of Menactra® in Children in Saudi Arabia
Condition: Meningitis; Meningococcemia
MeSH terms: Meningitis
Intervention: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 238.0
Sex: All
Minimum age: 5 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: N. meningitidis; Meningitis; Meningococcemia

Summary:

      This study will be conducted among children in Saudi Arabia who previously received two doses
      of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal
      vaccine-naïve children (Control Group). This study will evaluate the administration of
      Menactra® in terms of the serum bactericidal antibody it induces in the two study groups.
      Safety of Menactra® vaccine will be described.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Healthy, as determined by medical history and physical examination.

          -  Aged between 5 to 8 years on the day of inclusion (from 5th birthday to 1 day before
             9th birthday inclusive).

          -  For the Booster Group , two doses of a quadrivalent (A, C, Y, W-135) meningococcal
             polysaccharide vaccine received before age 2 years

          -  For the Control Group , no previous history of any meningococcal vaccination

          -  Informed consent form signed by the parent(s) or other legal representative

          -  Able to provide a vaccination log or has available vaccination record in the Health
             Center.

          -  Able to attend all scheduled visits and to comply with all trial procedures

        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 a oral
             temperature ≥ 37.5°C at the time of inclusion.

          -  Administration of immune globulin or other blood products within the last three
             months, injected or oral corticosteroids or other immunomodulatory therapy within six
             weeks of the trial vaccine. Individuals on a tapering dose schedule of oral steroids
             lasting < 7 days may be included in the trial provided that they have not received
             more than one course within the last two weeks prior to enrollment.

          -  Oral or injected antibiotic therapy within the 72 hours prior to vaccination.

          -  Received any vaccine in the 14-day period prior to trial vaccination, or scheduled to
             receive any vaccination during the 14-day period after trial vaccination.

          -  Previous history of documented invasive meningococcal disease.

          -  For the Control Group, previous history of any meningococcal vaccination.

          -  Systemic hypersensitivity to any of the vaccines components or history of a
             life-threatening reaction to the trial vaccines or a vaccine containing the same
             substances.

          -  Participation in another clinical trial in the 4 weeks preceding the trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Any condition, which, in the opinion of the investigator, would pose a health risk to
             the subject, or interfere with the evaluation of the vaccine.

          -  Personal or family history of Guillain Barré syndrome.