Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
Condition: Neisseria Meningitidis; Meningococcal Infections
MeSH terms: Meningococcal Infections
Intervention: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine; Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine; Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Subcutaneous; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 450.0
Sex: All
Minimum age: 16 Years
Maximum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: N meningitidis

Summary:

      This study will be conducted among adolescents in Saudi Arabia who previously received one
      dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine.
      This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and
      W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax®
      (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal
      antibody responses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, as determined by medical history and physical examination.

          -  Aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day
             before 20th birthday inclusive).

          -  For the Menactra® and Mencevax® groups, one dose of quadrivalent (A, C, Y, W 135) and
             at least one dose of bivalent (A, C) meningococcal polysaccharide vaccine with no
             meningococcal vaccine received less than 2 years prior to enrollment.

          -  For the Control group, no previous history of any meningococcal vaccination.

          -  Informed consent form signed by the parent(s) or other legal representative for
             subject under 18 years and signed by subject him/herself if subject above 18 years old

          -  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 an 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 study 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 study vaccination, or scheduled to
             receive any vaccination during the 14-day period after study vaccination.

          -  Previous history of documented invasive meningococcal disease.

          -  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.

          -  For female, known or suspected to be pregnant at the time of inclusion