Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
Condition: Meningitis; Meningococcal Disease
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 538.0
Sex: All
Minimum age: 2 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal disease; Menactra®

Summary:

      This aim of the study is to assess post-marketing safety of a single dose of Menactra®
      vaccine with the intent to support conversion from monitored release to initial registration
      of Menactra® vaccine in the Philippines.

      Primary Objective:

      To describe the serious adverse events occurring within 30 days among participants who have
      received one dose of Menactra® vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 2 to 11 years of age on the day of inclusion (Group 1)

          -  Aged 12 to 17 years of age on the day of inclusion (Group 2)

          -  Aged 18 to 55 years of age on the day of inclusion (Group 3)

          -  Provision of informed consent form signed by the parent(s) or legal representative
             (Group 1)

          -  Provision of assent form signed by the subject and informed consent form signed by the
             parent (s) or legal representative (Group 2)

          -  Provision of informed consent form signed by the subject (Group 3)

          -  If the subject (Group 3) or the subject's parents or legally accepted representative
             (Group 1 and 2) are illiterate, an independent witness is required to sign the consent
             form

          -  Subject and parent/legally acceptable representative (if applicable) able to attend
             all scheduled visits and comply with all trial procedures

          -  For a woman of child-bearing potential, sexually active, use of a medically acceptable
             and effective method of contraception for at least 4 weeks prior to vaccination, until
             at least 4 weeks after vaccination (not applicable for females not of child-bearing
             potential or not sexually active).

        Exclusion Criteria:

          -  For a woman of child-bearing potential sexually active, known or suspected pregnancy
             or positive serum/urine pregnancy test (not applicable for females not of
             child-bearing potential or not sexually active)

          -  Breast-feeding woman

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or a medical procedure in the 4 weeks preceding the trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
             such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or
             long-term systemic corticosteroid therapy

          -  Known systemic hypersensitivity to any of the vaccine components or history of a
             life-threatening reaction to the trial vaccine or to a vaccine containing any of the
             same substances

          -  Chronic illness at a stage that could interfere with trial conduct or completion, in
             the opinion of the Investigator

          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination

          -  Planned receipt of any vaccine during the present trial period

          -  Known personal or maternal Human Immunodeficiency virus (HIV), Hepatitis B antigen or
             Hepatitis C seropositivity as reported by the subject/parent/guardian and/or based on
             medical history

          -  History of seizures

          -  Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding
             inclusion contraindicating intramuscular injection

          -  Personal of family history of Guillain-Barré Syndrome.