A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
Condition: Meningococcal Infection; Meningitis
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)
Intervention description: 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 2 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal Infection; Meningitis, Bacterial; Menactra®

Summary:

      The purpose of this study is to assess the safety and immunogenicity of a single dose of
      Menactra® vaccine to support registration.

      Primary Objectives:

        -  To describe the antibody titers measured by serum bactericidal activity using baby
           rabbit complement (SBA-BR) before and after Menactra® vaccination.

        -  To describe the safety profile of participants after one dose of Menactra®.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged 2 to 11 years or Aged 12 to 17 years or Aged 18 to 55 years of age on the day of
             inclusion

          -  For participants aged 2 to 11 years: Provision of informed consent form signed by the
             parent(s) or legal representative.

          -  For participants aged 12 to 17 years: Provision of assent form signed by the
             participant and informed consent form signed by the parent(s) or legal representative.

          -  For participants aged 18 to 55 years: Provision of informed consent form signed by the
             participant. If the participant or the participant's parents or legally accepted
             representative (participants aged 2 to 17 years) are illiterate, an independent
             witness is required to sign the consent form.

          -  Participant 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 participants aged 2 to 17
             years' 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 participants aged 2 to 17
             years' 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 corticosteroids 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

          -  Current alcohol abuse or drug addiction that may interfere with the subject's ability
             to comply with trial procedures

          -  Receipt of blood or blood-derived products in the past 3 months, that might interfere
             with the assessment of immune response

          -  Receipt or planned receipt of any vaccine (other than influenza vaccine which can be
             given 2 weeks or more before vaccination) in the 4 weeks preceding or following the
             trial vaccination

          -  Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen , or
             Hepatitis C seropositivity as reported by the participant/parent/guardian and/or based
             on medical history

          -  History of documented invasive meningococcal disease

          -  Previous vaccination against meningococcal disease with either the trial vaccine or
             another vaccine

          -  Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding
             inclusion contraindicating intramuscular vaccination

          -  Subjects deprived of freedom by an administrative or court order, or in an emergency
             setting, or hospitalized without his/her consent

          -  Personal or family history of Guillain-Barré Syndrome

        Temporary contraindications delaying vaccination until resolved:

          -  Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on
             the day of vaccination

          -  Received oral or injected antibiotic therapy within the 72 hours prior to any blood
             draw