Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Diphtheria; Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Intervention description: 0.5 mL, Intramuscular. 2 doses 3 months apart; 0.5 mL, Intramuscular.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 9 Months
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Menactra®; Meningococcal Vaccine

Summary:

      The aim of the study is to assess the safety of Menactra vaccine in infants, toddlers,
      children, adolescents, and adults

      Objective:

        -  To describe the safety profile after each and any dose (when applicable) of Menactra
           vaccine in participants aged 9 months to 55 years for registration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 9 months to 55 years on the day of the first study visit

          -  For adults: Informed consent form had been signed and dated by the participant For
             minors: Informed consent form had been signed and dated by the parent or legally
             acceptable representative. In addition, in accordance with the Independent Ethics
             Committee /Institutional Review Board requirements and as appropriate for the age of
             the participant, the participant may be required to sign and date the informed consent
             form if aged 12 to 17 years or assent form if aged 8 to 11 years

          -  Participant and/or parent/legally acceptable representative (if applicable) were able
             to attend all scheduled visits and to comply with all study procedures

        Exclusion Criteria:

          -  Participation at the time of study enrollment (or in the 4 weeks preceding study
             vaccination) or planned participation during the present study period in another
             clinical study investigating a vaccine, drug, medical device, or medical procedure

          -  Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned
             receipt of any vaccine in the 4 weeks following study vaccination

          -  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 (>=2
             mg/kg/day prednisone or equivalent for more than 2 consecutive weeks within the past 3
             months)

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine used in the study or to a vaccine containing
             any of the same substances

          -  Laboratory-confirmed, self-reported, or known (as reported by the parent/legally
             acceptable representative) thrombocytopenia, contraindicating intramuscular
             vaccination

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination

          -  Personal history of Guillain-Barré syndrome

          -  Chronic illness that, in the opinion of the investigator, was at a stage where it
             might interfere with study conduct or completion

          -  Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (temperature ≥ 37.5°C or ≤ 35.5°C). A
             prospective participant should not be included in the study until the condition has
             resolved or the febrile event had subsided

          -  Identified as a natural or adopted child of the Investigator or employee with direct
             involvement in the proposed study, or identified as an immediate family member (i.e.,
             parent, spouse, natural or adopted child) of the Investigator or employee with direct
             involvement in the proposed study

          -  Participant was pregnant, or lactating, or of childbearing potential (to be considered
             of non-childbearing potential, a female must be pre-menarche or post-menopausal for at
             least 1 year, surgically sterile, or using an effective method of contraception or
             abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after
             vaccination)

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Current alcohol abuse or drug addiction