Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Meningococcal Diphtheria Toxoid Vaccine
Intervention description: 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 9 Months
Maximum age: 17 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Infection; Menactra®

Summary:

      The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine
      given as a two-dose series in infants and toddlers.

      Primary Objectives:

        -  To assess the seroprotection rate (percentage of subjects with a serum bactericidal
           assay using human complement [SBA-HC] titer ≥ 1:8) 28 days after the second of 2 doses
           of Menactra® administered 3 to 6 months apart.

      Secondary Objectives:

        -  To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135)
           28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers.

        -  To assess the safety profile of Menactra® after each and any vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 9 to 17 months on the day of inclusion

          -  Informed consent form has been signed and dated by the parent(s) or other legally
             acceptable representative(s) (if applicable)

          -  Subject and parent/legally acceptable representative (if applicable) able to attend
             all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Participation in the 4 weeks preceding inclusion or planned participation during the
             present trial period in another clinical trial investigating a vaccine, drug, medical
             device, or medical procedure.

          -  Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned
             receipt of any vaccine in the 4 weeks following each trial vaccination, except for:

          -  (i) influenza vaccination, which may be received at least 2 weeks before study
             vaccines.

          -  (ii) measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be
             administered concomitantly with the first dose of study vaccine as per routine
             immunization schedule

          -  (iii) for subjects enrolled at Indian sites: oral poliomyelitis vaccine (OPV) received
             during National Immunization Days (NIDs) and supplementary immunization activity days
             (SIADs)

          -  Previous vaccination against meningococcal disease with either the study vaccine or
             another meningococcal vaccine

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months

          -  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
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

          -  History of meningococcal diseases, confirmed either clinically, serologically, or
             microbiologically

          -  At high risk, in the opinion of the Investigator, for meningococcal disease during the
             trial

          -  Known or suspected systemic hypersensitivity to any of the vaccine components, or
             history of a life-threatening reaction to the vaccine used in the trial or to a
             vaccine containing any of the same substances

          -  Known thrombocytopenia, contraindicating intramuscular vaccination

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination

          -  In an emergency setting, or hospitalized involuntarily

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  For subjects enrolled at Indian sites: Moderate or severe acute illness/infection
             (according to investigator judgment) on the day of vaccination or febrile illness
             (temperature ≥ 38.0°C).

          -  For subjects enrolled at Russian sites: Acute disease of any severity on the day of
             vaccination or febrile illness (axillary temperature ≥ 37.0°C).

        A prospective subject should not be included in the study until the condition has resolved
        or the febrile event has subsided.

          -  Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first
             blood draw

          -  Identified as a natural or adopted child of the Investigator or employee with direct
             involvement in the proposed study

          -  Personal history of Guillain-Barré Syndrome.