Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
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.
Study participants will receive 2 doses on Menactra® vaccine at 3 to 6 months apart and will
 be monitored for safety and immunogenicity.

 The planned duration of each subject's participation in the trial will be from 118 to 215
 days.
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.