Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older

Subjects will be randomized in a 1:1 ratio to receive a single dose of MenACYW conjugate
vaccine or Menomune® - A/C/Y/W-135 on Day 0 (Visit 1).

They will undergo immunogenicity assessment at baseline (pre-vaccination) and at 30 to 44
days post-vaccination and will also be evaluated for safety up to Day 180 post-vaccination.

Inclusion Criteria:

- Age ≥ 56 years on the day of inclusion

- Informed consent form has been signed and dated

- Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

- Subject is pregnant, or lactating, or of childbearing potential (to be considered of
non-childbearing potential, a female must be 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 until at least 4 weeks after vaccination)

- Participation in the 4 weeks preceding the trial vaccination 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 (28 days) preceding the trial vaccination or
planned receipt of any vaccine prior to Visit 2 except for influenza vaccination,
which may be received at least 2 weeks before or after study vaccine. This exception
includes monovalent pandemic influenza vaccines and multivalent influenza vaccines

- Previous vaccination against meningococcal disease with either the trial vaccine or
another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal
vaccine containing serogroups A, C, Y, or W; or meningococcal B 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 infection, confirmed either clinically, serologically, or
microbiologically

- At high risk for meningococcal infection during the trial (specifically, but not
limited to, subjects with persistent complement deficiency, with anatomic or
functional asplenia, or subjects travelling to countries with high endemic or epidemic
disease)

- Known systemic hypersensitivity to latex or 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

- Personal history of Guillain-Barré syndrome

- Personal history of an Arthus-like reaction after vaccination with a tetanus
toxoid-containing vaccine within at least 10 years of the proposed study vaccination

- Verbal report of thrombocytopenia, contraindicating intramuscular vaccination, in the
Investigator's opinion

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular vaccination in the Investigator's opinion

- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily

- Current alcohol abuse or drug addiction

- Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with trial conduct or completion

- Moderate or severe acute illness/infection (according to investigator judgment) on the
day of vaccination or febrile illness (temperature ≥ 100.4°F). 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 an Investigator or employee of the Investigator or study center 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.