Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

Healthy meningococcal-vaccine naïve adolescents and adults will be enrolled, randomized and
will receive a single dose of either MenACYW conjugate vaccine from 1 of the 3 lots (Lot 1,
Lot 2, or Lot 3) or licensed MCV4 vaccine. They will be assessed for immunogenicity at
baseline (pre-vaccination) and at 1 month post-vaccination. Safety information will be
collected post-vaccination and through the entire study.

Inclusion Criteria:

- Aged 10 to 55 years on the day of inclusion

- Informed consent form has been signed and dated by the subject (aged 18 to 55 years)
or assent form has been signed and dated by the subject and informed consent form has
been signed and dated by the parent(s) or guardian (for subjects aged 10 to < 18
years)

- Subject (≥ 18 years) or subject (10 to < 18 years) and parent / guardian are 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 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 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 the study investigational
vaccines. 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 traveling to countries with high endemic or epidemic
disease)

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccines used in the trial or to a vaccine
containing any of the same substances

- Verbal report of thrombocytopenia, as reported by the subject or the subject's parent
/ guardian, 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

- Personal history of Guillain-Barre syndrome

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

- 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.