Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
Primary objectives:

 -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135,
 measured by serum bactericidal assay using human complement (hSBA) and baby rabbit
 complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y,
 and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135.

 -  To describe the safety profile of a single dose of MenACYW Conjugate vaccine or
 Menomune® - A/C/Y/W 135.
All participants received a single dose of their assigned vaccine on Day 0. They were
 assessed for immunogenicity on Day 0 and Day 30, and monitored for safety throughout the
 study.
Inclusion Criteria:

 -  Aged 56 or older on the day of inclusion.

 -  Informed consent form had been signed and dated.

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

 Exclusion Criteria:

 -  Participant was pregnant, or lactating, or of childbearing potential (were considered
 of non-childbearing potential, a female must be post-menopausal for at least 1 year,
 surgically sterile, or used an effective method of contraception or abstinence from at
 least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).

 -  Participation at the time of study enrollment (or 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 preceding the trial vaccination or planned
 receipt of any vaccine in the 4 weeks following the trial vaccination except for
 influenza vaccination, which might be received at least 2 weeks before or after the
 study vaccines.

 -  Previous vaccination against meningococcal disease with either a trial vaccine or
 another 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.

 -  Known systemic hypersensitivity to latex or any of the vaccine components, or history
 of a severe reaction to the vaccines 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.

 -  Self-reported thrombocytopenia, contraindicating IM vaccination.

 -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
 contraindicating IM 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, was 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°Fahrenheit [≥
 38.0°Celsius]). A prospective participant should not be included in the study until
 the condition had resolved or the febrile event had subsided.

 -  Receipt of oral or injectable antibiotic therapy within 3 days prior to any blood
 draw. Should a participant receive oral or injectable antibiotic therapy within 3 days
 prior to any blood draw, the Investigator would postpone the blood draw until it had
 been 3 days since the participant last received oral or injectable antibiotic therapy.
 Postponement must still be within the timeframe for blood draw indicated in the Table
 of Study Procedures, when possible.

 -  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.