Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
Condition: Meningococcal Immunisation (Healthy Volunteers)
Intervention: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine); Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Intervention description: Pharmaceutical form: Liquid solution Route of administration: IM; Pharmaceutical form: Liquid solution Route of administration: IM
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 2 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary Objective:

      To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A,
      C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide
      (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)
      compared with those observed following the administration of a single dose of Meningococcal
      (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®
      vaccine).

      Secondary Objective:

      Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y,
      and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or
      Menactra®.

      Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.
    

Eligibility criteria:

        Inclusion criteria :

          -  Aged 2 to 55 years on the day of inclusion.

          -  Informed consent form had been signed and dated by the participants or participants'
             parents/legally acceptable representatives as applicable. In addition: Participants 7
             to 19 years provided written assent.

          -  Participants (and participants' parents/legally acceptable representatives for the 2
             to 19 years age groups) were able to attend all scheduled visits and complied with all
             study procedures.

        Exclusion criteria:

          -  Participant was 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).

             *Effective methods of contraception included oral contraception (pill), intrauterine
             device, or condoms used with spermicide.

          -  Participation in the 4 weeks preceding the study vaccination or planned participation
             during the present study period in another clinical study investigating a vaccine,
             drug, medical device, or medical procedure.

          -  Receipt of any vaccine in the 4 weeks preceding the study 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 study 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 study (specifically, but not
             limited to, subjects with persistent complement deficiency, with anatomic or
             functional asplenia, or participants 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 study or to a vaccine containing
             any of the same substances.

          -  Laboratory confirmed / self-reported thrombocytopenia, contraindicating IM vaccination
             in the Investigator's judgment

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating IM vaccination in the Investigator's judgement.

          -  History of Guillain-Barre syndrome.

          -  History of convulsions.

          -  History of an Arthus-like reaction after vaccination with a tetanus toxoid-containing
             vaccine and a diphtheria 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, was at a stage where it
             might interfere with study conduct or completion.

          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the
             day of vaccination or febrile illness (temperature greater than or equal to (>=) 99.5
             degree Fahrenheit or >= 37.5 degree 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 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.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.