Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49
Condition: Meningococcal Infection (Healthy Volunteers)
MeSH terms: Meningococcal Infections
Intervention: Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Blood sample
Intervention description: Pharmaceutical form: Solution for injection; Route of administration: Intramuscular; Blood sample for assessment of antibody persistence.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 471.0
Sex: All
Minimum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary Objective:

      To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W,
      and Y following administration of a single dose of Meningococcal Polysaccharide (Serogroups
      A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine to Group 1 participants (who
      received primary vaccination with Menomune vaccine greater than or equal to [>= 3] years
      earlier at >= 56 years of age in Study MET49).

      Secondary Objectives:

      Secondary Objective 1 - To demonstrate sufficiency of the vaccine seroresponse to
      meningococcal serogroups A, C, W, and Y following administration of a single dose of MenACYW
      Conjugate vaccine to Group 2 participants (who received primary vaccination with MenACYW
      Conjugate vaccine >= 3 years earlier at >= 56 years of age in Study MET49).

      Secondary Objective 2 - To describe vaccine seroresponse rates with respect to serogroups A,
      C, W, and Y in serum specimens collected 6 days (window, 5-7) post-vaccination in
      approximately 60 participants from Group 1 (Menomune-primed) and approximately 60
      participants from Group 2 (MenACYW Conjugate vaccine-primed).

      Secondary Objective 3 - To describe antibody persistence >= 3 years after primary vaccination
      with Menomune vaccine or MenACYW Conjugate vaccine for participants from all groups.
    

Eligibility criteria:

        Inclusion criteria:

          -  Received primary vaccination in Study MET49 or Study MET44 at >= 56 years of age with
             either Menomune vaccine or MenACYW Conjugate vaccine, as assigned by randomization.
             (">= 56 years" means from the day of the 56th birthday onwards).

          -  Able to attend all scheduled visits and to comply with all study procedures.

        Exclusion criteria:

          -  Pregnant, or lactating, or of childbearing potential and not using an effective method
             of contraception or abstinence from at least 4 weeks prior to vaccination and until at
             least 4 weeks after vaccination. To be considered of non-childbearing potential, a
             female must be post-menopausal for at least 1 year, or surgically sterile.

          -  Participation in the 4 weeks preceding study enrollment/vaccination or planned
             participation during the active phase of the present study period in another clinical
             study investigating a vaccine, drug, medical device, or medical procedure.

        Note: "Active phase" refers to the period of time from revaccination with MenACYW Conjugate
        vaccine to the end of the short-term (i.e., ~30 days) follow-up after the vaccination.
        Accordingly, following the blood draw at Visit 1, participants in Group 3 and Group 4 will
        have a 2-year inactive phase prior to Visit 2. Prior to Visit 2, participants in Group 3
        and Group 4 will have inclusion and exclusion criteria reassessed and will continue with or
        be excluded from further participation in the trial as appropriate.

          -  Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or
             planned receipt of any vaccine during the active phase of the present study except for
             influenza vaccination, which might be received at least 2 weeks before or after study
             vaccine. This exception includes monovalent pandemic influenza vaccines and
             multivalent influenza vaccines.

          -  Receipt or planned receipt of any meningococcal vaccine since receipt of a single dose
             of MenACYW Conjugate vaccine or Menomune vaccine in Study MET49 or Study MET44.

          -  Receipt of immune globulins, blood, or blood-derived products in the 3 months prior to
             either enrollment or MenACYW Conjugate vaccination in the current study.

          -  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
             prior either to enrollment or MenACYW conjugate vaccination in the current study).

          -  History of meningococcal infection, confirmed either clinically, serologically, or
             microbiologically.

          -  At high risk for meningococcal infection during the study (specifically, but not
             limited to, participants with persistent complement deficiency, with anatomic or
             functional asplenia, or participants travelling 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 vaccine used in the study or to a vaccine containing
             any of the same substances (excluding participants in Group 5 and Group 6).

          -  Verbal report of thrombocytopenia, contraindicating IM vaccination, in the
             Investigator's opinion (excluding participants in Group 5 and Group 6).

          -  Personal history of Guillain-Barré Syndrome (GBS) (excluding participants in Group 5
             and Group 6).

          -  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
             (excluding participants in Group 5 and Group 6).

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion
             (excluding participants in Group 5 and Group 6), contraindicating IM vaccination in
             the Investigator's opinion.

          -  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 >= 100.4°F). A prospective
             participant should not be included in the study or receive study vaccination 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.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.