Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined
Intervention description: 0.5 milliliter (mL), Intramuscular (IM), single dose on Day 0.; 0.5 mL, Subcutaneous (SC), single dose on Day 0.
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: 907.0
Sex: All
Minimum age: 56 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; MenACYW conjugate vaccine; Menomune® - A/C/Y/W-135

Summary:

      The aim of the study was to demonstrate non-inferiority of immunogenicity and evaluate the
      safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus
      Toxoid conjugate vaccine (MenACYW conjugate vaccine) compared to a single dose of
      Meningococcal Polysaccharide Vaccine Serogroups A, C, Y, and W-135 Combined (Menomune® -
      A/C/Y/W-135) in adults 56 years of age and older in the United States.

      Primary objective:

      -To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups
      A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine
      compared to those observed following the administration of a single dose of Menomune® -
      A/C/Y/W-135.

      Secondary objective:

      -To compare the serum bactericidal assay using human complement (hSBA) antibody geometric
      mean titers of meningococcal serogroups A, C, Y, and W following the administration of
      MenACYW conjugate vaccine to those observed following the administration of Menomune® -
      A/C/Y/W-135.

      Observational objectives:

        -  To describe antibody titers against meningococcal serogroups A, C, Y, and W measured by
           hSBA at baseline (before vaccination) and 30 days after vaccination with MenACYW
           conjugate vaccine or Menomune® - A/C/Y/W-135 in a subset of 100 participants per
           treatment group.

        -  To describe the safety profile of MenACYW conjugate vaccine compared to that of the
           licensed Menomune® - A/C/Y/W-135 after a single administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥56 years on the day of inclusion.

          -  Informed consent form had been signed and dated.

          -  Attended 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 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) preceded the trial vaccination or
             planned receipt of any vaccine prior to Visit 2 except for influenza vaccination,
             which might be received at least 2 weeks before or after study vaccine. This exception
             included 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, 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 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 IM vaccination, in the
             Investigator's opinion.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating IM 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, 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 degree [°] Fahrenheit [F]).
             A prospective participant was not 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.