Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
Intervention description: 0.5 mL, Intramuscular
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 834.0
Sex: All
Minimum age: 15 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Infection; Menactra®

Summary:

      The purpose of this trial is to describe the safety and antibody response to revaccination
      with Menactra vaccine in persons who received their first dose at ≥11 years of age.

      Primary Objective:

      - To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured
      by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in
      subjects who were first vaccinated with Menactra 4-6 years ago.

      Secondary Objective:

      - To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens
      collected 6 days post-vaccination in a subset of study population.

      Observational Objective:

      - To describe the rates of immediate reactions, solicited injection-site and systemic
      reactions, unsolicited adverse events and serious adverse events following vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received Menactra 4 to 6 years prior to enrollment, at an age ≥11 years, and is < 56
             years of age on the day of enrollment.

          -  Informed consent form has been signed and dated by the subject or by the subject and
             the parent(s) or another legally acceptable representative (and by an independent
             witness if required by local regulations).

          -  Able to attend all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Subject is pregnant, or lactating, or of child bearing potential without using an
             effective method of contraception or not practicing abstinence for at least 4 weeks
             prior to vaccination and until at least 4 weeks after vaccination. Females who are
             pre-menarche or post-menopausal for at least 1 year, or surgically sterile will not be
             excluded.

          -  Any condition which, in the opinion of the Investigator, would pose a health risk to
             the participant or interfere with the evaluation of the vaccine.

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with trial conduct or completion.

          -  History of documented invasive meningococcal disease.

          -  Participation in another interventional clinical trial investigating a vaccine, drug,
             medical device, or medical procedure in the 30 days preceding the first study
             vaccination or during the course of the study, unless no intervention for the other
             study occurred within the 30 days prior to the first study vaccination and none are
             planned before the subject would complete safety surveillance for the present study.

          -  Suspected or known hypersensitivity to latex or to any of the components of Menactra
             vaccine, or history of a life-threatening reaction to Menactra vaccine or to a vaccine
             containing any of the same substances.

          -  Receipt of any meningococcal vaccine since receipt of a single dose of Menactra
             vaccine 4-6 years prior to enrollment.

          -  Receipt of any vaccine within 30 days before receiving study vaccine, or plans to
             receive another vaccine before the Day 28 visit; except that influenza vaccine may
             have been received between 30 and 15 days (but no less than 15 days) before receiving
             study 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 six months; or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months).

          -  History of laboratory-confirmed seropositivity for Human Immunodeficiency Virus (HIV),
             Hepatitis B, or Hepatitis C, as reported by the subject.

          -  Personal history of Guillain-Barré syndrome (GBS).

          -  Laboratory-confirmed thrombocytopenia, which may be a contraindication for IM
             vaccination, at the discretion of the Investigator.

          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
             which may be a contraindication for intramuscular (IM) vaccination, at the discretion
             of the Investigator.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol or drug use that, in the opinion of the Investigator, might interfere
             with the ability to comply with trial procedures.

          -  Receipt of oral or injectable antibiotic therapy within the 72 hours prior to the
             first blood draw.

          -  Moderate or severe acute illness/infection (according to Investigator judgment) or
             febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A
             prospective subject should not be enrolled in the study until the condition has
             resolved or the febrile event has subsided.

          -  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.