Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide; Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
Intervention description: 0.5 mL, Subcutaneous; 0.5 mL, Intramuscular
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 56 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Menactra®; Menomune®; Meningococcal vaccine

Summary:

      The purpose of this trial is to describe antibody persistence and response to re-vaccination
      with either Menactra® or Menomune® vaccine approximately three years following initial
      vaccination in adults who participated in trial MTA29 (NCT00874549).

      Objectives:

        -  To describe the rates of immediate reactions, solicited injection-site and systemic
           reactions, all unsolicited adverse events, and serious adverse events following
           vaccination.

        -  To evaluate persistence of serum bactericidal antibodies in subjects who received
           Menactra® or Menomune® vaccine approximately three years ago.

        -  To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects
           re-vaccinated with either Menactra® or Menomune® vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 56 years or older on the day of inclusion.

          -  Received the appropriate Menactra or Menomune vaccine as assigned by randomization in
             Trial MTA29.

          -  Ambulatory and healthy, as determined by medical history.

          -  Informed consent form has been signed and dated.

          -  Able to attend all scheduled visits and to comply with all trial procedures.

          -  For a woman of childbearing potential, use of an effective method of contraception or
             abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after
             vaccination.

        Exclusion Criteria:

          -  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.

          -  Known pregnancy, or a positive pregnancy test.

          -  Currently breastfeeding a child.

          -  History of documented invasive meningococcal disease.

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the trial vaccination.

          -  Planned participation in another clinical trial during the present trial period.

          -  Receipt of any meningococcal vaccine since participation in trial MTA29.

          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for
             influenza vaccination, which may be received at least two weeks before trial
             vaccination.

          -  Planned receipt of any vaccine in the 4 weeks following the trial vaccination.

          -  Receipt of blood or blood-derived products in the past 3 months, which might interfere
             with assessment of the immune response.

          -  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).

          -  Laboratory-confirmed seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis
             B, or Hepatitis C.

          -  Previous personal history of Guillain-Barré Syndrome (GBS).

          -  Known systemic hypersensitivity to any of the vaccine components, latex, or history of
             a life-threatening reaction to the vaccines used in the trial or to a vaccine
             containing any of the same substances.

          -  Laboratory-confirmed thrombocytopenia, contraindicating intramuscular (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 or drug use that, in the opinion of the Investigator, might interfere
             with the ability to comply with trial procedures.

          -  Not available for the entire study period or unable to attend the scheduled visits or
             to comply with the study procedures.

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with trial conduct or completion.

          -  Identified as employees of the Investigator or study center, with direct involvement
             in the proposed study or other studies under the direction of that Investigator or
             study center, as well as family members (i.e., immediate, husband, wife and their
             children, adopted or natural) of the employees or the Investigator.