Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children
Condition: Meningitis; Meningococcemia
MeSH terms: Diphtheria; Meningitis
Intervention: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Haemophilus Influenzae Type b (Hib) vaccine
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 2 Years
Maximum age: 4 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcemia; Neisseria meningitidis

Summary:

      The study investigated safety profile and the antibody responses to an experimental
      tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have
      received a monovalent meningococcal C conjugate vaccine at least one year previously.

      Primary objective:

      To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C
      in participants receiving Menactra® to the serogroup C antibody response in a control group
      of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28
      days following vaccination.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Participant is healthy, as determined by medical history and physical examination.

          -  Participant is 2 years to < 5 years of age at the time of vaccination.

          -  At least one year from primary vaccination with a monovalent meningococcal C conjugate
             vaccine has elapsed.

          -  Parent/Guardian has signed an Ethics Committee-approved informed consent form. A
             culturally appropriate translation will be used for non-English speaking participants
             where required.

        Exclusion Criteria :

          -  Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic,
             etc.)

          -  Known or suspected impairment of immunologic function

          -  Acute medical illness with or without fever within the last 72 hours or an axillary
             temperature ≥ 37.5ºC at the time of inclusion

          -  History of documented invasive meningococcal disease

          -  Administration of immune globulin, other blood products within the last three months,
             injected or oral corticosteroids or other immunomodulatory therapy within six weeks of
             the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting <
             7 days may be included in the trial as long as they have not received more than one
             course within the last two weeks prior to enrolment

          -  Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to
             drawing any blood sample

          -  Received any vaccine in the 28-day period prior to enrolment, or scheduled to receive
             any vaccine during enrolment in the trial

          -  Received a meningococcal C conjugate vaccine within one year prior to enrolment

          -  Suspected or known hypersensitivity to any of the vaccine components

          -  Unavailable for the entire study period or unable to attend the scheduled visits or to
             comply with the study procedures

          -  Enrolled in another clinical trial

          -  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.