Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
Condition: Meningitis; Meningococcal Infection
MeSH terms: Diphtheria; Meningococcal Infections; Meningitis
Intervention: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Intervention description: 0.5 mL, Intramuscular (at age 9 and 12 months); 0.5 mL, Intramuscular (at age 9 and 15 months); 0.5 mL, Intramuscular (at age 12 and 15 months); 0.5 mL, Intramuscular (at age 15 months); 0.5 mL, Intramuscular (at age 18 months); 0.5 mL, Subcutaneous (at 3 years to <6 years of age)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 378.0
Sex: All
Minimum age: 9 Months
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Infection

Summary:

      The purpose of this clinical trial is to describe the safety and immunogenicity of one or two
      doses of Menactra® (TetraMenD) administered in children less than 2 years of age.

      Primary Objective:

      To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when
      administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of
      one dose of Menomune® when administered to children aged 3 years to <6 years of age.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged either 9, 12, 15 or 18 months of age or 3 to < 6 years of age on the day of
             inclusion.

          -  Informed consent form that has been approved by the site's Institutional Review Board
             (IRB) and signed by the parent or legal guardian

          -  Able to attend all scheduled visits and to comply with all trial procedures

        Exclusion Criteria :

          -  History of a serious chronic disease that could interfere with trial conduct or
             completion.

          -  Known or suspected impairment of immunologic function.

          -  Acute medical illness with or without fever within the last 72 hours, or rectal
             temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the
             day of inclusion.

          -  History of invasive meningococcal disease (confirmed either clinically, serologically
             or microbiologically) or previous meningococcal vaccination.

          -  Administration of immune globulin or other blood products within 3 months, or oral or
             parenteral corticosteroids or other immunosuppressive therapy within the last 6 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 enrollment.

          -  Antibiotic therapy within the 72 hours prior to having any blood sample drawn.

          -  Received or scheduled to receive any vaccine in the 28-day period prior to receipt of
             either dose of the study vaccine, or scheduled to receive any vaccination other than
             influenza vaccination and hyposensitization therapy in the 28-day period after receipt
             of either dose of the study vaccine. Hyposensitization therapy and influenza
             vaccination may be received up to two weeks before or after receiving the trial
             vaccine.

          -  Suspected or known hypersensitivity to any of the vaccine components or history of a
             life-threatening reaction to the trial vaccine or a vaccine containing the same
             substances.

          -  Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination

          -  Unable to attend one or more of the scheduled visits or to comply with the study
             procedures.

          -  Participation in another clinical trial in the 4 weeks preceding enrollment.

          -  Planned participation in another clinical trial during the present trial period.

          -  Any condition which, in the opinion of the investigator, would pose a health risk to
             the subject or interfere with the evaluation of the vaccine.