Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.
Condition: Meningococcal Disease; Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM
Intervention description: The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 715.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention of meningococcal disease, children, vaccine

Summary:

      This study was designed to conduct a comparative trial to further evaluate the safety,
      immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine,
      given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2
      through 10 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy children, 2 to 10 years of age who have up to date routine childhood
             vaccination, according to U.S. ACIP recommendations

        Exclusion Criteria:

          1. Unwilling or unable to give written informed assent or consent to participate in the
             study.

          2. Perceived to be unreliable or unavailable for the duration of the study period.

          3. Previous confirmed or suspected disease caused by N. meningitidis.

          4. Previously immunized with a meningococcal vaccine (licensed or investigational).

          5. Receipt of any investigational or non-registered product within 30 days prior to
             enrolment or who expect to receive an investigational drug or vaccine prior to the
             completion of the study.

          6. Receipt or plan to receive any vaccines within 30 days before and after administration
             of each dose of the study vaccine.

             (certain exceptions influenza vaccines apply)

          7. Significant acute infection within the 7 days prior to enrolment or body temperature
             of 38°C or greater within 3 days prior to enrolment.

          8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive
             neurological disease or history of Guillain-Barre syndrome.

          9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine
             components

         10. Impairment/alteration of immune function, either congenital or acquired or resulting
             from (for example):

               -  receipt of immunosuppressive therapy,

               -  receipt of immunostimulants,

               -  receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
                  derivatives.

         11. Known bleeding diathesis, or any condition that may be associated with a prolonged
             bleeding time.