Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM; MenACWY-TT
Intervention description: MenACWY-CRM; MenACWY-TT
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 202.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: meningococcal disease; children; vaccination

Summary:

      Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-cross
      reactive material (CRM) and Meningococcal ACWY-tetanus toxoid (TT) in 12-15 months old
      healthy toddlers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy children between 12 months and 15 months old inclusive who were born with an
             estimated gestational age ≥ 37 weeks.

          2. Parent(s)/legal guardian(s) had given written informed consent after the nature of the
             study had been explained according to local regulatory requirements.

          3. Parents/legal guardian available for all the visits and would comply with the
             requirements of the protocol (e.g., completion of the Diary Cards, availability for
             study visits / safety phone calls).

          4. In good health as determined by the outcome of medical history, physical examination
             and clinical judgment of the investigator.

        Exclusion Criteria:

          1. Previous confirmed or suspected disease caused by N. meningitidis.

          2. Previously exposed to clinically proven meningococcal disease or clinical bacterial
             meningitis without further microbiologic characterization, i.e. possible meningococcal
             disease.

          3. Previously immunized with a meningococcal vaccine or vaccine containing meningococcal
             antigen(s) (licensed or investigational).

          4. Received within 90 days prior to enrollment or were expected to receive during the
             study period any investigational or non-registered product (drug or vaccine).

          5. Received or planning to receive any vaccines within 14 days before and 30 days after
             administration of the study vaccine (Exceptions: Injectable influenza vaccine could be
             administered up to 14 days prior to study vaccination and at least 14 days after study
             vaccination).

          6. Major congenital defect or a serious chronic disease.

          7. History of any anaphylaxis, severe vaccine reactions, or allergy to any vaccine
             components including diphtheria toxoid (CRM197) or tetanus toxoid (TT) and latex.

          8. Required chronic administration (defined as more than 14 days) of immunosuppressants
             or other immune-modifying drugs within six months prior to the study vaccination. (For
             corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and
             topical steroids were allowed).

          9. Receipt of immunoglobulins and/or any blood products within six months prior to study
             vaccination or who had administration planned during the study period.

         10. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

         11. Any bleeding disorder which was considered as a contraindication to intramuscular
             injection.

         12. Moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within
             3 days prior to enrollment.

         13. Systemic antibiotic treatment within 7 days prior to enrollment.