Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
Condition: Meningococcal Disease; Meningitis
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Meningococcal (Groups A and C) Polysaccharide Vaccine; Meningococcal (Groups A and C) Polysaccharide Vaccine
Intervention description: 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 666.0
Sex: All
Minimum age: 2 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Neisseria meningitidis; Meningo A+C®; Meng Ling Kang®

Summary:

      This study is part of the post-licensure commitment to evaluate the safety and immunogenicity
      of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.

      Primary Objective:

      To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30
      days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide
      Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C)
      Polysaccharide Vaccine.

      Secondary Objective:

        -  To describe the immunogenicity for serogroups A and C, 30 days after administration of
           the study vaccines given as a single dose.

        -  To describe the full reactogenicity profile after administration of the study vaccines
           given as a single dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 2 to 6 years on the day of inclusion

          -  Informed consent form has been signed and dated by the parent or another legally
             acceptable representative

          -  Subject and parent/ legally acceptable representative are able to attend all scheduled
             visits and to comply with all trial procedures

          -  Written documentation of immunization history against meningococcal disease according
             to the national Expanded Program on Immunization (EPI) schedule (including 2 doses
             with Meningococcal Group A Polysaccharide Vaccine between 6 and 18 months of age).

        Exclusion Criteria:

          -  Participation in the 4 weeks preceding the trial vaccination or planned participation
             during the present trial period in another clinical trial investigating a vaccine,
             drug, medical device, or medical procedure

          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned
             receipt of any vaccine in the 4 weeks following the trial vaccination (except for
             influenza vaccination, which may be received at least 2 weeks before study vaccines)

          -  Previous vaccination against meningococcal disease within the past 12 months with
             either the trial vaccine or another vaccine

          -  Previous vaccination with any meningococcal conjugate vaccine.

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months

          -  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)

          -  History of meningococcal infection, confirmed either clinically, serologically, or
             microbiologically

          -  At high risk for meningococcal disease during the trial, including:

               1. persons with increased susceptibility such as persistent complement component
                  deficiencies,

               2. persons with anatomic or functional asplenia,

               3. persons who have exposure (e.g., microbiologists routinely working with N.
                  meningitidis, or travelers to or residents of areas where meningococcal disease
                  is hyperendemic or epidemic)

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccines used in the trial or to a vaccine containing
             any of the same substances

          -  Known thrombocytopenia, as reported by the parent/ legally acceptable representative,
             contraindicating intramuscular vaccination

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (axillary temperature ≥ 37.1°C). A prospective
             subject should not be included in the study until the condition has resolved or the
             febrile event has subsided

          -  Receipt of oral or injected antibiotic therapy within 72 hours before the first blood
             draw

          -  Identified as a natural or adopted child of the Investigator or employee with direct
             involvement in the proposed study

          -  Any contraindication as listed in the study vaccines leaflets.