Immunogenicity and Safety of Bivalent Meningococcal Serogroups A and C Tetanus Toxoid Conjugate Vaccine in Chinese
Condition: Vaccine
MeSH terms: Tetanus
Study type: Interventional
Phase: Phase 3

Summary: 
      Invasive meningococcal disease and meningococcal meningitis caused by Neisseria meningitidis
      have their highest incidence in children, with a second peak in adolescents and young adults.
      The most important disease-causing serogroups are meningococcal serogroups A (MenA) and MenC
      in Asia, such as China. The specific vaccine use in each country depends on the predominant
      serogroups, cost, and availability. conjugate vaccines are preferred to polysaccharide
      vaccines due to their impact on decreasing nasopharyngeal carriage of N. meningitidis and
      their overall increased immunogenicity in children. This clinical trial is planning to
      evaluate the immunogenicity and safety of bivalent meningococcal serogroups A and C tetanus
      toxoid conjugate vaccine in Chinese healthy children aged 3 months to 5 years.
    

Detailed description: 
      Invasive meningococcal disease and meningococcal meningitis caused by Neisseria meningitidis
      have their highest incidence in children, with a second peak in adolescents and young adults.
      The most important disease-causing serogroups are meningococcal serogroups A (MenA), MenB,
      MenC, MenW and MenY. Their prevalence varies geographically, MenA and MenC being more
      prominent in Asia. Neisseria meningitidis is one of the leading causes of bacterial
      meningitis globally. The annual number of cases related to invasive meningococcal disease
      (IMD) is estimated to be at least 1.2 million with 135 000 deaths.1 To combat IMD, an
      increasing number of countries have included vaccines against N. meningitidis in their
      routine immunization programs. The specific vaccine use in each country depends on the
      predominant serogroups, cost, and availability. Polysaccharide vaccines were used in high
      risk people in Saudi Arabia and Syria and in routine immunization in China and Egypt. In
      general, conjugate vaccines are preferred to polysaccharide vaccines due to their impact on
      decreasing nasopharyngeal carriage of N. meningitidis and their overall increased
      immunogenicity in children. This clinical trial is planning to evaluate the immunogenicity
      and safety of bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine in
      Chinese healthy children aged 3 months to 5 years.
    

Intervention name(s): experimental vaccine; Positive control vaccine 1; Positive control vaccine 2
Intervention type(s): Biological; Biological; Biological
Intervention description(s): bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD); bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(WALVAX Biological Co., LTD); bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(Royal (Wuxi) Biological Co., LTD)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention