A Study to Demonstrate Non-inferior Immunogenicity of Yuxi Walvax MPV ACYW® Vaccine in Healthy Subjects Aged 2-10 Years
Condition: Neisseria Meningitides Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV, single-center, observer-blind, randomized, controlled vaccine trial in 2
      to 10 years old healthy subjects. Each participant will receive a single intramuscular
      injection of one of the two vaccines either MPV ACYW® vaccine or Menactra ® vaccine according
      to the vaccine group assignment and will be followed up for one month for immunogenicity
      evaluation and for 6 months for safety evaluation.

      Statistical Hypothesis:

      H0: Seroconversion rate of test group is inferior to that of control group HA: Seroconversion
      rate of test group is non-inferior to that of control group Sample size calculation: the
      sample size was calculated based on non-inferiority test with alpha level of 0.025 and 80%
      power, assuming seroconversion rate in control group was 95% with non-inferiority margin at
      10%. The sample size required for the study is 124 per arm. After adjusting for 5% drop-out,
      the final sample size required is 130 per arm.
    


Intervention name(s): Yuxi Walvax MPV ACYW® vaccine; Sanofi Pasteur Menactra® vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Walvax MPV ACYW vaccine is a sterile formulation of polysaccharide A,C,Y,W-135. One dose of 0.5 mL contains 50 µg of each A,C,Y,W-135 purified polysaccharide. The vaccine is presented in two vials: one containing the lyophilized cake of A,C,Y,W purified polysaccharides and the other the sterile water for injection as diluent. After reconstitution the one dose of 0.5 mL is ready for subcutaneous injection. The antigen content is similar to other internationally marketed polysaccharide vaccines that have been in use for decades as Menomune® Sanofi and Mencevax® Pfizer , all containing 50 µg of each A,C,Y,W purified polysaccharide that as one dose schedule are recommended for use in subjects > 2 years of age and have shown to be safe and immunogenic.; The vaccine presentation is a full liquid formulation in a single dose of 0.5 mL with the following composition: Meningococcal group A polysaccharide 4 µg; Meningococcal group C polysaccharide 4 µg; Meningococcal group Y polysaccharide 4 µg; Meningococcal group W polysaccharide 4 µg; Diphtheria toxoid protein total 48 µg; Sodium phosphate 0.7 mg; Sodium chloride 4.35 mg.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: At Day 0, eligible subjects will be randomized in a 1:1 ratio into either Walvax MPV ACYW® vaccine group (130 subjects) or Sanofi Pasteur Menactra ® vaccine group (130 subjects). A randomization list containing subject numbers and vaccine group assignments will be provided to the investigator. Each participant will receive a single intramuscular injection of one of the two vaccines either MPV ACYW® vaccine or Menactra ® vaccine according to the vaccine group assignment and will be followed up for one month for immunogenicity evaluation and for 6 months for safety evaluation.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Neisseria Meningitidis; Non-inferior immunogenicity; Safety