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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
260
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.
Centre pour le Développement des Vaccins du Mali
Bamako, Mali
Antibody response at Day 30 post-vaccination
Percentage of subjects with rSBA (Serum Bactericidal Activity using baby rabbit complement) titer ≥1:128 to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups 30 days after immunization
Time frame: Day 30 post-vaccination
Percentages of subjects with post-immunization local and systemic reactions within 7 days following vaccination in both vaccine groups
Time frame: Day 7 post-vaccination
Percentages of subjects with reported Adverse Events within 30 days following vaccination in both vaccine groups
Time frame: Day 30 post-vaccination
Percentages of subjects with reported SAEs within 6 months following vaccination in both vaccine groups
Time frame: Day 30 to Day 180 post-vaccination (end of study visit)
rSBA Geometric mean antibody titers to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups
Time frame: Day 30 post-vaccination
Percentage of subjects with rSBA titer ≥1:8 to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups 30 days after immunization
Time frame: Day 30 post-vaccination
Seroconversion rates as defined by proportion of subjects with ≥ 4-fold increase 30 days after immunization with respect to baseline of rSBA antibodies to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups 30 days after immunization
Time frame: Day 30 post-vaccination
Seroconversion rates as defined by proportion of subjects with ≥ 2-fold increase 30 days after immunization with respect to baseline of rSBA antibodies to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups
Time frame: Day 30 post-vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.