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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walvax MPV ACYW® vaccine group | Experimental |
| |
| Sanofi Pasteur Menactra® vaccine group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yuxi Walvax MPV ACYW® vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 30 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of subjects with post-immunization local and systemic reactions within 7 days following vaccination in both vaccine groups | Day 7 post-vaccination | |
| Percentages of subjects with reported Adverse Events within 30 days following vaccination in both vaccine groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samba O Sow, MD, MSc | Director General | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre pour le Développement des Vaccins du Mali | Bamako | Mali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37401618 | Result | Sow SO, Tapia MD, Haidara FC, Diallo F, Traore Y, Traore A, Kodio M, Borrow R, Townsend-Payne K, Yuan L, Yang S, Shi L, Chen J, Fang G, Lin J, Hu R, Viviani S, Huang Z. Safety and immunogenicity of quadrivalent meningococcal polysaccharide vaccine (MPV ACYW135) compared with quadrivalent meningococcal conjugate vaccine (Menactra(R)) in Malian children. Hum Vaccin Immunother. 2023 Aug 1;19(2):2230829. doi: 10.1080/21645515.2023.2230829. Epub 2023 Jul 4. |
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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.
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The study will be carried out in an observer blind fashion until database is locked with data collected until Day 30 (Visit 3) after vaccination. The clinical study material, i.e. vaccine packs, will be packaged and encoded according to the randomization list (see Appendix B for example of vaccine labels). At study site, the investigator will assign unblinded designated person(s) responsible for vaccine handling, administration ("Vaccinator") and accountability to ensure that blinding is protected throughout the study procedures and that no other site personnel involved in the conduct of the study has access to the information. After assessment of eligibility of a new subject, the investigator will complete a form that the subject will take to the "vaccinator". The "vaccinator" will administer the vaccine according to the randomization list to the subject without informing neither the subject nor the investigator of the randomization group, i.e. the nature of the vaccine.
|
| Sanofi Pasteur Menactra® vaccine | Biological | 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. |
|
| Day 30 post-vaccination |
| Percentages of subjects with reported SAEs within 6 months following vaccination in both vaccine groups | 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 | 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 | 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 | 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 | Day 30 post-vaccination |
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
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