CompletedNCT04450498Updated Jul 7, 2023

A Study to Demonstrate Non-inferior Immunogenicity of Yuxi Walvax MPV ACYW® Vaccine in Healthy Subjects Aged 2-10 Years

A Phase 4 interventional study of Yuxi Walvax MPV ACYW® vaccine and Sanofi Pasteur Menactra® vaccine in Neisseria Meningitides Meningitis, sponsored by Walvax Biotechnology Co., Ltd.. Completed at 1 site in Mali. Open to participants aged 2 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-07.

Sponsored by Walvax Biotechnology Co., Ltd. · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 260
Allocation: Randomized
Ages: 2 Years to 10 Years
Sex: All

Study 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.

Conditions studied

Neisseria Meningitides Meningitis

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Keywords

Neisseria Meningitidis
Non-inferior immunogenicity
Safety

In context

Meningitis, Meningococcal

113 studies on the registry are indexed under Meningitis, Meningococcal; 9 are open to participants now.

This study's enrollment of 260 is below the median of 552 across 103 interventional studies indexed under Meningitis, Meningococcal.

Browse Meningitis, Meningococcal studies →

Lead sponsor

Walvax Biotechnology Co., Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 10 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Age 2 to 10 years of age (both included)
Written informed consent obtained from the mother, father, or guardian of the child.
Free of obvious health problems and be fully vaccinated according local EPI schedule as established by medical history including physical examination and clinical judgment of the investigator.
Mother, father, or guardian capable and willing to bring their child or to receive home visits for their child for all follow-up visits.
Residence in the study area during the study period.

Exclusion criteria

Exclusion Criteria:

Vaccination against group A,C,Y,W Neisseria meningitidis in the previous 3 months
History of allergic disease or known hypersensitivity to any component of the two study vaccines.
History of serious adverse reactions following administration of vaccines included in the local program of immunization.
Administration of any other vaccine within 30 days prior to administration of study vaccines or planned vaccination during the first four weeks after the study vaccination.
Use of any investigational or nonregistered product within 60 days prior to the administration of study vaccines.
Administration of immunoglobulins and/or any blood products or planned administration during the study participation period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic or inhaled corticosteroids, this means prednisone, or equivalent, ≥0.5 mg/kg/day; topical steroids are allowed).
A family history of congenital or hereditary immunodeficiency.
History of meningitis or seizures, or any neurological disorder, convulsions, or active tuberculosis.
Major congenital defects or serious chronic illness, including malnutrition (i.e., weight less than or equal to 3 standard deviations below the mean for 2-5 years old) and immunodeficiency disorder (as per investigator's judgment)
Acute disease at the time of enrollment (acute disease being defined as the presence of a moderate or severe illness with or without fever) resulting in a temporary exclusion.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination, or laboratory tests, which in the opinion of the investigator might interfere with the well-being of the subject study objectives.
Any condition or criterion that in the opinion of the investigator might compromise the well-being of the subject or the compliance with study procedures or interfere with the outcome of the study

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 260 participants (actual)

Study arms

Experimental
Walvax MPV ACYW® vaccine group
Biological: Yuxi Walvax MPV ACYW® vaccine
Active comparator
Sanofi Pasteur Menactra® vaccine group
Biological: Sanofi Pasteur Menactra® vaccine

Interventions

BiologicalYuxi Walvax MPV ACYW® vaccine
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.
BiologicalSanofi Pasteur Menactra® vaccine
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.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Centre pour le Développement des Vaccins du Mali
Bamako, Mali

References and documents

Publications

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. PubMed 37401618 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04450498
Lead sponsor: Walvax Biotechnology Co., Ltd.
Responsible party: Sponsor
First posted: Jun 29, 2020
Start date: Dec 23, 2020
Primary completion: Jul 30, 2021
Completion: Jul 30, 2021
Last update: Jul 7, 2023

Study contacts

Samba O Sow, MD, MSc

principal investigator · Director General

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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