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AzTrials

Neisseria Meningitides MeningitisPhase 4NCT04450498

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

A Phase 4 study testing Yuxi Walvax MPV ACYW® vaccine and Sanofi Pasteur Menactra® vaccine in people with Neisseria Meningitides Meningitis, run by Walvax Biotechnology Co., Ltd. at 1 site in Mali.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Neisseria Meningitides Meningitis
What is being tested?
Yuxi Walvax MPV ACYW® vaccine and Sanofi Pasteur Menactra® vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteMali
Study dates
23 Dec 2020to 30 Jul 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Mali1 site

  • Centre pour le Développement des Vaccins du Mali

    Bamako

Other trials in Mali

About this study

Official title: A Phase IV Randomized, Observer-blind, Controlled Study to Demonstrate Non-inferior Immunogenicity of Yuxi Walvax MPV ACYW® Vaccine as Compared to Sanofi Pasteur Menactra® Vaccine in Healthy Subjects Aged 2-10 Years

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.

Being tested
Yuxi Walvax MPV ACYW® vaccine, Sanofi Pasteur Menactra® vaccine
Keywords
Neisseria Meningitidis, Non-inferior immunogenicity, Safety
Medical subject headings
Meningitis, Meningococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yuxi Walvax MPV ACYW® vaccineBiological

    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.

  • Sanofi Pasteur Menactra® vaccineBiological

    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.

Study groups in NCT04450498
Study groupRoleWhat they receive
Walvax MPV ACYW® vaccine groupExperimentalNot described
Receives: Biological: Yuxi Walvax MPV ACYW® vaccine
Sanofi Pasteur Menactra® vaccine groupActive comparatorNot described
Receives: Biological: Sanofi Pasteur Menactra® vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 30 post-vaccination

Secondary outcomes (7)

  1. Percentages of subjects with post-immunization local and systemic reactions within 7 days following vaccination in both vaccine groups

    Measured: Day 7 post-vaccination

  2. Percentages of subjects with reported Adverse Events within 30 days following vaccination in both vaccine groups

    Measured: Day 30 post-vaccination

  3. Percentages of subjects with reported SAEs within 6 months following vaccination in both vaccine groups

    Measured: Day 30 to Day 180 post-vaccination (end of study visit)

  4. rSBA Geometric mean antibody titers to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups

    Measured: Day 30 post-vaccination

  5. Percentage of subjects with rSBA titer ≥1:8 to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups 30 days after immunization

    Measured: Day 30 post-vaccination

  6. 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

    Measured: Day 30 post-vaccination

  7. 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

    Measured: Day 30 post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2020
  2. Study start23 Dec 2020
  3. Primary completion30 Jul 2021
  4. Study completion30 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04450498
Sponsor's protocol ID
MPV ACYW-004
Status last verified
Jul 2023
First submitted
23 Jun 2020
Last updated
7 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Yuxi Walvax MPV ACYW® vaccine and Sanofi Pasteur Menactra® vaccine in people with Neisseria Meningitides Meningitis, run by Walvax Biotechnology Co., Ltd. at 1 site in Mali.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody response at Day 30 post-vaccination (time frame: Day 30 post-vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04450498, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.

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