AzTrials
AzTrials

Epidemic MeningitisPhase 3NCT06011200

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a 4 to 6 Year-old Population

A Phase 3 study testing MCV4 and MSPV4 in people with Epidemic Meningitis, run by CanSino Biologics Inc. at 1 site in China.

Completed

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

Official record
Search all trials

Trial summary

The scientific name of meningococcus is Neisseria meningitidis (Nm), the causative agent of epidemic meningococcal meningitis (rheumatoid encephalitis), which colonizes the mucous membranes of the human nasopharynx or causes local infection and can cross the mucosal barrier to cause invasive bacteremia or epidemic… Read more about this study

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Epidemic Meningitis
What is being tested?
MCV4 and MSPV4
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteChina
Study dates
16 Sep 2023to 11 May 2024
Phase
Phase 3
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 4 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children aged 4~6 years old
  • Complete at least two doses of basic immunization with polysaccharide influenza vaccine according to the immunization program
  • The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol

Who cannot join

  • Fever before inoculation, axillary temperature >37.0℃
  • Previous history of immunization with meningococcal polysaccharide conjugate vaccine
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • History of epilepsy, convulsions or seizures or a history of psychiatric illness or family history
  • Volunteers with current meningitis or a history of meningitis
  • Volunteers treated with immunosuppressive therapy, cytotoxic therapy, glucocorticoids (excluding topical treatment, surface treatment for acute uncomplicated dermatitis, spray treatment for allergic rhinitis) within the past 6 months (<6 months)
Show all 15Show fewer
  • Received blood/plasma products or immunoglobulins within 60 days (<60 days) prior to study vaccination or planned to receive blood/plasma products or immunoglobulins throughout the study period
  • Suffering from serious chronic diseases or conditions that are in a progressive stage and cannot be controlled smoothly, such as thyroid disease
  • Volunteers with known or suspected diseases that are judged by the investigator to affect vaccination such as severe respiratory disease, acute infection or active chronic disease, severe cardiovascular disease, severe liver or kidney disease, malignancy, severe infectious or allergic skin disease
  • History of serious adverse reactions associated with the vaccine and/or history of severe allergic reactions (e.g., systemic allergic reactions) to any component of the investigational vaccine
  • Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., malignancy, HIV, etc.)
  • Bleeding constitution or condition associated with prolonged bleeding, investigators consider intramuscular injection to be contraindicated
  • Live attenuated vaccine given within 14 days, other vaccines given within 7 days
  • Participation in other studies involving interventions within 28 days (<28 days) prior to study entry and/or during study participation
  • Other conditions judged by the investigator to be inappropriate for participation in this clinical trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanyang County Center for Disease Prevention and Control

    Shanyang, Shaanxi

Other trials in China

About this study

Official title: A Randomized, Blinded, Comparable Vaccine-controlled Phase IIIb Clinical Trial to Evaluate the Safety and Immunogenicity of Meningococcal Polysaccharide Conjugate Vaccine, Group ACYW135 (CRM197 Vector), in a 4 to 6 Year-old Population

The scientific name of meningococcus is Neisseria meningitidis (Nm), the causative agent of epidemic meningococcal meningitis (rheumatoid encephalitis), which colonizes the mucous membranes of the human nasopharynx or causes local infection and can cross the mucosal barrier to cause invasive bacteremia or epidemic meningococcal meningitis, meningococcus can often cause serious disease epidemics worldwide, the main clinical features of its infection are fever, rash and meningitis, the most common clinical manifestation is acute bacterial meningitis.

Read the detailed description

The preventive measures for influenza are based on strengthening personal protection, vaccination, strengthening surveillance, early detection of patients, and active isolation and treatment. The immune response to meningococcal polysaccharide vaccine is weak in infants under 2 years of age, and only a transient immune response is produced. Numerous experiments have shown that the immunogenicity of polysaccharides is enhanced by binding to protein carriers, and a significant booster effect is produced. Meningococcal polysaccharide conjugate vaccine induces a good immune response in infants and children under 2 years of age and produces immune memory, which enhances the immune effect of the vaccine and can eliminate the carrier state of infected patients.

Being tested
MCV4, MSPV4
Keywords
ACYW135, CRM197, Immunogenicity, Safety, 4~6 yearsof age
Medical subject headings
Meningitis, Meningococcal

What participants receive

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

  • MCV4Biological

    1 dose of MCV4 on Day 0

  • MSPV4Biological

    1 dose of MSPV4 on Day 0

Study groups in NCT06011200
Study groupRoleWhat they receive
ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)ExperimentalIntramuscular injection, 0.5ml
Receives: Biological: MCV4
ACYW135 Group Meningococcal Polysaccharide Vaccine (MSPV4)Active comparatorSubcutaneous injection, 0.5ml
Receives: Biological: MSPV4

What is being measured

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

  1. Geometric mean titers (GMT) of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization

    Measured: 30 days after immunization

  2. Positive conversion rates of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization

    Measured: 30 days after immunization

  3. Incidence of adverse reactions within 30 minutes after immunization in all subjects

    Measured: Within 30 minutes after immunization

  4. Incidence of adverse reactions/events within 7 days of immunization for all subjects

    Measured: Within 7 days after immunization

  5. Incidence of adverse reactions/events within 30 days of exemption for all subjects

    Measured: Within 30 days of exemption

Secondary outcomes (9)

  1. Meningococcal positivity for groups A, C, Y, and W135 for all subjects 30 days after immunization

    Measured: 30 days after immunization

  2. Geometric mean growth multiplier (GMI) for all subjects 30 days after immunization

    Measured: 30 days after immunization

  3. Antibody titers ≥1:128 ratio for all subjects 30 days after immunization

    Measured: 30 days after immunization

  4. Meningococcal antibody positivity for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects

    Measured: 90 and 180 days of exemption

  5. GMT for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects

    Measured: 90 and 180 days of exemption

  6. GMI for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects

    Measured: 90 and 180 days of exemption

  7. Antibody titers ≥1:128 ratio for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects

    Measured: 90 and 180 days of exemption

  8. Incidence of serious adverse events (SAEs) within 180 days of exemption in all subjects

    Measured: Within 180 days of exemption

  9. All subjects were stratified into susceptible (<1:8) and non-susceptible (≥1:8) populations according to the 1:8 pre-immune antibody titer threshold

    Measured: 30 days after immunization

Timeline

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

  1. First posted25 Aug 2023
  2. Study start16 Sep 2023
  3. Primary completion11 Dec 2023
  4. Study completion11 May 2024

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06011200
Sponsor's protocol ID
CTP-MCVF-002
Status last verified
Mar 2025
First submitted
15 Aug 2023
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MCV4 and MSPV4 in people with Epidemic Meningitis, run by CanSino Biologics Inc. at 1 site in China.

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 3 inclusion and 15 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 3 Jul 2025. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Geometric mean titers (GMT) of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization (time frame: 30 days after immunization). The study lists 5 primary outcomes in all. 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 NCT06011200.

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 3 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in