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Meningococcal MeningitisPhase 3NCT06700148

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds

A Phase 3 study testing MCV4 and MPSV4 in people with Meningococcal Meningitis, run by CanSino Biologics Inc. at 2 sites in China.

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 randomized, blinded, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Read more about this study

Who is it for?
Ages 7 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Meningococcal Meningitis
What is being tested?
MCV4 and MPSV4
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
2 sitesChina
Study dates
14 Dec 2024to 16 Jul 2025
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 7 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 7~17 years old at the time of screening
  • Volunteers and their legal guardians or delegates have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete 180 days of study follow-up
  • Willingness to discuss medical history with the investigator or physician and to allow access to all medical records related to this trial

Who cannot join

  • Fever on the day of vaccination, axillary temperature >37.0°C
  • Have a moderate or severe acute illness/infection
  • Positive urine pregnancy test for females of childbearing age, or plan to become pregnant within 30 days after vaccination
  • Current meningitis or history of meningitis
  • Allergy to certain components or excipients of the drugs used in this clinical trial (mainly including: group A meningococcal podoplanoside, group C meningococcal podoplanoside, group Y meningococcal podoplanoside, group W135 meningococcal podoplanoside, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate)
  • History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
Show all 12Show fewer
  • Previous severe allergic reactions due to drugs or vaccines
  • Bleeding constitution or condition associated with prolonged bleeding, which in the opinion of the investigator makes intramuscular injection contraindicated
  • Any meningococcal vaccine in the last 1 year
  • Any other vaccine within 14 days
  • Participation in other studies involving interventional studies within 28 days (<28 days) prior to study entry and/or during study participation
  • Other conditions that, in the judgment of the investigator, make participation in this clinical trial unsuitable

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Dengfeng Center for Disease Control and Prevention

    Dengfeng

  • Kaifeng Center for Disease Control and Prevention

    Kaifeng

Other trials in China

About this study

Official title: A Randomized, Blinded, Peer-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7-17 Year Olds

This is a randomized, blinded, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups, afterwards some subjects entered the immune persistence group.

Being tested
MCV4, MPSV4
Keywords
Vaccine, Peer controlled, Immunogenicity, Safety, 7-17 years
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

  • MPSV4Biological

    1 dose of MPSV4 on Day0

Study groups in NCT06700148
Study groupRoleWhat they receive
ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197)(MCV4)ExperimentalNot described
Receives: Biological: MCV4
ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)Active comparatorNot described
Receives: Biological: MPSV4

What is being measured

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

  1. Meningococcal Antibody Positive Conversion Rates and GMT for Groups A, C, Y, and W135 in All Subjects

    Measured: 30 Days After Immunization

  2. Geometric Mean Titer (GMT) for Groups A, C, Y, and W135 in All Subjects

    Measured: 30 Days after immunization

  3. Incidence of adverse reactions in all subjects

    Measured: Within 30 mins after immunization

  4. Incidence of adverse reactions/events in all subjects

    Measured: Within 7 days after immunization

  5. Incidence of adverse reactions/events in all subjects

    Measured: Within 30 days after immunization

Secondary outcomes (8)

  1. Meningococcal antibody positivity for groups A, C, Y, and W135

    Measured: 30 days after immunization

  2. Geometric mean multiplicity of increase (GMI) for groups A, C, Y, and W135

    Measured: 30 days after immunization

  3. Antibody titer ≥1:128 ratio for groups A, C, Y, and W135

    Measured: 30 days after immunization

  4. Meningococcal Antibody Positivity for Groups A, C, Y, and W135 in Selected Subjects

    Measured: 180 days after immunization

  5. GMT for Groups A, C, Y, and W135 in Selected Subjects

    Measured: 180 days after immunization

  6. GMI for Groups A, C, Y, and W135 in Selected Subjects

    Measured: 180 days after immunization

  7. Antibody Titer ≥1:128 Ratio for Groups A, C, Y, and W135 in Selected Subjects

    Measured: 180 days after immunization

  8. Incidence of Serious Adverse Events (SAEs) for all subjects

    Measured: Within 180 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 posted21 Nov 2024
  2. Study start14 Dec 2024
  3. Primary completion19 Feb 2025
  4. Study completion16 Jul 2025

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
840 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06700148
Sponsor's protocol ID
CTP-MCVF-010
Status last verified
Aug 2026
First submitted
19 Nov 2024
Last updated
6 Aug 2026
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 MPSV4 in people with Meningococcal Meningitis, run by CanSino Biologics Inc. at 2 sites 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 12 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Meningococcal Antibody Positive Conversion Rates and GMT for Groups A, C, Y, and W135 in All Subjects (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 NCT06700148.

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 6 Aug 2026.

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