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Meningococcal MeningitisPhase 3NCT06226714

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

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

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a randomized, observer-blind, 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 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Meningococcal Meningitis
What is being tested?
MCV4 and MPSV4
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
3 sitesChina
Study dates
1 Mar 2024to Aug 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18~59 years old at the time of screening.
  • Should not have received any meningococcal vaccine in the last 3 years.
  • Volunteers 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 the 180-day study follow-up visit.
  • Volunteers 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 the 180-day study follow-up visit.
  • Willingness to discuss medical history with the investigator or physician and to allow access to all medical records relevant to this trial.

Who cannot join

  • Fever before vaccination, axillary temperature >37.0°C.
  • History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders.
  • Volunteers with current meningitis or a history of meningitis.
  • Blood pregnancy-positive or breastfeeding women with a planned pregnancy within 180 days of the volunteer or her partner.
  • Hypersensitivity to an ingredient or excipient of the medicinal product used in this clinical trial (mainly: group A meningococcal podophyllotoxin, group C meningococcal podophyllotoxin, group Y meningococcal podophyllotoxin, group W135 meningococcal podophyllotoxin, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate).
  • Severe hypertension uncontrolled by medication (at on-site measurement: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
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  • Previous vaccination-related hospitalizations or emergencies.
  • Bleeding constitution or condition associated with prolonged bleeding that investigators consider contraindicated for intramuscular injection.
  • Other vaccinations within 14 days.
  • Participation in other studies involving interventional studies within 28 days prior to study entry (<28 days) and/or during study participation.
  • Other circumstances that, in the judgment of the investigator, make participation in this clinical trial inappropriate.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Jiangjin District Center for Disease Control and Prevention

    Chongqing

  • Wanzhou District Center for Disease Control and Prevention

    Chongqing

  • Yuzhong District Center for Disease Control and Prevention

    Chongqing

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 a Population Aged 18-59 Years

This is a randomized, observer-blind, 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.

Being tested
MCV4, MPSV4
Keywords
Vaccine, Peer controlled, Immunogenicity, Safety, 18-59 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 MSPV4 on Day 0

Study groups in NCT06226714
Study groupRoleWhat they receive
ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)ExperimentalIntramuscular injection, 0.5ml
Receives: Biological: MCV4
ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)Active comparatorSubcutaneous iniection, 0.5ml
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 for groups A, C, Y, and W135 in all subjects

    Measured: 30 days post immunization

  2. Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects

    Measured: 30 days post 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: 7 days post immunization

  5. Incidence of adverse reactions/events in all subjects

    Measured: Within 30 days after immunization

Secondary outcomes (9)

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

    Measured: 30 days post immunization

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

    Measured: 30 days post immunization

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

    Measured: 30 days post 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) in all subjects

    Measured: Within 180 days after immunization

  9. Incidence of pregnancy events in 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 posted26 Jan 2024
  2. Study start1 Mar 2024
  3. Primary completion26 Sep 2024
  4. Study completionAug 2025 (estimated)

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
NCT06226714
Sponsor's protocol ID
CTP-MCVF-003
Status last verified
Mar 2025
First submitted
18 Jan 2024
Last updated
29 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 MPSV4 in people with Meningococcal Meningitis, run by CanSino Biologics Inc. at 3 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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 29 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 3 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?

This study is still under way. Results are not available in the source record yet.

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 for groups A, C, Y, and W135 in all subjects (time frame: 30 days post 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 NCT06226714.

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 29 Jul 2025.

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