Epidemic MeningitisNCT07743411
A Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector)
An observational study of Epidemic Meningitis, run by CanSino Biologics Inc..
Trial summary
This study included 180 trial participants who had previously taken part in the Phase IIIb clinical trial of the ACYW135 group meningococcal polysaccharide-conjugated vaccine (CRM197 carrier) for children aged 4-6 years (Protocol No.: CTP-MCVF-002) and had completed blood sample collection at 90 and 180 days… Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Epidemic Meningitis
- What is being tested?
- Previously vaccinated with MCV4 (CanSino) and Previously vaccinated with MPSV4 (LvZhu)
- Type of treatment
- Vaccines
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 15 Sep 2028
- Phase
- Observational
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study included 180 trial participants who had previously taken part in the Phase IIIb clinical trial of the ACYW135 group meningococcal polysaccharide-conjugated vaccine (CRM197 vector) for children aged 4-6 years (Protocol No.: CTP-MCVF-002) and had completed blood sample collection at 90 and 180 days post-vaccination; there were 90 participants in each of the treatment and control groups.
Who may be able to join
- Individuals who previously participated in the Phase IIIb clinical trial of the ACYW135 group meningococcal polysaccharide-conjugated vaccine (CRM197 carrier) for children aged 4-6 years (Protocol No.: CTP-MCVF-002) and were included in both the IPS1 and IPS2 analysis sets
- Willing to provide identification documents
- Willing to provide informed consent, voluntarily sign the informed consent form, and comply with the requirements of the clinical study protocol
- The interval since completion of the vaccination series must be at least 3 years
Who cannot join
- Received another meningococcal vaccine after completion of the CTP-MCVF-002 trial
- Has thrombocytopenia, any coagulation disorder, or is currently receiving anticoagulant therapy
- Has a history of meningitis since the end of the CTP-MCVF-002 trial
- Other conditions deemed by the investigator to make the subject ineligible for this clinical study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase IV Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector)
This study included 180 trial participants who had previously taken part in the Phase IIIb clinical trial of the ACYW135 group meningococcal polysaccharide-conjugated vaccine (CRM197 carrier) for children aged 4-6 years (Protocol No.: CTP-MCVF-002) and had completed blood sample collection at 90 and 180 days post-vaccination; there were 90 participants in each of the treatment and control groups. All trial participants were required to provide 3.0-4.0 mL of blood samples for immunopersistence assessment at 3 and 5 years post-vaccination, respectively.
- Conditions
- Epidemic Meningitis
- Being tested
- Previously vaccinated with MCV4 (CanSino), Previously vaccinated with MPSV4 (LvZhu)
- Keywords
- ACYW135, CRM197, Immunopersistence
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previously vaccinated with MCV4 (CanSino)Other
3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study at 3 and 5 years after vaccination
Previously vaccinated with MPSV4 (LvZhu)Other
3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study at 3 and 5 years after vaccination
| Study group | Role | What they receive |
|---|---|---|
| Previously vaccinated with MCV4 (CanSino) | Not described Receives: Other: Previously vaccinated with MCV4 (CanSino) | |
| Previously vaccinated with MPSV4 (LvZhu) | Not described Receives: Other: Previously vaccinated with MPSV4 (LvZhu) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers of Meningococcal Antibodies in Groups A, C, Y, and W135
Measured: 3 and 5 Years After Vaccination
Positivity Rates of Meningococcal Antibodies in Groups A, C, Y, and W135
Measured: 3 and 5 Years After Vaccination
Secondary outcomes (1)
Proportion of individuals with meningococcal antibody titers of ≥1:128 in serogroups A, C, Y, and W135
Measured: 3 and 5 years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidemic MeningitisStudies of the same condition, open and under way.
- More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoyu Liu, Principal investigator, Center for Disease Prevention and Control, Shaanxi Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743411
- Sponsor's protocol ID
- CTP-MCVF-012
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector)
- ClinicalTrials.gov ID
- NCT07743411
- Acronym / sponsor ID
- CTP-MCVF-012
- Conditions
- Epidemic Meningitis
- Keywords
- ACYW135, CRM197, Immunopersistence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study included 180 trial participants who had previously taken part in the Phase IIIb clinical trial of the ACYW135 group meningococcal polysaccharide-conjugated vaccine (CRM197 carrier) for children aged 4-6 years (Protocol No.: CTP-MCVF-002) and had completed blood sample collection at 90 and 180 days post-vaccination; there were 90 participants in each of the treatment and control groups. All trial participants were required to provide 3.0-4.0 mL of blood samples for immunopersistence assessment at 3 and 5 years post-vaccination, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously vaccinated with MCV4 (CanSino) | – | Other: Previously vaccinated with MCV4 (CanSino) |
| Previously vaccinated with MPSV4 (LvZhu) | – | Other: Previously vaccinated with MPSV4 (LvZhu) |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study included 180 trial participants who had previously taken part in the Phase IIIb clinical trial of the ACYW135 group meningococcal polysaccharide-conjugated vaccine (CRM197 vector) for children aged 4-6 years (Protocol No.: CTP-MCVF-002) and had completed blood sample collection at 90 and 180 days post-vaccination; there were 90 participants in each of the treatment and control groups.
Key inclusion criteria (4 listed)
- Individuals who previously participated in the Phase IIIb clinical trial of the ACYW135 group meningococcal polysaccharide-conjugated vaccine (CRM197 carrier) for children aged 4-6 years (Protocol No.: CTP-MCVF-002) and were included in both the IPS1 and IPS2 analysis sets
- Willing to provide identification documents
- Willing to provide informed consent, voluntarily sign the informed consent form, and comply with the requirements of the clinical study protocol
- The interval since completion of the vaccination series must be at least 3 years
Key exclusion criteria (4 listed)
- Received another meningococcal vaccine after completion of the CTP-MCVF-002 trial
- Has thrombocytopenia, any coagulation disorder, or is currently receiving anticoagulant therapy
- Has a history of meningitis since the end of the CTP-MCVF-002 trial
- Other conditions deemed by the investigator to make the subject ineligible for this clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Previously vaccinated with MCV4 (CanSino)3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study at 3 and 5 years after vaccination | Other | Previously vaccinated with MCV4 (CanSino) |
| Previously vaccinated with MPSV4 (LvZhu)3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study at 3 and 5 years after vaccination | Other | Previously vaccinated with MPSV4 (LvZhu) |
Primary outcome
Geometric Mean Titers of Meningococcal Antibodies in Groups A, C, Y, and W135
Time frame: 3 and 5 Years After Vaccination
Positivity Rates of Meningococcal Antibodies in Groups A, C, Y, and W135
Time frame: 3 and 5 Years After Vaccination
1 secondary outcome
Proportion of individuals with meningococcal antibody titers of ≥1:128 in serogroups A, C, Y, and W135
Time frame: 3 and 5 years after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
Related trials for Epidemic Meningitis
Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
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Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoyu Liu principal investigator
Center for Disease Prevention and Control, Shaanxi Province
Questions about this trial
What is this clinical trial studying?
An observational study of Epidemic Meningitis, run by CanSino Biologics Inc..
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Shiwen Xu (022-58213600-6051, shiwen.xu@cansinotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Titers of Meningococcal Antibodies in Groups A, C, Y, and W135 (time frame: 3 and 5 Years After Vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.