A Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector)

NCT07743411 | Not Yet Recruiting

• 1 other identifier: CTP-MCVF-012
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Keywords

ACYW135; CRM197; Immunopersistence

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Titers of Meningococcal Antibodies in Groups A, C, Y, and W135

  3 and 5 Years After Vaccination

• Positivity Rates of Meningococcal Antibodies in Groups A, C, Y, and W135

  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

  3 and 5 years after vaccination

Study Arms (2)

Previously vaccinated with MCV4 (CanSino)

Other: Previously vaccinated with MCV4 (CanSino)

Previously vaccinated with MPSV4 (LvZhu)

Other: Previously vaccinated with MPSV4 (LvZhu)

Interventions

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 MCV4 (CanSino)

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

Previously vaccinated with MPSV4 (LvZhu)

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Officials

• Xiaoyu Liu

  Center for Disease Prevention and Control, Shaanxi Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiwen Xu

CONTACT

022-58213600-6051; shiwen.xu@cansinotech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07