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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07743411

Enrollment

180

Registered

2026-08-03

Start date

2026-09-15

Completion date

2028-09-15

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidemic Meningitis

Keywords

ACYW135, CRM197, Immunopersistence

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.

Interventions

OTHERPreviously 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

OTHERPreviously 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 9 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Proportion of individuals with meningococcal antibody titers of ≥1:128 in serogroups A, C, Y, and W135	3 and 5 years after vaccination

Contacts

CONTACTShiwen Xu

shiwen.xu@cansinotech.com022-58213600-6051

PRINCIPAL_INVESTIGATORXiaoyu Liu

Center for Disease Prevention and Control, Shaanxi Province

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026