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

N/ANot Yet RecruitingNCT07743411

CanSino Biologics Inc.180 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

180

Conditions

Epidemic Meningitis

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

Eligibility

Sex: ALLMin age: 7 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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