A Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector) | NCT07743411

NCT07743411

Overview

NCT ID: NCT07743411
Lead Sponsor: CanSino Biologics Inc.INDUSTRY
Official Title: Phase IV Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector)
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

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Central Contacts: Shiwen XuContact
shiwen.xu@cansinotech.com022-58213600-6051