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NCT07743411
A Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector)
Conditions: Epidemic Meningitis
Sex: All
Ages: 7 Years – 9 Years
Healthy volunteers: Yes
Enrollment: 180
Sponsor: CanSino Biologics Inc.
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.
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
Source: ClinicalTrials.gov (NCT07743411). StuddyBuddy aggregates publicly available trial information.