Menu
Not yet recruiting NCT07743411

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

— Observational Epidemic Meningitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Previously vaccinated with MCV4 (CanSino), Previously vaccinated with MPSV4 (LvZhu).
Who it may be relevant to
Registry conditions: Epidemic Meningitis. Basic parameters: 7 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Other Previously 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
  • Other Previously 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

Primary outcome measures

  • 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 outcome measures (1)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07743411 · CTP-MCVF-012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗