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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-9
SponsorCanSino Biologics Inc.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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 vector) 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Previously vaccinated with MCV4 (CanSino)

    Other intervention

    3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study at 3 and 5 years after vaccination

  • Previously vaccinated with MPSV4 (LvZhu)

    Other intervention

    3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study at 3 and 5 years after vaccination

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Previously vaccinated with MCV4 (CanSino)1 intervention
Group B: Previously vaccinated with MPSV4 (LvZhu)1 intervention

Trial outcomes

Primary outcomes

1

Geometric Mean Titers of Meningococcal Antibodies in Groups A, C, Y, and W135

Time frame
3 and 5 Years After Vaccination
2

Positivity Rates of Meningococcal Antibodies in Groups A, C, Y, and W135

Time frame
3 and 5 Years After Vaccination

Secondary outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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