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

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.

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Key information

Conditions

Epidemic Meningitis Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Meningitis Meningitis, Bacterial Meningitis, Meningococcal Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Previously vaccinated with MPSV4 (LvZhu)

Other

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Shiwen Xu

CONTACT

[email protected]

022-58213600-6051

Sponsors and collaborators

Lead sponsor

CanSino Biologics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Aug 3, 2026
Registry last updated: Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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