ClinicalTrials.gg
Not yet recruitingNCT07743411Updated Aug 3, 2026

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

An observational study in Epidemic Meningitis, sponsored by CanSino Biologics Inc.. Not yet recruiting. Open to participants aged 7 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by CanSino Biologics Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
7 Years to 9 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Epidemic Meningitis

Keywords

  • ACYW135
  • CRM197
  • Immunopersistence
03

In context

Meningitis, Meningococcal

125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.

This study's planned enrollment of 180 is close to the median of 180 across 11 observational studies indexed under Meningitis, Meningococcal.

Browse Meningitis, Meningococcal studies →

Lead sponsor

CanSino Biologics Inc. is the lead sponsor of 41 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • Previously vaccinated with MCV4 (CanSino)

    Other: Previously vaccinated with MCV4 (CanSino)

  • Previously vaccinated with MPSV4 (LvZhu)

    Other: Previously vaccinated with MPSV4 (LvZhu)

Interventions

  • OtherPreviously 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

  • OtherPreviously 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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07743411
Responsible party
Sponsor
First posted
Aug 3, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Sep 15, 2028 (estimated)
Completion
Sep 15, 2028 (estimated)
Last update
Aug 3, 2026

Study contacts

Shiwen Xu
Contact
shiwen.xu@cansinotech.com
022-58213600-6051
Xiaoyu Liu
principal investigator · Center for Disease Prevention and Control, Shaanxi Province

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion