A Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vec… (NCT07743411) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector)
180 participantsStarted 2026-09-15
Plain-language 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.
Who can participate
Age range
7 Years – 9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric Mean Titers of Meningococcal Antibodies in Groups A, C, Y, and W135
Timeframe: 3 and 5 Years After Vaccination
2
Positivity Rates of Meningococcal Antibodies in Groups A, C, Y, and W135