A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine (NCT04689191) | Clinical Trial Compass
UnknownPhase 3
A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine
China1,280 participantsStarted 2020-09-15
Plain-language summary
This study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A and C meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 2-6 years.
Who can participate
Age range
2 Years – 50 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
. Healthy adults aged 18 to 50 years.
. Proven legal identity.
. Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
. Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
. Axillary temperature ≤37.0℃.
Exclusion criteria
. Contraindications for vaccination.
. History of allergy to vaccines or drugs.
. History of Epidemic Cerebrospinal Meningitis.
. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
. Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine within 3 years.
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
Seroconversion rate of Group A meningococcal bactericidal antibody
Timeframe: 28 days after vaccination
2
Seroconversion rate of Group C meningococcal bactericidal antibody
. Patients with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
. History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.