Active — Not RecruitingPhase 3

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

China840 participantsStarted 2024-03-01

Plain-language summary

This is a randomized, observer-blind, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups.

Who can participate

Age range

18 Years – 59 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: * 18\~59 years old at the time of screening. * Should not have received any meningococcal vaccine in the last 3 years. * Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit. * Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit. * Willingness to discuss medical history with the investigator or physician and to allow access to all medical records relevant to this trial. Exclusion Criteria: * Fever before vaccination, axillary temperature \>37.0°C. * History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders. * Volunteers with current meningitis or a history of meningitis. * Blood pregnancy-positive or breastfeeding women with a planned pregnancy within 180 days of the volunteer or her partner. * Hypersensitivity to an ingredient or excipient of the medicinal product used in this clinical trial (mainly: group A meningococcal podophyllotoxin, group C meningococcal podophyllotoxin, group Y meningococcal podophyllotoxin, group W135 meningococcal podophyllotoxin, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen p…

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

Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects

Timeframe: 30 days post immunization

Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects

Timeframe: 30 days post immunization

Incidence of adverse reactions in all subjects

Timeframe: Within 30 mins after immunization

Incidence of adverse reactions/events in all subjects

Timeframe: 7 days post immunization

Incidence of adverse reactions/events in all subjects

Timeframe: Within 30 days after immunization

Trial details

NCT IDNCT06226714

SponsorCanSino Biologics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-26

View on ClinicalTrials.gov More Meningococcal Meningitis trials

Plain-language summary

Who can participate

Age range

18 Years – 59 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.

What they're measuring

Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects

Timeframe: 30 days post immunization

Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects

Timeframe: 30 days post immunization

Incidence of adverse reactions in all subjects

Timeframe: Within 30 mins after immunization

Incidence of adverse reactions/events in all subjects

Timeframe: 7 days post immunization

Incidence of adverse reactions/events in all subjects

Timeframe: Within 30 days after immunization