Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate… (NCT05935176) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)
China660 participantsStarted 2023-09-20
Plain-language summary
The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Part 2 : Open Clinical Researchplans to enroll approximately 100 eligible participants from Part 1 who have completed immunopreservance blood sampling. Participants will receive a single booster dose of the ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) at age 3 years (but not yet 4 years).
Who can participate
Age range
6 Months – 23 Months
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.
Part Ⅰ
Inclusion Criteria:
* Children aged 6 to 23 months at the time of screening
* Volunteers who have not received any vaccine containing a epidemic encephalitis component or who have received only the group A polysaccharide flu vaccine and have been vaccinated more than 6 months since their last vaccination. 6 months or more between the last vaccination and the last vaccination
* The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol
Exclusion Criteria:
* Fever before inoculation, axillary temperature \>37.0℃
* History of epilepsy, convulsions or seizures or history of psychiatric disorders or family history
* During an acute illness episode; with a serious chronic illness or a condition that is in a progressive stage that cannot be smoothly controlled (or an acute episode)
* Known allergy to a component of the vaccine, especially to diphtheria toxoid
* Live attenuated vaccine received within 14 days or other vaccine received within 7 days prior to enrollment
* Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
* Those who had a severe allergic reaction after the previous dose of vaccine
* Those with serious adverse reactions causally related to the previous dose of vaccination
* Newly identified or newly occurred cases after the first vaccination that do not meet the inclusion …
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
Antibody positivity for A, C, Y and W135 in all subjects 6 months after 2 dose exemption
Timeframe: 6 months after 2 dose exemption
2
Seroconversion rates for serotypes A, C, Y, and W135
Timeframe: 30 days post-booster vaccination
3
Geometric mean titers (GMTs) for serotypes A, C, Y, and W135
Timeframe: 30 days post-booster vaccination
4
Increased incidence of adverse reactions
Timeframe: Within 7 days after post-booster vaccination