Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococca… (NCT06209398) | Clinical Trial Compass
UnknownPhase 4
Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine
China510 participantsStarted 2018-05-24
Plain-language summary
The main purpose of this study is to evaluate the immunogenicity and safety of inactivated enterovirus type 71 vaccine combined with recombinant hepatitis B vaccine or Group a meningococcal polysaccharide vaccine.
Who can participate
Age range
6 Months – 7 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.
Inclusion Criteria:
* Healthy children aged 6-7 months with no history of vaccination within the past month and normal intelligence.
* Healthy individuals determined by researchers after inquiring about medical history and physical examination.
* The recipients are able to comply with the requirements of the research protocol and undergo immunogenicity testing.
* Individuals without contraindications.
* Underarm temperature ≤ 37 ℃.
* Obtain informed consent from the recipient's guardian and sign an informed consent form.
Exclusion Criteria:
* Individuals with any serious illness.
* Individuals who are allergic to any ingredient in the research vaccine.
* Individuals with a history of neurological symptoms or signs.
* Individuals with bleeding constitution or prolonged bleeding time.
* Individuals who have had hand, foot, and mouth disease, hepatitis B, and epidemic cerebrospinal meningitis in the past.
* Individuals who have received other vaccines or immunoglobulin injections or any investigational drugs within the past 4 weeks.
* Infected individuals who have had any acute illness or require systemic antibiotic or antiviral treatment within the past 7 days.
* Individuals who have experienced fever (axillary temperature ≥ 38 ℃) within the past 3 days.
* Participating in another researcher.
* Individuals with a history or family history of allergies, seizures, epilepsy, encephalopathy, and mental illness.
* Patients with thrombocytopenia or other coagulation disorders that…
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
Immunogenicity of inactived Enterovirus type 71 Vaccine Combined With Hepatitis B andGroup A meningococcal polysaccharide vaccine
Timeframe: 1 month, 1 years and 5 years after full term immunization.
2
Safety of Enterovirus type 71 Vaccine Combined With Hepatitis B and Group A meningococcal polysaccharide vaccine
Timeframe: 30 minutes, 24 hours, 48 hours, and 72 hours of active follow-up, with passive reporting for 4-30 days。
Trial details
NCT IDNCT06209398
SponsorJiangsu Province Centers for Disease Control and Prevention