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 range6 Months – 7 Months
SexALL
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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…
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