Status:
ACTIVE_NOT_RECRUITING
Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
Institute of Medical Biology, Chinese Academy of Medical Sciences
Conditions:
Hand, Foot and Mouth Disease
Eligibility:
All Genders
6-7 years
Phase:
PHASE4
Brief 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 polysaccha...
Detailed Description
This study conducts a randomized, controlled design, enrolled infants over 6 months old as the participant, and setting up three parallel groups. Participants are randomly assigned to three groups. Th...
Eligibility Criteria
Inclusion
- 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
- 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 may cause contraindications for intramuscular injection.
- Patients with severe chronic diseases.
- Known or suspected concurrent diseases include: respiratory system diseases, acute or chronic disease activity period, HIV infection in the mother or research subject of the child, cardiovascular disease, severe hypertension, malignant tumor treatment period, and skin disease patients.
- Endemic disease patients.
- Those who plan to leave their place of residence before the end of the study.
- Researchers believe that any situation that may affect observation and evaluation.
Key Trial Info
Start Date :
May 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT06209398
Start Date
May 24 2018
End Date
December 31 2025
Last Update
January 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009