Clinical trial
Study on the Immunogenicity and Safety of Inactivated Enterovirus Type 71 Vaccine Combined Administration With Recombinant Hepatitis B and Group A Meningococcal Vaccine
Name
JSEPI-005
Description
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.
Trial arms
Trial start
2018-05-24
Estimated PCD
2024-12-31
Trial end
2025-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell )
Used for EV71 virus susceptible individuals aged 6 months to 5 years. Each bottle (bottle) contains 0.5ml of neutralizing antibody with a potency of no less than 3.0EU for the inactivated 71 type intestinal disease vaccine. Intramuscular injection into the deltoid muscle of the upper arm. The immunization program consists of 2 doses with 1-month interval.
Arms:
Combined immunization Group, Single immunization Group
Recombinant Hepatitis B Vaccine
Each vaccine bottle (tube) is 0.5ml, containing 10ug of HBsAg and inject into the upper deltoid muscle. The immunization program consists of three doses, administered at 0, 1, and 6 months respectively. Newborns are given the first dose within 24 hours after birth, with one dose of vaccine administered each time.
Arms:
Combined immunization Group, hepatitis B and Group A meningococcal polysaccharide vaccine Group
Group A meningococcal polysaccharide vaccine
This product is made by lyophilizing the purified polysaccharide antigen obtained from Group A meningococcus liquid culture. The vaccination targets children aged 6 months to 15 years old, and the initial immunization age starts from 6 months old. Infants and young children aged 6 to 12 months old are vaccinated with 2 doses of 30 micrograms, with an interval of 3 months. Subcutaneously inject 0.5ml into the lateral deltoid muscle of the upper arm at a dose of 30 μg of polysaccharide antigen (0.5ml).
Arms:
Combined immunization Group, hepatitis B and Group A meningococcal polysaccharide vaccine Group
Size
510
Primary endpoint
Immunogenicity of inactived Enterovirus type 71 Vaccine Combined With Hepatitis B andGroup A meningococcal polysaccharide vaccine
1 month, 1 years and 5 years after full term immunization.
Safety of Enterovirus type 71 Vaccine Combined With Hepatitis B and Group A meningococcal polysaccharide vaccine
30 minutes, 24 hours, 48 hours, and 72 hours of active follow-up, with passive reporting for 4-30 days。
Eligibility criteria
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 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 510, 'type': 'ACTUAL'}}
Updated at
2024-01-17
1 organization
3 products
2 indications
Product
Enterovirus Type 71 VaccineIndication
HandIndication
Foot-and-Mouth Disease