Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT03519568
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for group Ⅰ（HepB:3+EV71）were as follows:
1. aged ≥ 6 months
2. sign the informed consent form
3. the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
4. the subjects have completed the basic immunization of 2 needle recombinant hepatitis B vaccine, there is no inoculation history of EV71 vaccine, and no history of EV71 infection
5. the last vaccination intervals ≥ 14 days
6. temperature ≤ 37℃
Inclusion criteria for group Ⅱ（MPSV-A:1+EV71）were as follows:
1. aged ≥ 6 months
2. sign the informed consent form
3. the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
4. there is no inoculation history of EV71 vaccine, and there is no history of EV71 infection
5. the last vaccination intervals ≥ 14 days
6. temperature ≤ 37℃
Inclusion criteria for group Ⅲ（MR+EV71）were as follows:
1. aged ≥ 8 months
2. sign the informed consent form
3. the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
4. there is no inoculation history of EV71 vaccine, and there is no history of EV71 infection
5. the last vaccination intervals ≥ 14 days and the last attenuated live vaccine intervals≥28days
6. temperature ≤ 37℃
Inclusion criteria for group Ⅳ（JE-L+EV71）were as follows:
1. aged ≥ 8 months
2. sign the informed consent form
3. the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
4. there is no inoculation history of EV71 vaccine, and there is no history of EV71 infection
5. the last vaccination intervals ≥ 14 days and the last attenuated live vaccine intervals ≥ 28 days
6. temperature ≤ 37℃
Exclusion Criteria:
Exclusion criteria for first needle:
1. the history or family history of anaphylaxis, convulsion, epilepsy, encephalopathy and psychosis
2. the history of severe inoculation allergies
3. patients with immunodeficiency and malignant tumors during the treatment period, receiving immunosuppressive therapy (oral steroid) or HIV due to low immunity, or family members have congenital immune disease
4. Nonspecific immunoglobulin was injected within one month
5. temperature≥37.1℃ and infectious diseases
6. the history of thrombocytopenia or other thrombocytopenia with a definite diagnosis
7. respiratory disease, acute infection or chronic disease activity period
8. severe cardiovascular disease, liver and kidney disease, and complications of diabetes
9. infectious, suppurative and allergic dermatosis
10. other conditions that may affect the evaluation of the trail
Exclusion criteria for follow-up needle:
1. any serious adverse events that have a causal relationship with the inoculation of the upper dose of the vaccine
2. the abnormality of 4 levels (local, systemic adverse reactions and vital signs) was judged to be related to vaccination
3. other new standards of exclusion criteria for first needle
4. other conditions that may affect the evaluation of the trail
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Months
Study:
NCT03519568
Study Brief:
Protocol Section:
NCT03519568