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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT04439435
Eligibility Criteria:
Inclusion Criteria:
* Children who are 1-15 years old in Chongqing
* After birth, three injections of Hep B were inoculated in time according to the procedure of 0, 1 and 6 months(The vaccination certificate record)
* No HBV booster vaccine given since primary HBV immunization
* Children or guardian knew and agreed to accept the study
* Follow - up study and blood collection after vaccination can be accepted
Exclusion Criteria:
* Unwilling or impossible to participate in this research project;
* Have a history of allergy or have had a serious vaccine reaction
* Have immune impairment diseases and appear immune impairment;
* Immunosuppressive treatment, receive any injection or oral administration of cortisone or cancer chemotherapy;
* Any kind of vaccine or any kind of observation drug has been vaccinated in the past four weeks;
* Any acute disease or other infection requiring antibiotic or antiviral treatment in the past four weeks;
* Fever symptoms occurred in the past week ( axillary temperature ≥ 38 °C)
* Blood transfusion experience;
* Has a history of more serious infectious diseases ( five types of hepatitis, AIDS, syphilis, gonorrhea, etc. );
* Hepatitis B infection or carriers(lineal relationship);
* Abnormal physical examination
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
15 Years
Study:
NCT04439435
Study Brief:
Protocol Section:
NCT04439435