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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT02445703
Eligibility Criteria:
Inclusion Criteria:
* Healthy infants between 18 and 24 months old;
* Have not received hepatitis A vaccine before;
* Completed hepatitis B vaccine full immunization schedule;
* Written consent of the guardian of each participant;
Exclusion Criteria of the First Injection:
* History of allergy to vaccine(s), or history of serious adverse reaction to vaccination, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain;
* Autoimmune disease or immunodeficiency;
* Any acute disease that made the conditions of the person unsuitable for vaccination
* Administration of any live attenuated vaccine within 14 days prior to the injection;
* Administration of any subunit vaccine or inactivated vaccine within 7 days prior to the injection;
* Administration of treatment of immunosuppressants (e.g., corticosteroid) within 1 month prior to the injection, or planning for such treatment during this study;
* Body temperature \> 37.0 °C before injection;
* Based on the evaluation of the investigator, there was any other factor that indicating the person was unsuitable for this study;
Exclusion Criteria of the Second Injection:
* Any acute infectious disease, body temperature \> 38.5 °C or acute attacks of chronic diseases within 3 days prior to the second injection;
* Administration of blood product or other investigational drug during this study;
* Occurrence of adverse event at grade 3 or higher and the event was related to the first injection;
* The investigator or the Ethic Committee decided that the subject should be excluded;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
24 Months
Study:
NCT02445703
Study Brief:
Protocol Section:
NCT02445703