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 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT05272735
Eligibility Criteria:
Inclusion Criteria:
* Males and females
* Age 18-50 years Note: The HBV vaccine dose will be adjusted according to the Package Insert for participants who are 18 and 19 years of age.
* No prior history of HBV infection or vaccination.
Exclusion Criteria:
* HBV seropositivity (e.g. HBsAb, HBcAb or HBeAb)
* HIV infection
* Chronic HCV infection
* Pregnancy or lactation
* History of allergic reaction to any components of the HBV vaccine
* History of significant local or systemic reactogenicity to vaccines (eg, anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration)
* Any clinically relevant abnormality on history or examination, including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted), immunosuppressive, anticancer, antituberculosis or other medications considered significant by the Investigator within the previous 6 months; Note: The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on Investigator clinical judgment) at least 2 weeks prior to enrollment in this study
* Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the volunteer unsuitable for participation in the study
* Bleeding disorder that was diagnosed by a physician (eg, factor deficiency, coagulopathy or platelet disorder that requires special precautions)
* Laboratory abnormalities:
Platelets \<125,000 cells/mm3 PT/INR \>1.3 PTT \> 2 x ULN
* Receipt of live attenuated or mRNA vaccine within the previous 30 days or planned receipt within 30 days after IP administration; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after IP administration
* Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05272735
Study Brief:
Protocol Section:
NCT05272735