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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT06289868
Eligibility Criteria:
Inclusion Criteria:
Subject inclusion criteria for the signs and symptoms (S/S), at risk (A/R), HAV test ordered, and Acute HAV Infection cohorts:
* Subjects ≥ 2 years of age
* Subject or legal guardian has signed the Informed Consent Form (ICF) (a minor may need to sign an Assent Form (AF) if required by IRB)
* Subjects who are willing to donate the required amount of blood
* Subjects qualified for one (1) or more of the following four (4) Cohorts:
* Signs and symptoms (S/S);
* At risk (A/R);
* Presumed S/S or A/R (HAV test ordered) and
* Acute HAV Infection (known anti-HAV IgM positive samples) - these samples are not subject to the individual informed consent and volume criteria.
Subject inclusion criteria for the vaccination cohort
* Subjects 2 years of age or older
* Subjects able to understand and willing to sign the ICF at both pre and post vaccination time points. Subject or legal guardian has signed the Informed Consent Form (a minor may need to sign an assent form if required by IRB)
* Subjects who are willing to donate the required amount of blood: 30 mL
* Subjects with no signs or symptoms of hepatitis as determined by a medical provider, no history of known exposure to HAV
* Subjects previously unvaccinated for HAV
Exclusion Criteria:
* Subjects who previously participated in the study
* Subjects who have received experimental or investigational drugs or treatments within four weeks of phlebotomy
Note for vaccination study: Subjects were screened for anti-HAV prior to vaccination, if positive they were excluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT06289868
Study Brief:
Protocol Section:
NCT06289868