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:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT05972733
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects aged 18 to 49 years, inclusive.
* Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
* The individual signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements.
* Individuals willing and able to comply with trial procedures and are available for the duration of follow-up.
Exclusion Criteria:
* Females who are pregnant or breastfeeding.
* Gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration).
* Known hypersensitivity or allergy to any of the HIL-214 components (including excipients).
* Known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
* Any serious chronic or progressive disease (including hepatitis B or C).
* Previous exposure to an experimental norovirus vaccine.
* Subject or subject's first-degree relatives are involved in the trial conduct.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT05972733
Study Brief:
Protocol Section:
NCT05972733