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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT05078905
Eligibility Criteria:
* INCLUSION CRITERIA:
General Inclusion Criteria for All Groups:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Stated willingness to comply with all study procedures and availability for the duration of the study
2. Age 18 years or older
3. Hemoglobin \>= 9.0 grams per deciliter (g/dL) or \>= 11.2 for women who are pregnant.
4. Willingness to give consent for the storage of blood samples for research
5. Ability of subject to understand and the willingness to sign a written informed consent document
Inclusion Criteria for Primary (New) Vaccination Group:
1\. No history of having received a dose of the vaccine for the infectious disease being studied. Subjects who have enrolled under another Laboratory of Immunoregulation (LIR) protocol and had samples drawn prior to vaccination will also be eligible for enrollment.
Inclusion Criteria for Secondary (Booster) Vaccination Group:
1\. Willingness to return for baseline research blood collection prior to booster vaccination.
EXCLUSION CRITERIA:
1. Current abuse of alcohol or other drugs that, in the judgement of the Principal Investigator (PI) could interfere with patient compliance.
2. Any medical or mental health condition that, in the judgement of the PI, would make the volunteer unable to participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05078905
Study Brief:
Protocol Section:
NCT05078905