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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01489956
Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Ability to give informed consent and comply with study procedures.
* Participant able/willing to hold off receiving prophylactic immunizations (like influenza or pneumococcal vaccines) during the study period.
Exclusion Criteria:
* Use of corticosteroids within 2 weeks prior to screening visit.
* First degree relative (parent, sibling or child) with history of autoimmune disease.
* Presence of chronic medical illness including but not limited to chronic kidney-, liver-, cardio-vascular diseases, immunodeficiencies, anemia, B12 deficiency, malignancies, or chronic active infections.
* History of acute gastrointestinal illness within 2 weeks prior to oral KLH administration.
* For women of child bearing age, participant unwilling to defer pregnancy, has a positive urine pregnancy test or is currently pregnant or lactating.
* Use of an investigational drug within 3 months of the screening visit.
* History of acute febrile illness within 1 week of screening visit.
* History of allergy to shellfish, previous exposure to KLH/product containing KLH or known-sensitivity to KLH / components of KLH preparation.
* Participants receiving any immunizations within 1 month prior to screening visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01489956
Study Brief:
Protocol Section:
NCT01489956