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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT00107705
Eligibility Criteria:
Inclusion Criteria:
* The subject must sign the study consent form prior to any screening procedures being performed.
* If the volunteer is female of childbearing potential, she must demonstrate a negative urine pregnancy test and agree to remain abstinent or use an effective method of birth control or use a hormonal contraceptive
* The subject must demonstrate a positive skin prick test to Birch, Hazel and Alder pollen allergen extract
* The subject must demonstrate a positive skin prick test to positive histamine control
* The subject must demonstrate a negative skin prick test to negative control
* The subject must demonstrate a specific IgE for Birch, Hazel and Alder as documented by a RAST (radioallergosorbent test), or equivalent test
* The subject must have clinically acceptable results from the screening procedure.
Exclusion Criteria:
* History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence or any other skin conditions which might interfere with the interpretation of skin prick test results
* Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick tests; both forearms must be available for testing
* Subject has asthma or other lower respiratory tract condition
* History or presence of diabetes, cancer or any clinically significant cardiac, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic or psychiatric diseases or disorders
* Any clinically significant abnormal laboratory value at Visit 1
* Clinically relevant sensitivity to any common perennial allergen: house dust mites, molds, epithelia (cat, dog, and horse), grass mix
* Clinically relevant symptoms due to an IgE - mediated allergy at screening and before inclusion to the treatment period.
* Secondary alteration at the affected organ.
* History of auto-immune diseases or rheumatoid diseases
* Subject has a medical condition that prohibits the use of adrenalin
* Subject has disorder of tyrosine metabolism
* Subject with diseases interfering with the immune response and have received medication, which could influence the results of this study
* Subject has acute or chronic infection
* History of anaphylaxis
* History of angioedema
* Subjects determined by the Investigator to have any medical condition that could jeopardize their health or prejudice the results
* History of hypersensitivity to the excipients of the study medication
* History of immunotherapy with tree allergen extracts
* Current therapy with ß-blockers
* Currently receiving anti-allergy medication or other drugs with antihistaminic activity
* Subject has a positive drugs of abuse screen at Visit 1
* Subject participated in a clinical trial with an investigational drug within the last 30 days
* Subject cannot communicate reliably with the Investigator or is deemed uncooperative or noncompliant
* Females who are pregnant, breastfeeding, or refuse to use a reliable method of birth control
* Subject received treatment with a preparation containing MPL during the past 12 months
* Use of prohibited medications or inadequate washout periods prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00107705
Study Brief:
Protocol Section:
NCT00107705