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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT01980966
Eligibility Criteria:
Inclusion Criteria:
* In good health with no history of major medical conditions from medical history, physical examination and routine laboratory tests
* Male subjects and women of child-bearing potential must use effective contraception as defined by protocol, starting at entry to quarantine and continuing until Day 120 follow-up visit
* Sero-suitable for challenge virus
Exclusion Criteria:
* Women who have been pregnant within 6 months prior to the study, or who have been breastfeeding within 3 months prior to the study, or who have a positive pregnancy test at any point in the study
* Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the CI
* Abnormal pulmonary function evidenced by clinically significant abnormalities in spirometry
* History of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung disease of any etiology. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment.
* History suggestive of respiratory infection within 14 days prior to admission to the unit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01980966
Study Brief:
Protocol Section:
NCT01980966