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 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT02266992
Eligibility Criteria:
Inclusion Criteria:
* Age18 - 49
* HIV1 infected
* On antiretroviral therapy
* CD4 count of \>200/mm3 (for at least 6 months, last available measurement within 3 months)
* Viral load undetectable (for at least 6 months, last available measurement within 3 months)
* Historyof having received at least one dose of trivalent inactivated influenza vaccine in the past
* Nonsmoker
Exclusion Criteria:
* Severe egg allergy
* Hypersensitivity to gentamicin
* Pregnant or breastfeeding
* Chronic lung disease (e.g. bronchiectasis)
* A history of severe asthma or current active wheezing
* Other cause for immunosuppression (e.g. malignancy) or immunosuppressive medication
* Hepatitis B or C coinfection (as defined by a detectable HBSAg or HCV RNA)
* Planned close contact with severely immunocompromised individuals in 2 weeks following LAIV (e.g bone marrow transplant recipients)
* Recipient of any other vaccination within the last 4 weeks
* Individuals who have had a febrile illness or other symptoms of acute infectious illness (respiratory, enteric or soft tissue) within the last 2 weeks.
* Individuals with a known and current history of anaemia or any symptoms (shortness of breath, chronic fatigue, chest pain or pallor) suggestive of possible anaemia or haemoglobin below the lower limit of sex adjusted normal range on a full blood count taken within the last 3 months.
* Current(active) participation in any clinical trial
* Inability to communicate in English or convey willingness to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT02266992
Study Brief:
Protocol Section:
NCT02266992