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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT01695733
Eligibility Criteria:
Inclusion Criteria:
* Patients must have biopsy-confirmed non-hematological malignancy
* Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic setting), excluding immunotherapy
* Patients must be of age \>=18 years.
* Patients must have an absolute lymphocyte count \>= 1,000/mcL immediately prior to influenza vaccination
* Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients who have already received the influenza vaccine during the season in which they are considered for eligibility will be excluded
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the influenza vaccine or egg allergies
* Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza vaccination
* Patients must not be receiving chronic steroid therapy, defined as \>= 14 days, unless used as part of a chemotherapy regimen
* Patients must not be on any other agents that can suppress the immune system
* Planned concurrent therapy with radiation
* Uncontrolled illness at time of enrollment or influenza vaccination including, but not limited to, ongoing or active febrile illness
* Psychiatric illness/social situations that would limit compliance with study requirements
* Known immunosuppression eg. history of organ transplantation or known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because they may not be able to mount an appropriate immune response
* History of influenza-like illness, defined as a temperature \> 37.8 degree C with cough or sore throat starting October 1, 2011 throughout the duration of the study
* Patient may not be scheduled to receive chemotherapy on a weekly basis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01695733
Study Brief:
Protocol Section:
NCT01695733