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 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT04579250
Eligibility Criteria:
INCLUSION CRITERIA:
1. Healthy adults between the ages of 18-70 years (excluding adults born between January 1, 1965 and December 31,1970)
2. Based on history and examination, in good general health and without history of any of the conditions listed in the exclusion criteria
3. Received at least one licensed influenza vaccine from 2015 to the present
4. Able and willing to complete the informed consent process
5. Available for clinic visits for 40 weeks after enrollment
6. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
7. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days before enrollment
Laboratory Criteria within 56 days before enrollment
8. White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval
9. Total lymphocyte count greater than or equal to 800 cells/microL
10. Platelets = 125,000 - 500,000 cells/microL
11. Hemoglobin within institutional normal range or accompanied by the PI or designee approval
12. Serum iron within institutional normal range or accompanied by the site PI or designee approval
13. Serum ferritin within institutional normal range or accompanied by the site PI or designee approval
14. Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN)
15. Aspartate aminotransferase (AST) less than or equal to 1.25 x institutional ULN
16. Alkaline phosphatase (ALP) \<1.1 x institutional ULN
17. Total bilirubin within institutional normal range, except when otherwise consistent with Gilbert's syndrome
18. Serum creatinine less than or equal to 1.1 x institutional ULN
19. Negative for HIV infection by an FDA-approved method of detection
Criteria applicable to women of childbearing potential:
20. Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) on the day of enrollment
21. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study
EXCLUSION CRITERIA:
1. Breast-feeding or planning to become pregnant during the study
Individual has received any of the following substances:
2. More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
3. Blood products within 16 weeks prior to enrollment
4. Live attenuated vaccines within 4 weeks prior to enrollment
5. Inactivated vaccines within 2 weeks prior to enrollment
6. Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
7. Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
8. Current anti-TB (tuberculosis) prophylaxis or therapy
9. Previous investigational H10 influenza vaccine
10. Receipt of a licensed influenza vaccine within 6 weeks prior to enrollment
Individual has a history of any of the following clinically significant conditions:
11. Serious reactions to vaccines that preclude receipt of the study vaccination as determined by the investigator
12. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
13. Asthma that is not well controlled
14. Diabetes mellitus (type I or II), with the exception of gestational diabetes
15. Thyroid disease that is not well controlled
16. Idiopathic urticaria within the past year
17. Autoimmune disease or immunodeficiency
18. Hypertension that is not well controlled (baseline systolic \> 140 mmHg or diastolic \> 90 mmHg)
19. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
20. Malignancy that is active or history of malignancy that is likely to recur during the period of the study
21. Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years
22. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
23. Guillain-Barre Syndrome
24. Previous or current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) documented by polymerase chain reaction (PCR) test
25. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
INCLUSION OF VULNERABLE PARTICIPANTS
Children
Children were not eligible to participate in this clinical trial because the investigational vaccine had not been previously evaluated in adults. If the product is assessed as safe and immunogenic, other protocols designed for children may be conducted in the future.
NIH Employees
NIH employees and members of their immediate families could have participated in this protocol. If eligible, the Guidelines for the Inclusion of Employees in NIH Research Studies were followed for employees and each employee was given a copy of the 'NIH Information Sheet on Employee Research Participation' and a copy of the 'Leave Policy for NIH Employees Participating in NIH Medical Research Studies.'
Neither participation nor refusal to participate had an effect, either beneficial or adverse, on the participant's employment or work situation. The NIH information sheet regarding NIH employee research participation was distributed to all potential participants who are NIH employees. The employee participant's privacy and confidentiality was preserved in accordance with NIH Clinical Center and NIAID policies. For NIH employee participants, consent was obtained by an individual who is independent of the participant's team. If the individual obtaining consent is a co-worker to the participant, independent monitoring of the consent process will be included through the Bioethics Consultation Service. Protocol study staff were trained on obtaining potentially sensitive and private information from co-workers or subordinates.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04579250
Study Brief:
Protocol Section:
NCT04579250