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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT05208060
Eligibility Criteria:
Inclusion Criteria:
* Subjects that have provided written informed consent.
* Healthy males and females 18 to 65 years, both included, at the time of enrolment.
* Subjects who are able to provide cooperation and comply with dosing regimen.
* Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of enrolment in the trial.
Exclusion Criteria:
* Simultaneous participation in another clinical trial.
* Females who are pregnant or breast-feeding, or potential pregnant or breast-feeding females.
* Subjects who are allergic to any of the components included in MV130.
* Subjects with any concomitant disease or treatment that, according to the investigator criteria, may affect the development of this study, such as immunodeficiencies, malignancies involving bone marrow or lymphoid systems, medical treatment affecting the immune system (including corticosteroids, immunosuppressants, biological agents,…), human immunodeficiency virus, severe allergies, diabetes, hypertension, psychological disorders, etc.
* Subjects who have been vaccinated within 12 months before inclusion (flu or any other vaccine different from COVID-19 vaccine), or who have planned to be vaccinated during the clinical study (excluding the COVID-19 vaccine).
* Subjects who have had an infection that included fever and/or diarrhoea within 3 months before inclusion.
* Subjects under metformin treatment during the last month before inclusion in the clinical study or during the clinical trial\*.
* Subjects under statins treatment during the last month before inclusion in the clinical trial or during\*.
\*: these drugs interfere with metabolic pathways involved in trained immunity induction.
* Subjects who are allergic to any of the components included in the flu vaccine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05208060
Study Brief:
Protocol Section:
NCT05208060