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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT07078357
Eligibility Criteria:
Inclusion Criteria:
* • Healthy male or female volunteers, aged between 18 and 45 years;
* Availability to undergo all procedures throughout the study period;
* Provide free and informed consent to participate in the study.
Exclusion Criteria:
* Participation in clinical trials within the last year
* Participation in cohort studies
* Diagnosis of concomitant infections or diseases that may affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasms, and autoimmune diseases;
* Current or previous diagnosis or family history of ARF, chorea, obsessive-compulsive disorder, or glomerulonephritis;
* Current or previous diagnosis of heart diseases;
* Severe asthma or chronic obstructive pulmonary disease (COPD);
* Abnormal neurological clinical assessment, especially chorea;
* Use of treatments that may affect immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplastic agents;
* Use of treatments that may affect heart valves in the last four weeks or planned during the study period, including fenfluramine and dexfenfluramine;
* Renal insufficiency determined by estimated creatinine clearance below 45 ml/min/1.73m²;
* History of intolerance or allergy to any component of the study product, including antigen or adjuvant;
* Presence of valve abnormalities or alterations in cardiac anatomy as defined by echocardiogram;
* Altered electrocardiogram;
* Evidence or suspicion of recent S. pyogenes infection based on clinical symptoms in the last four weeks;
* Pregnancy, breastfeeding mother, or intention to become pregnant during the study period (only female participants);
* Any other condition that may interfere with the study process as assessed by the researchers, including sample size and statistical power.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07078357
Study Brief:
Protocol Section:
NCT07078357