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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT06303635
Eligibility Criteria:
Inclusion Criteria:
1. Male or female.
2. Age from 18 to 65 years old, inclusive.
3. Complete primary vaccination for COVID-19 with one of the vaccines approved by ANVISA for use in Brazil, and at least one booster, the last of which must be with Comirnaty Bivalente BA.4/BA.5 between 4 and 18 months before vaccination. inclusion.
4. Body mass index (BMI) between 19.0 and 35.0 kg/m2, inclusive.
5. Female participant with a negative pregnancy test on the day of vaccination.
6. Consent form voluntarily signed before any procedure.
Exclusion Criteria:
1. Confirmation of active SARS-CoV-2 infection in rapid antigen test screening.
2. History of serious adverse reaction to any vaccine, medication or component of the investigational product.
3. History of immunodeficiency, autoimmune diseases and cardiomyopathies.
4. History of medium or major surgery within 3 months before inclusion.
5. History of malignancy within 1 year before screening (except basal cell carcinoma of the skin or in situ carcinoma of the cervix, which have already resolved).
6. History of uncontrolled coagulopathy or blood disorders that contraindicate intramuscular injection.
7. History of uncontrolled epilepsy or other progressive neurological disorders such as Guillain-Barré Syndrome.
8. Any decompensated chronic disease at the time of inclusion.
9. Treatment with immunosuppressive medications in the 3 months prior to the first vaccination or 6 months for chemotherapy.
10. History of systemic steroids (prednisone ≥ 20 mg/day or equivalent for \>14 consecutive days) within 3 months prior to screening. Topical, inhaled, intranasal, and intra-articular corticosteroids are permitted regardless of dose.
11. Use of any other vaccine less than 14 days before or planning to use up to 29 days after V0.
12. Use of blood products in the 3 months before inclusion.
13. Use of another investigational product within 1 year before inclusion.
14. Pregnancy or breastfeeding at inclusion or planned during the study.
15. Fever or any acute illness within 1 week before inclusion. Participants who do not meet this criterion may be rescheduled for a new inclusion visit.
16. Presence of tattoos, scars, skin discoloration or any other skin disorders at the injection site that, in the opinion of the investigator, may impair the assessment of local reactogenicity.
17. Any condition that, in the opinion of the investigator, endangers the safety or rights of the participant or makes the participant unsuitable for the study.
18. Clinically significant changes in safety examinations, defined as:
* Hb ≤ 10.9 g/dL;
* Leukocyte count \< 2500 cells/mm3;
* Absolute neutrophil count \< 1000 cells/mm3;
* ESR outside normal values (18 to 65 years old, male - 2 to 28 mm; 18 to 65 years old, female - 2 to 36 mm);
* ALT, AST and FA \> 1.25 x ULN;
* Total bilirubin \> 1.1 x ULN;
* Creatinine \> 1.1 x ULN;
* Glycated hemoglobin \> 5.6%;
* Troponin 1 \> 0.16 ng/mL;
* TP and aPTT \> 1.1 x ULN;
* CPK outside normal values (male adults - 38 to 174 U/L; female adults - 26 to 140 U/L);
* C-reactive protein \> 1.0 mg/dL.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06303635
Study Brief:
Protocol Section:
NCT06303635