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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07399132
Eligibility Criteria:
Inclusion Criteria:
* Age Part A: Age ≥18 years and ≤54 years Part B: Age ≥55 years
* Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion Criteria:
* History of severe allergic or anaphylactic reactions of any type
* Acutely ill or febrile (temperature ≥38.0°C/100.4°F) 72 hours prior to or at the Day 1 visit
* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric or neurological disease/disorder within the past 3 months, or any acute minor illness (e.g. common cold, influenza, minor infection) within the past 1 month, determined by the PI (or delegate) to be clinically relevant
* Reported history of congenital or acquired immunodeficiency
* Dermatologic conditions that could affect local solicited AR assessments
* Coagulopathy or a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
* Diagnosis of a malignancy within previous 5 years
* Has received systemic immunosuppressants for \>14 days in total within 180 days prior to the Randomization Visit
* Has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the final study injection
* Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (eg, infliximab), or blood products within 90 days prior to the Randomization Visit or plans to receive them during the study
* Female participant with positive pregnancy test or Lactating females
* Has positive serology tests result (HIV, HCV and HBsAg) at screening visit
* Has positive drugs of abuse test results at screening visit
* Has participated in an interventional clinical study within 3 months prior to the Randomization Visit or plans to do so while participating in this study
* Has donated ≥450 mL of blood products within 28 days prior to the Randomization Visit or plans to donate blood products during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07399132
Study Brief:
Protocol Section:
NCT07399132