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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT05303402
Eligibility Criteria:
Inclusion Criteria:
* Male, female or transgender, ≥ 18 years old at Day 0.
* Provide inform consent form
* Participant who has:
* 3 doses of mRNA vaccines
* 2 doses of mRNA vaccines and previous COVID-19 infection
* 2 doses of Coronavac and 1 Comirnaty, or, 1 Coronavac and 2 Comirnaty
* Participant who has:
* HIV infection with CD4 Tcells counts \<400
* Primary antibody deficiency disorders
* Kidney disease on dialysis
* Kidney transplant at least \>1 year
* Auto Immune Disease (AID) in treatment with rituximab
* For a female of childbearing potential, to have a negative pregnancy test at Day 0
* Use of any of these contraception:
* Female: hormonal contraception, intrauterine device, vasectomized partner, sexual abstinence, condom.
* Male: Vasectomized participant, sexual abstinence, condom.
Exclusion Criteria:
* History of anaphylaxis to any prior vaccine
* Participants has received or plans to receive live attenuated vaccines, other not live vaccines, or Vaxzevria or Janssen vaccines.
* Pregnant or breast-feeding at Day 0.
* A confirmed COVID-19 diagnose \<90 days prior to vaccination day 0.
* A clinically significant acute illness or fever at screening or 48h before day 0.
* Participant had a surgery requiring hospitalisation and has not received the hospital discharge.
* Participant has an ongoing severe and non-stable psychiatric condition
* Participant has a problematic or risky use of substances including alcohol
* Participant has a bleeding disorder that contraindicates intramuscular injection
* Participant suffering from post-acute COVID-19 syndrome / long COVID
* Participant received any immunotherapy to prevent/treat COVID-19 in the last 90 days
* Participant is already participating in another research involving drug, biologics or device
* Participant has donated ≥450 ml of blood products within 12 weeks before screening
* Participant has any medical condition and/or finding that in the investigator opinion might increase participant risk, interfere with the study or impair interpretation of study data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05303402
Study Brief:
Protocol Section:
NCT05303402