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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT04780659
Eligibility Criteria:
Inclusion Criteria:
1\. Individuals ≥18 years old
2a. In the opinion of the investigator, individuals with immunosuppressive disease who meet one of the following criteria:
* Primary immunodeficiency
* Human immunodeficiency virus (HIV)-infection
* Allogeneic stem cell transplantation / Chimeric antigen receptor (CAR T cell) therapy
* Solid organ transplant
* Chronic lymphatic leukemia
or
2b. In the opinion of the investigator, individuals without immunosuppressive disease or treatment without significant co-morbidity
3\. Provision of signed informed consent to participate in the study
Exclusion Criteria:
1. Previous or ongoing Coronavirus Disease-19 (COVID-19).
2. Coagulation disorders, other conditions associated with prolonged bleeding time or anticoagulant treatments, which according to the investigator contraindicate intramuscular injection. Conditions which can be corrected with measures such as platelet concentrate treatments, coagulation factors or other measures for people responsible for anticoagulants are not exclusion criteria.
3. Planned to receive another vaccine within 14 days before the first dose of the study vaccine, or during the period from the first dose of the study vaccine up to 14 days after the second dose of the study vaccine, and vaccination with another vaccine which in the investigator's opinion cannot be planned outside these time periods
4. Pregnancy or breast feeding.
5. Hypersensitivity to the active substance or to any of the excipients contained in the vaccine
6. Individuals who cannot understand the informed consent.
7. Individuals who for other reasons are considered by investigators as not suitable for inclusion
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04780659
Study Brief:
Protocol Section:
NCT04780659