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 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT05580159
Eligibility Criteria:
Inclusion Criteria:
1. Participant is willing and able to give written informed consent for participation in the study.
2. Male or Female, aged 18 years or above and in good health as determined by study clinician.
3. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunization continuously until 3 months after boost immunization.
4. In the Investigator's opinion, is able and willing to comply with all trial requirements.
5. Subjects had completed the 2-dose series vaccination of COVID-19 inactivated vaccine at least .
24 weeks with the completed the 2-dose Series as the primary vaccination according to the product label.
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
1. Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
2. Self-reported history of SARS and MERS infection;
3. Receipt of live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination;
4. Receipt of any SARS-COV-2 vaccine after last dose of primary vaccination
5. Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination.
6. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
7. History of allergic disease or reactions likely to be exacerbated by any component of study vaccines.
8. Any history of anaphylaxis to any component of vaccine.
9. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or continuous use of anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban), or prior history of significant bleeding or bruising following IM injections or venipuncture.
10. Suspected or known current alcohol or drug dependency
11. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
12. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness (mild/moderate well controlled comorbidities are allowed).
13. Scheduled elective surgery during the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05580159
Study Brief:
Protocol Section:
NCT05580159