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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT04864561
Eligibility Criteria:
Inclusion Criteria:
1. Participants must have read, understood, and signed the informed consent form (ICF).
2. Participants of either gender aged 12 years and older at screening.
3. Medically stable
4. Must be able to attend all visits of the study and comply with all study procedures,
5. Women of childbearing potential (WOCBP) must be able and willing to use at least 1 highly effective method of contraception for a minimum of 3 months after the last dose of study vaccine.
6. WOCBPs must have a negative pregnancy test prior to each vaccination.
Exclusion Criteria:
1. Participant is pregnant or planning to become pregnant within 3 months after study vaccine administration.
2. History of allergy to any component of the vaccine.
3. Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness, including fever \> 100 °F (\> 37.8 °C) 48 hours before vaccination.
4. Participant has a known or suspected defect of the immune system
5. Participant has a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
6. Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the participant may be enrolled. A history of hematologic malignancy is a permanent exclusion. Participants with a history of skin cancer must not be vaccinated at the previous tumour site.
7. History of drug dependency or current use of drug of abuse or alcohol abuse at screening.
8. Significant blood loss (\> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to the expected day of randomization (Visit 1).
9. History of clinically significant bleeding disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
10. Severe and uncontrolled ongoing autoimmune or inflammatory disease History of Guillain-Barre syndrome or any other demyelinating condition.
11. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer
Prior/concomitant therapy:
12. Receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study.
13. Receipt of medications and or vaccinations intended to prevent COVID-19.
14. Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (Visit 1).
15. Any member of the study team or sponsor.
16. An immediate family member or household member of the study's personnel.
Booster Vaccination (Adults and Adolescents)
In addition to the above-described eligibility criteria, the following criteria must be met:
1\. Participant has not received another licensed COVID-19 vaccine during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04864561
Study Brief:
Protocol Section:
NCT04864561