A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in… (NCT05323461) | Clinical Trial Compass
UnknownPhase 3
A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines
United Arab Emirates1,800 participantsStarted 2022-05-30
Plain-language summary
The study is a randomized, double-blind, and positive-controlled Phase III booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with either one dose of Sinopharm inactivated COVID-19 vaccine (Cohort 1) or one dose of Comirnaty (Cohort 2).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female aged ≥18 years old when signing ICF;
✓. For Subgroup 1 in Cohort 1: Participants who were previously vaccinated with 2 or 3 doses of Sinopharm inactivated COVID-19 vaccine. The interval between the date of last dose and the date of this study vaccination should be 3 to 24 months.
✓. The participant and/or his legally acceptable representative can sign written ICF, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that can be selected if they do not participate in the trial;
✓. The participant and/or his legally acceptable representative have the ability to read, understand, and fill in record cards;
✓. Healthy participants or participants with pre-existing medical conditions who are in stable condition. The "pre-existing medical conditions" include but not limited to hypertension, diabetes, chronic cholecystitis and cholelithiasis, chronic gastritis that meet the described criteria. A stable medical condition is defined as disease not requiring significant change in therapy or no need for hospitalization as a consequence of worsening disease state for at least 3 months prior to enrollment;
✓. Fertile men and women of childbearing potential voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.
Exclusion criteria
✕. For Subgroup 1 in Cohort 1 only: Previously diagnosed with COVID-19.
✕. Presence of fever within 3 days before the study vaccination;
. A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or other disease corresponding use of immunosuppressants;
✕. A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
✕. A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
✕. Immunocompromised patients suffering from immunodeficiency diseases, important organ diseases, immune diseases (including Guillain-Barre Syndrome \[GBS\], systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy caused by any circumstances, and other immune diseases that may have an impact on immune response in the investigator's opinion), etc.;
✕. Long-term use of immunosuppressant therapy or immunomodulatory drugs for ≥14 days within the first six months prior to enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed;