UnknownPhase 3

A Study to Evaluate the Efficacy and Safety of SCTV01E (a COVID-19 Vaccine) in Population Aged ≥18 Years

China10,000 participantsStarted 2022-12-26

Plain-language summary

The objective of this study is to evaluate the effectiveness of SCTV01E in participants aged ≥18 years.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female aged ≥18 years old when signing ICF;
✓. Participants who were fully vaccinated with COVID-19 vaccine and/or received booster vaccination, and the interval between the last dose of COVID-19 vaccine previously received and screening is 6 to 24 months;
✓. The participant and/or his/her legal 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/her legal 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 last dose of study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.

Exclusion criteria

✕. A positive result of nucleic acid test or rapid antigen test for SARS-CoV-2 during the screening period;
✕. Presence of fever within 3 days before the study vaccination;
✕. 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 six months prior to enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed;
✕. Patients on antituberculosis therapy;
✕. Presence of severe or uncontrollable cardiovascular diseases, or severe or uncontrollable disorders related to endocrine system, blood and lymphatic system, liver and kidney, respiratory system, metabolic and skeletal systems, or malignancies (skin basal cell carcinoma and carcinoma in-situ of cervix are exceptions and will not be excluded), such as severe heart failure, severe pulmonary heart disease, unstable angina, liver failure, or uremia;

What they're measuring

Cases of the first occurrence of symptomatic COVID-19 of any severity starting 7 days (≥8 days) after the study vaccination

Timeframe: 7 days after the study vaccination

Trial details

NCT IDNCT05308576

SponsorSinocelltech Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-10

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