The objective of this study is to evaluate the effectiveness of SCTV01E in participantsaged ≥18 years.
The study is a randomized, double-blind, placebo-controlled Phase III study. It will
evaluate the protective effectiveness and safety of SCTV01E against COVID-19 in
participants who were previously received primary series or booster dose of COVID-19
vaccines.
Biological: SCTV01E
D0; intramuscular injection
Biological: Placebo
D0; intramuscular injection
Inclusion Criteria:
1. Male or female aged ≥18 years old when signing ICF;
2. 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;
3. 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;
4. The participant and/or his/her legal representative have the ability to read,
understand, and fill in record cards;
5. 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;
6. 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:
1. A positive result of nucleic acid test or rapid antigen test for SARS-CoV-2 during
the screening period;
2. Presence of fever within 3 days before the study vaccination;
3. A history of allergic reactions to any vaccine or drug, such as allergy, urticaria,
severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
4. A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
5. 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.;
6. 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;
7. Patients on antituberculosis therapy;
8. 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;
9. Contraindications for intramuscular injection or intravenous blood sampling,
including thrombocytopenia and other blood coagulation disorders;
10. Participants who received any immunoglobulin or blood products in the previous 3
months before enrollment, or plan to receive similar products during the study;
11. Participants who received other investigational drugs within 1 month before the
study vaccination;
12. Participants who is at the acute state of disease, such as acute onset of chronic
heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia,
acute renal insufficiency, acute cholecystitis;
13. Participants vaccinated with influenza vaccine within 14 days or with other vaccines
within 28 days before the study vaccination;
14. Those who donated blood or had blood loss (≥450 mL) within 3 months before the
vaccination or plan to donate blood during the study period;
15. Those who are pregnant or breast-feeding or plan to be pregnant during the study
period;
16. Those who plan to donate ovum or sperms during the study period;
17. Those who cannot follow the trial procedures, or cannot cooperate to complete the
study due to planned relocation or long-term outing;
18. Those unsuitable for participating in the clinical trial as determined by the
investigator because of other abnormalities that are likely to confuse the study
results, or non-conformance with the maximal benefits of the participants;
19. Those who are tested positive for HIV in terms of serology.
Guizhou center for disease control and prevention
Guiyang, Guizhou, China
Not Provided