A Study to Evaluate the Effectiveness and Safety of SCTV01E (a Recombinant Protein COVID-19 Vaccine) in Population Aged ≥12 Years
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the effectiveness of SCTV01E in participants aged ≥12 years.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
The study is a randomized, double-blind, positive-controlled Phase III study. It will evaluate the protective effectiveness and safety of SCTV01E against COVID-19 in participants who were previously unvaccinated with any COVID-19 vaccine (Cohort 1), or in participants who were previously fully vaccinated with Sinopharm inactivated COVID-19 vaccine (Cohort 2), or in participants who were previously fully vaccinated with mRNA/adenovirus vectored vaccine (Cohort 3).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Cohort 1: SCTV01E one dose of SCTV01E on D0, D28 and D180, respectively |
Biological: SCTV01E
D0; intramuscular injection
Biological: SCTV01E
D28; intramuscular injection
Biological: SCTV01E
D180; intramuscular injection
|
Active Comparator: Cohort 1: CoronaVac one dose of CoronaVac on D0, D28 and D180, respectively |
Biological: CoronaVac
D0; intramuscular injection
Biological: CoronaVac
D28; intramuscular injection
Biological: CoronaVac
D180; intramuscular injection
|
Experimental: Cohort 2: SCTV01E one dose of SCTV01E on D0 and D180, respectively |
Biological: SCTV01E
D0; intramuscular injection
Biological: SCTV01E
D180; intramuscular injection
|
Active Comparator: Cohort 2: Sinopharm inactivated COVID-19 vaccine one dose of Sinopharm inactivated COVID-19 vaccine on D0 and D180, respectively |
Biological: Sinopharm inactivated COVID-19 vaccine
D0; intramuscular injection
Biological: Sinopharm inactivated COVID-19 vaccine
D180; intramuscular injection
|
Experimental: Cohort 3: SCTV01E one dose of SCTV01E on D0 and D180, respectively |
Biological: SCTV01E
D0; intramuscular injection
Biological: SCTV01E
D180; intramuscular injection
|
Active Comparator: Cohort 3: Other approved vaccines the same COVID-19 vaccine the participant previously vaccinated or the locally approved COVID-19 vaccine on D0 and D180, respectively |
Biological: other approved COVID-19 vaccines
D0; intramuscular injection
Biological: other approved COVID-19 vaccines
D180; intramuscular injection
|
Outcome Measures
Primary Outcome Measures
- Stage 1: Cases of symptomatic COVID-19 of any severity in Cohort 2. [14 days after the 1st study vaccination]
Number of participants with symptomatic COVID-19 of any severity
- Stage 1: Cases of symptomatic COVID-19 of any severity in Cohort 1 (conditional: only if cases in Cohort 1 reach a pre-set threshold, in consideration of the high vaccination rate and challenges in recruiting participants). [14 days after the 1st study vaccination]
Number of participants with symptomatic COVID-19 of any severity
- Stage 2: Cases of symptomatic COVID-19 of any severity in Cohort 2. [7 days after the 2nd study vaccination]
Number of participants with symptomatic COVID-19 of any severity
- Stage 2: Cases of symptomatic COVID-19 of any severity in Cohort 1 (conditional: only if cases in Cohort 1 reach a pre-set threshold). [7 days after the 3rd study vaccination]
Number of participants with symptomatic COVID-19 of any severity
Secondary Outcome Measures
- Stage 1: Cases of symptomatic COVID-19 of any severity in the whole population. [14 days after the 1st study vaccination in Cohort 2 and Cohort 3 and 14 days after the 2nd study vaccination in Cohort 1]
Number of participants with symptomatic COVID-19 of any severity
- Stage 1: Cases of symptomatic COVID-19 of any severity in Cohort 2 and Cohort 3. [14 days after the 1st study vaccination]
Number of participants with symptomatic COVID-19 of any severity
- Stage 1: Cases of symptomatic COVID-19 of any severity in Cohort 3 (only if sufficient number of COVID-19 cases are collected in Cohort 3). [14 days after the 1st study vaccination]
Number of participants with symptomatic COVID-19 of any severity
- Stage 1: Incidence and severity of solicited AEs of SCTV01E from D0 to D7 in Cohort 2. [Day 0 to Day 7 after the 1st study vaccination]
- Stage 1: Incidence and severity of solicited AEs from D0 to D7, D28 to D35 in Cohort 1. [Day 0 to Day 7 after the 1st study vaccination, Day 28 to Day 35 after the 2nd study vaccination]
- Stage 1: Incidence and severity of solicited AEs of SCTV01E from D0 to D7 in Cohort 3. [Day 0 to Day 7 after the 1st study vaccination]
- Stage 1: Incidence and severity of SAEs and AESIs in stage 1. [Day 0 to Day 180 after the 1st study vaccination.]
- Stage 2: Cases of symptomatic COVID-19 of any severity in the whole population. [7 days after the 2nd study vaccination in Cohort 2 and Cohort 3, and 7 days after the 3rd study vaccination in Cohort 1.]
Number of participants with symptomatic COVID-19 of any severity
- Stage 2: Cases of symptomatic COVID-19 of any severity in Cohort 2 and Cohort 3. [7 days after the 2nd study vaccination]
Number of participants with symptomatic COVID-19 of any severity
- Stage 2: Cases of symptomatic COVID-19 of any severity in Cohort 3 (only if sufficient number of COVID-19 cases are collected in Cohort 3). [7 days after the 2nd study vaccination]
Number of participants with symptomatic COVID-19 of any severity
- Stage 2: Incidence and severity of solicited AEs of SCTV01E from D180 to D208 in Cohort 2. [Day 180 to Day 208 after the 2nd study vaccination]
- Stage 2: Incidence and severity of solicited AEs from D180 to D208 in Cohort 1. [Day 180 to Day 208 after the 3rd study vaccination]
- Stage 2: Incidence and severity of solicited AEs of SCTV01E from D180 to D208 in Cohort 3. [Day 180 to Day 208 after the 2nd study vaccination]
- Stage 2: Incidence and severity of SAEs and AESIs in stage 2. [After Day180 up to Day545]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female aged ≥12 years old (if the local regulatory authority didn't allow to enroll participants who were 12-15 years old, the participants should be ≥16 years old) when signing ICF;
-
For Cohort 1: Participants who were previously unvaccinated with any COVID-19 vaccine; For Cohort 2: Participants who were previously vaccinated with 2 or 3 doses of Sinopharm inactivated COVID-19 vaccine and the interval between the last dose and this study vaccination is ≥3 months and ≤12 months; For Cohort 3: Participants who were previously fully vaccinated with mRNA or adenovirus vectored COVID-19 vaccine (1-dose fully vaccinated or 2-dose fully vaccinated) and the interval between the last dose and this study vaccination is ≥3 months and ≤12 months;
-
The participant and/or his legal guardian and/or his entrusted person 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;
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The participant and/or his legal guardian and/or his entrusted person have the ability to read, understand, and fill in record cards;
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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:
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Previously diagnosed with COVID-19;
-
A positive result of nucleic acid test or rapid antigen test for SARS-CoV-2 during the screening period;
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A positive result of anti-SARS-CoV-2 IgG antibodies during the screening period for Cohort 1;
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Presence of fever within 3 days before the study vaccination;
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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.;
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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;
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Patients on antituberculosis therapy;
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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;
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Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
-
Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study;
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Participants who received other investigational drugs within 1 month before the study vaccination;
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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;
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Participants received other drugs or vaccines used to prevent COVID-19, but participants previously received Sinopharm inactivated COVID-19 vaccine, mRNA/adenovirus vectored COVID-19 vaccine will not be excluded;
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Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;
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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;
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Those who are pregnant or breast-feeding or plan to be pregnant during the study period;
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Those who plan to donate ovum or sperms during the study period;
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Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
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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;
-
Those who are tested positive for HIV in terms of serology.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sinocelltech Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCTV01E-MRCT-1