A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years
NCT ID: NCT05308602
Last Updated: 2024-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2022-04-01
2023-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine
NCT05239806
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine SCTV01E-1 in Population Aged Above 18 Years
NCT05522829
A Study to Evaluate the Efficacy and Safety of SCTV01E (a COVID-19 Vaccine) in Population Aged ≥18 Years
NCT05308576
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine in Population Aged ≥18 Years
NCT05329051
A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine
NCT05652543
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SCTV01C
SCTV01C
Day 0; intramuscular injection
SCTV01C
Day 28; intramuscular injection
SCTV01C
Day 180; intramuscular injection
SCTV01E
SCTV01E
Day 0; intramuscular injection
SCTV01E
Day 28; intramuscular injection
SCTV01E
Day 180; intramuscular injection
mRNA vaccine manufactured by Pfizer or Moderna
mRNA vaccine manufactured by Pfizer or Moderna
Day 0; intramuscular injection
mRNA vaccine manufactured by Pfizer or Moderna
Day 28; intramuscular injection
mRNA vaccine manufactured by Pfizer or Moderna
Day 180; intramuscular injection
Sinopharm inactivated COVID-19 vaccine
Sinopharm inactivated COVID-19 vaccine
Day 0; intramuscular injection
Sinopharm inactivated COVID-19 vaccine
Day 28; intramuscular injection
Sinopharm inactivated COVID-19 vaccine
Day 180; intramuscular injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SCTV01C
Day 0; intramuscular injection
SCTV01C
Day 28; intramuscular injection
SCTV01C
Day 180; intramuscular injection
SCTV01E
Day 0; intramuscular injection
SCTV01E
Day 28; intramuscular injection
SCTV01E
Day 180; intramuscular injection
mRNA vaccine manufactured by Pfizer or Moderna
Day 0; intramuscular injection
mRNA vaccine manufactured by Pfizer or Moderna
Day 28; intramuscular injection
mRNA vaccine manufactured by Pfizer or Moderna
Day 180; intramuscular injection
Sinopharm inactivated COVID-19 vaccine
Day 0; intramuscular injection
Sinopharm inactivated COVID-19 vaccine
Day 28; intramuscular injection
Sinopharm inactivated COVID-19 vaccine
Day 180; intramuscular injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participants who were neither vaccinated with any COVID-19 vaccine (including COVID-19 vaccine or vaccine adjuvant in clinical trial) nor diagnosed with COVID-19;
3. Participants or his/her legal guardian (or entrusted person) can sign written ICF and voluntarily participate in the trial, 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. Participant him/herself or with the assistance of his/her family member is capable of finishing the 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 age 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 age are negative on screening.
Exclusion Criteria
2. A positive result of IgG antibody against the SARS-CoV-2 virus during the screen period;
3. A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or corresponding immunosuppressants;
4. A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
5. A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
6. 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.;
7. Long-term use of immunosuppressant therapy or immunomodulatory drugs for ≥14 days within the 1st six months prior to enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed.
8. Patients on antituberculosis therapy;
9. 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 (exception for skin basal cell carcinoma and carcinoma in-situ of cervix) , such as severe heart failure, severe pulmonary heart disease, unstable angina, liver failure, or uremia;
10. Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
11. Participants who received any immunoglobulin or blood products in the previous 3 months, or plan to receive similar products during the study;
12. Participants who received other investigational drugs within 1 month before the study vaccination;
13. 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;
14. Participants received other drugs used for prevention of COVID-19;
15. Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;
16. 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;
17. Those who are pregnant or breast-feeding or plan to be pregnant during the study period;
18. Those who plan to donate ovum or sperms during the study period;
19. Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
20. 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;
21. Those who are tested positive for HIV in terms of serology.
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sinocelltech Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SCTV01C/E-02-In-Laos-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.