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Trial - NCT05933512


Column Value
Trial registration number NCT05933512
Full text link
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Xuxin Tian

Contact
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

xuxin_tian@sinocelltech.com

Registration date
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

2023-07-06

Recruitment status
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

inclusion criteria: 1. aged ≥3 years old when signing icf; 2. participants who were vaccinated with licenced covid-19 vaccines with recommended doses and immune schedule, and the interval between the last dose and icf is ≥6 months. 3. the participant and/or his/her legal guardians or entrusted person can sign the 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 guardians or entrusted person 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. 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 study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.

Exclusion criteria
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

1. presence of fever within 72 hours before the study vaccination (for participants >14 years old, axillary temperature ≥37.3℃; for participants ≤14 years old, axillary temperature ≥37.5℃;); 2. a positive result of antigen test or nucleic acid test for sars-cov-2 during the screening period; 3. a positive result of sars-cov-2 igm test; 4. known history of sars-cov-2 infection within 6 months before icf; 5. a history of sereve allergic reactions such as severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema, or allergic reactions to the study vaccines and its ingredient; 6. a medical or family history of seizure, epilepsy and psychosis; 7. 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; 8. contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders; 9. patients on antituberculosis therapy; 10. participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination; 11. participants who received other investigational drugs within 1 month before the study vaccination; 12. participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study; 13. 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; 14. those who are pregnant or breast-feeding or plan to be pregnant during the study period; 15. those who plan to donate ovum or sperms during the study period; 16. those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing; 17. 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.

Number of arms
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Sinocelltech Ltd.

Inclusion age min
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

3

Inclusion age max
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

600

primary outcome
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Geometric mean titers (GMT) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.;Seroresponse Rate (SRR) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.

Notes
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": " Group A", "treatment_id": 2164, "treatment_name": "Sctv01e", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": " Group A", "treatment_id": 2751, "treatment_name": "Sctv01e-2", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": " Group B", "treatment_id": 2751, "treatment_name": "Sctv01e-2", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]