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| Column | Value |
|---|---|
| Trial registration number | NCT05907044 |
|
Full text link
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
|
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Contact
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
2023-06-18 |
|
Recruitment status
Last imported at : Jan. 26, 2024, 8 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
inclusion criteria: healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. participants 18 through 55 years of ages. participants who have received at least 3 doses covid-19 vaccine. participants with the last prior dose being 90 or more days before visit 1(day 0) or recovered from covid-19 at least 28 days. participants able to comply with all scheduled visits, laboratory tests and investigator's instruction. |
|
Exclusion criteria
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
women who are pregnant or breastfeeding. enrolling in or planning to participate other interventional clinical study. has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. continued using anticoagulants such as coumarin and related anticoagulants (i.e., warfarin) or oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran, and edoxaban). having coronary heart disease, hypertension, diabetes, chronic respiratory diseases, tumors and poorly controlled. immunocompromised or having immunosuppressive therapy. suspected or confirmed alcohol/drug dependence. investigator decide unsuitable factors for participating in clinical trials in the investigator's judgment |
|
Number of arms
Last imported at : June 28, 2023, 4 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Affiliated Hospital of Yunnan University |
|
Inclusion age min
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
55 |
|
Countries
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
China |
|
Type of patients
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Jan. 26, 2024, 8 a.m. Source : ClinicalTrials.gov |
376 |
|
primary outcome
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5;Number of Participants with Solicited Local and Systemic Averse Events(AEs) |
|
Notes
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : June 28, 2023, 4 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2500, "treatment_name": "Rq3013", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2735, "treatment_name": "Rq3025", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2746, "treatment_name": "Rq3027", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |