| Trial registration number
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ChiCTR2100049467 |
Full text link
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.chictr.org.cn/showproj.aspx?proj=129377
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First author
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Peizeng Yang
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Contact
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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peizengycmu@126.com
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Registration date
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-08-02
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Recruitment status
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Center
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : April 21, 2022, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Age >= 18 years old,
2. Not vaccinated before screening,
3. Diagnosed with any form of uveitis in any eye,
4. Inactive disease state (all of the following are met):
(1)<=0.5+ anterior chamber cells,
(2)<=0.5+ vitreous opacity,
(3) No active inflammatory choroidal or retinal vascular disease.
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Exclusion criteria
Last imported at : April 21, 2022, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. Complete remission of uveitis: no active disease 3 months after discontinuation of all ophthalmic treatment,
2. Any known contraindications to the vaccine provided according to the manufacturing instructions:
(1) Individuals with a history of hypersensitivity to any vaccine component,
(2) Individuals whose body temperature exceeds 38.5 degree,
(3) Pregnancy.
3. Any other situation that, in the opinion of the investigator, would put the subject at risk due to participation in this study.
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Number of arms
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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The First Affiliated Hospital of Chongqing Medical University
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Inclusion age min
Last imported at : April 21, 2022, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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China
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Type of patients
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1314
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primary outcome
Last imported at : April 21, 2022, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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time to worsening uveitis;
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Notes
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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Arms
Last imported at : April 21, 2022, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "prompt", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "deferred", "treatment_id": 340, "treatment_name": "Covid19 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]
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