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| Column | Value |
|---|---|
| Trial registration number | NCT05453487 |
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Full text link
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
919987774@qq.com |
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Registration date
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
2022-07-12 |
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Recruitment status
Last imported at : July 30, 2022, 4 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
inclusion criteria: participants aged ≥18. have the ability to understand the study procedures, voluntarily sign informed consent. be able and willing to complete the entire study plan during the study follow-up period. participants have not received any rabies vaccine. participants have received 2 doses of inactivated covid-19 vaccine for 6-12 months. the time interval between the last vaccination is ≥14 days. body temperature < 37.3 °c confirmed by clinical examination before enrollment . exclusion criteria for the first dose: participants who have received the third dose of covid-19 vaccine. participants who have previously been infected with covid-19 or who have tested positive for sars-cov-2. having a history or family history of convulsions, epilepsy, encephalopathy and psychosis. being allergic to any component of vaccines and a history of severe allergic reactions to any vaccine. participants are suffering from immunodeficiency, receiving immunosuppressant therapy (oral steroid hormones) during treatment for malignancy, or having low immunity due to hiv within 14 days before enrollment, or having congenital immune disorders in close family members. injection of non-specific immunoglobulin within 1 month before enrollment. participants are suffering from acute febrile diseases and infectious diseases, or have used anti-inflammatory/antiviral/antipyretic/antiallergic drugs within 3 days before enrollment. a history of clearly diagnosed thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection. participants with severe chronic diseases or acute episodes of chronic diseases, hypertension or diabetes that cannot be controlled by drugs. participants with infectious, suppurative and allergic skin diseases. pregnant and lactating women. other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies. exclusion criteria for the second or third dose: subjects who had vaccine-related serious adverse reactions after vaccination. systemic adverse reactions/anaphylaxis with severity ≥3 after vaccination as determined by the investigator. participants experienced new conditions that met the "exclusion criteria for the first dose ". other reasons for exclusion considered by the investigator. |
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Exclusion criteria
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
None |
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Number of arms
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
China National Biotec Group Company Limited |
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Inclusion age min
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
360 |
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primary outcome
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
Neutralizing antibody GMC against rabies virus;Neutralizing antibody GMI against rabies virus;Neutralizing antibody GMI against SARS-CoV-2;Neutralizing antibody GMT against SARS-CoV-2;Seroconversion rate against rabies virus;Seroconversion rate against SARS-CoV-2 |
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Notes
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 2559, "treatment_name": "Bbibp-corv+rabies vaccine", "treatment_type": "Inactivated virus+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1054, "treatment_name": "Rabies vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}] |