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Trial - NCT05012800


Column Value
Trial registration number NCT05012800
Full text link
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05012800

First author
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Yun-Bo Xie, MD

Contact
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

15110140963@163.com

Registration date
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

2021-08-19

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

Unknown

Study design
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

nonRCT

Allocation
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Non-randomized

Design
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - a covid-19 vaccine is planned. - older adults subjects aged 60-80 years or young adults subjects aged 18-59 years. - able and willing to follow the requirements of the clinical trial protocol and complete the study follow-up for 12 months. - hbsag, anti-hcv, hiv and tpha were negative. - body temperature ≤37.0℃.

Exclusion criteria
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

- people who are allergic to any component of the vaccine, or have a serious history of vaccine allergy. - women who is pregnant, breastfeeding, or planning to be pregnant within 6 months. - sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs. - patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. - patients with congenital or acquired angioedema / neuroedema. - patients with lymphoma, leukemia and other systemic malignancies. - patients with convulsions, epilepsy, encephalopathy, psychiatric disorders and other progressive neurological disorders, or a family history of them. - patients with acute attack of chronic diseases. - during vaccination, immunomodulators, systemic cytotoxic drugs, immune checkpoint inhibitors (pd-1 / pdl-1 / ctla-4, etc.) and cell therapy, including nk cells, cytokine induced killer cells, dendritic cells, ctl and stem cells infusion are required. - other conditions determined by the researcher.

Number of arms
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Beijing 302 Hospital

Inclusion age min
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

300

primary outcome
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Immunogenicity of coronavirus vaccine;Safety of coronavirus vaccine

Notes
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Healthy people between the ages of 60 and 80 inoculated coronavirus vaccine on day 0 and day 21, respectively.", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Healthy people between the ages of 20 and 59 inoculated coronavirus vaccine on day 0 and day 21, respectively.", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]