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Trial - ChiCTR2100048665


Column Value
Trial registration number ChiCTR2100048665
Full text link
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Sui Peng

Contact
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

pengsui@vip.163.com

Registration date
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-07-12

Recruitment status
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

nonRCT

Allocation
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Non-randomized

Design
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Single group assignment

Masking
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Center
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Prevention

Inclusion criteria
Last imported at : March 29, 2022, 12:06 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1.Aged 18 to 59 years, 2.Participants who had finished two dose of inactivated vaccine against Novel Coronavirus of Beijing biological vaccine.

Exclusion criteria
Last imported at : March 29, 2022, 12:06 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1.Patients are allergic to any component of the vaccine, and those who have history of severe allergic reactions to the vaccine, such as acute allergic reactions, urticaria, skin eczema, dyspnea, angioedema or abdominal pain, 2.Patients with fever, acute disease, severe chronic disease or acute onset of chronic disease, 3.Pregnant women, lactating women, or having a pregnancy plan within 3 months, 4.Patients with a history or family history of convulsions, epilepsy, encephalopathy or mental illness, Patients with uncontrolled epilepsy and other progressive neurological diseases, Patients with a history of Guillain-Barré syndrome, 5.Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune disease, 6.Known or suspected suffering from serious respiratory diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, 7.A history of COVID-19 infection, 8.Patients who take medicine affecting the immune function, such as immunosuppressant agents or immunopotentiators or glucocorticoids (>=10mg prednisone or other equivalent glucocorticoids) within one month before enrollment, 9.Patients are considered unsuitable for vaccination by clinicians.

Number of arms
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1

Funding
Last imported at : March 29, 2022, 12:06 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

the First Affiliated Hospital; Sun Yat-sen University

Inclusion age min
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

59

Countries
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

China

Type of patients
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Healthy volunteers

Severity scale
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

63

primary outcome
Last imported at : March 29, 2022, 12:06 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Novel Coronavirus receptor binding domain specific antibody levels;

Notes
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 0

Arms
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "Third dose;2 groups (morning vs afternoon)", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]