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Trial - ChiCTR2100045109


Column Value
Trial registration number ChiCTR2100045109
Full text link
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Sui Peng

Contact
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

pengsui@vip.163.com

Registration date
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-04-07

Recruitment status
Last imported at : May 20, 2021, 7:59 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Center
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Prevention

Inclusion criteria
Last imported at : Nov. 12, 2021, 5:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Aged 18-59 years.

Exclusion criteria
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Those who 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. Those with fever or those who suffer from acute diseases or severe chronic diseases in the acute stage of onset, 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. Those who have been diagnosed with congenital or acquired immunodeficiency HIV infected lymphoma leukemia or other autoimmune diseases, 6. Those who have severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases and 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. Those who are considered unsuitable for vaccination by clinicians.

Number of arms
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : May 20, 2021, 7:59 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

The First Affiliated Hospital; Sun Yat-Sen University

Inclusion age min
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

59

Countries
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

China

Type of patients
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Healthy volunteers

Severity scale
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

472

primary outcome
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

SARS-CoV-2 RBD specific antibody level;

Notes
Last imported at : April 14, 2021, 2:05 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 : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : April 14, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "Vaccinated in the morning;2", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Vaccinated in the afternoon;2", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]