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Trial - NCT04640402


Column Value
Trial registration number NCT04640402
Full text link
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04640402

First author
Last imported at : April 1, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : April 1, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Fengcai Zhu

Registration date
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-11-23

Recruitment status
Last imported at : April 1, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - aged 18 years and above. - able to understand the content of informed consent and willing to sign the informed consent. - able and willing to complete all the secluded study process during the whole study follow-up period (about 7 months). - axillary temperature ≤37.0℃. - general good health as established by medical history and physical examination.

Exclusion criteria
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

first dose

Number of arms
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

5

Funding
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Jiangsu Province Centers for Disease Control and Prevention

Inclusion age min
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

85

Countries
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

960

primary outcome
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Geometric mean (GMT) of specific antibody;The incidence of adverse reaction (AR)

Notes
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "20\u00b5g/0.5ml;2; 18-59 and 60-85 years old", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "20\u00b5g/0.5ml;3; 18-59 and 60-85 years old", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "40\u00b5g/1.0ml;2; 18-59 and 60-85 years old", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "40\u00b5g/1.0ml;3; 18-59 and 60-85 years old", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]