v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT05855408 |
|
Full text link
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
|
|
First author
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
jingxin42102209@126.com |
|
Registration date
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
2023-05-11 |
|
Recruitment status
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
Adaptive |
|
Masking
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
inclusion criteria: adults aged 18 years and over, including the elderly over 60 years and those with underlying diseases. volunteers are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form. ≥ 4 months from the last sars-cov-2 infection (or never been infected), and 6 months or more from the first booster immunization of the covid-19 vaccine. |
|
Exclusion criteria
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
volunteers have suspected symptoms of covid-19 when enrolled, such as dry throat, sore throat, cough, etc. the covid-19 antigen quick test kit is positive when volunteers are enrolled. fever, temperature > 37.0°c. have received a second covid-19 vaccine booster immunization. have a history of serious adverse reactions related to the vaccine and/or have a history of severe allergic reactions to any component of the investigational vaccine (only applicable to the vaccine groups). pregnant or lactating women. hiv infection, tuberculosis, low immunity caused by disease or long-term medication. acute disease or acute onset of chronic disease. epilepsy and other progressive neurological disorders. other situations that are not suitable for participating in this research, according to the judgment of the researcher. |
|
Number of arms
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
5 |
|
Funding
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
Jiangsu Province Centers for Disease Control and Prevention |
|
Inclusion age min
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
China |
|
Type of patients
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
10000 |
|
primary outcome
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
The incidence of COVID-19 from 14 days to 6 months after the booster immunization. |
|
Notes
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
[{"arm_notes": "Aerosolized", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 394, "treatment_name": "Delns1-2019-ncov-rbd-opt1", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Intramuscular", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2449, "treatment_name": "Sys6006", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Blank control", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |