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| Column | Value |
|---|---|
| Trial registration number | NCT05204589 |
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Full text link
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : May 19, 2022, 8:39 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : May 19, 2022, 8:39 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
2022-01-24 |
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Recruitment status
Last imported at : May 19, 2022, 8:39 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
inclusion criteria: health subjects aged ≥18 years. have received two-dose inactivated sars-cov-2 vaccine before 6 months or more. the subject can provide with informed consent and sign informed consent form (icf). the subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study. |
|
Exclusion criteria
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis. be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination. women with positive urine pregnancy test. have acute febrile diseases and infectious diseases. axillary temperature>37.0℃. have serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥180mmhg and/or diastolic blood pressure ≥110mmhg when measured in the field). have severe chronic diseases or condition in progress cannot be smoothly controlled, such as asthma, diabetes, thyroid disease. congenital or acquired angioedema / neuroedema. have the history of urticaria 1 year before receiving the investigational vaccine. have asplenia or functional asplenia. patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities. have history of sars-cov-2 infection or covid-19. have symptoms of upper respiratory tract infection. have traveled to medium or high risk areas or traveled abroad in the past 21 days, and epidemiologically contacted with sars-cov-2. any medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's informed consent. |
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Number of arms
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
Jiangsu Province Centers for Disease Control and Prevention |
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Inclusion age min
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
10420 |
|
primary outcome
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.;Incidence of adverse reactions within 28 days after the booster dose. |
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Notes
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : March 27, 2022, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": " safety cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "immunogenicity cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "immunogenicity cohort will receive one homologous booster dose of ICV", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |