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| Column | Value |
|---|---|
| Trial registration number | NCT04952727 |
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Full text link
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Aug. 17, 2022, 7 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Aug. 17, 2022, 7 p.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
2021-07-07 |
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Recruitment status
Last imported at : Aug. 17, 2022, 7 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Blind 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 : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: health subjects aged 60 and above, who have been completed two-dose regimen of inactive sars-cov-2 vaccine in the past 3-6 months, or received one dose of inactive sars-cov-2 vaccine in the past 1-3 months. 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. axillary temperature ≤ 37.0#. individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.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, pregnant or breast-feeding, or have a pregnancy plan within six months. have acute febrile diseases and infectious diseases. have severe chronic diseases or condition in progress cannot be controlled. congenital or acquired angioedema / neuroedema have the history of urticaria 1 year before receiving the investigational vaccine. have asplenia or functional asplenia. have thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection). have needle sickness. have the history of immunosuppressive therapy, anti-allergy therapy,cytotoxic therapy or inhaled corticosteroids (excluding corticosteroidspray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months. have received blood products within 4 months before injection of investigational vaccines. under anti-tuberculosis treatment. not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to variousmedical, psychological, social or other conditions. |
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Number of arms
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Jiangsu Province Centers for Disease Control and Prevention |
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Inclusion age min
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
60 |
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Inclusion age max
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
300 |
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primary outcome
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.;Incidence of adverse reactions within 28 days after the booster dose. |
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Notes
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "5\u00d710^10;2+1;booster of recombinant SARS-CoV-2 Ad5 vectored vaccine after 3~6 months (primed with two doses of inactive SARS-CoV-2 vaccine)", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5\u00d710^10;1+1;one dose of recombinant SARS-CoV-2 Ad5 vectored vaccine after 1~3 months (primed with one dose of inactive SARS-CoV-2 vaccine)", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "600 SU;2+1;booster of inactive SARS-CoV-2 vaccine after 3~6 months (primed with two doses of inactive SARS-CoV-2 vaccine)", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "600 SU;1+1; one dose of inactive SARS-CoV-2 vaccine after 1~3 months (primed with one dose of inactive SARS-CoV-2 vaccine)", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |