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| Column | Value |
|---|---|
| Trial registration number | NCT05163652 |
|
Full text link
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
yjs@imbcams.com.cn |
|
Registration date
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
2021-12-20 |
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Recruitment status
Last imported at : March 3, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : Dec. 22, 2021, 3 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 |
|
Study aim
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
inclusion criteria: axillary temperature ≤37.0 ℃. aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of coronavac or bbibp-corv, or one does coronavac and one does bbibp-corv. proven legal identity, could come each visit. participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form. |
|
Exclusion criteria
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
persons with a clear history of sars-cov-2 infection. using blood products after basic immunization or receiving immunosuppressive therapy. participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination. allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine); history of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors. diseases beyond drug control, such as high blood pressure, diabetes, asthma. those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days. immunization with any vaccine within 14 days. any other situations judged by investigators as not suitable for participating in this study. |
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Number of arms
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : Oct. 2, 2023, 10:07 a.m. Source : ClinicalTrials.gov |
Chinese Academy of Medical Sciences |
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Inclusion age min
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : March 3, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
432 |
|
primary outcome
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
Adverse reactions/events rate;Adverse reactions/events rate;SARS-CoV-2 specific memory B and T cell response;Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2 |
|
Notes
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Dec. 22, 2021, 3 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "third dose given after 3 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "third dose given after 4 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "third dose given after 5 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "third dose given after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |