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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05254236 |
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Full text link
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Aug. 12, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Aug. 12, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
2022-02-24 |
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Recruitment status
Last imported at : Sept. 24, 2023, midnight Source : ClinicalTrials.gov |
Withdrawn |
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Study design
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Feb. 25, 2022, 7 p.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 : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
inclusion criteria: healthy adults aged 18 years and above, who have received two prior doses of mrna covid-19 vaccine (comirnaty®, made by biontech/pfizer) as the primary vaccination, with the second dose given at least 180 days prior to the day of booster vaccination in the present study; evidence of a deep throat saliva (dts) pcr negative for sars-cov-2 within 24 hours before enrollment; female participants who have a negative pregnancy test on the day of vaccination, and not currently breastfeeding; the participants are able to understand and sign the informed consent voluntarily; the participants are willing and able to comply with all schedule visits, sample collection,vaccine plan, and other study procedures; the participants must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study. |
|
Exclusion criteria
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
history of confirmed or having evidence showing a current infection of sars-cov-2 prior to randomization; any prior administration of another investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19; known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema; serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc.; acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders; receipt of blood/plasma products or immunoglobulins in the past three months before vaccination in this study; participation in other studies involving study intervention within 30 days prior to vaccination in this study; receipt of attenuated live vaccines in the past fourteen days prior to vaccination in this study; receipt of inactivated or subunit vaccines in the past seven days prior to vaccination in this study; acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma,migraine, gastrointestinal disorder, etc.); acute febrile illness with oral temperature >37.5c on the day of vaccination; according to the investigator's judgment, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk to the participant due to participation in the study. |
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Number of arms
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
Sinovac Research and Development Co., Ltd. |
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Inclusion age min
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Sept. 24, 2023, midnight Source : ClinicalTrials.gov |
0 |
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primary outcome
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
Immunogenicity index-Geometric mean fold rise (GMFR) of neutralization antibody titre in the high dose;Immunogenicity index-Geometric mean fold rise (GMFR) of neutralization antibody titre in the medium dose |
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Notes
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Medium-dose", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High-dose", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |