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| Column | Value |
|---|---|
| Trial registration number | NCT05499351 |
|
Full text link
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
2022-08-12 |
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Recruitment status
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: healthy adults aged 18 years and above; have been received two doses of inactivated sars-cov-2 vaccine(coronavac)manufactured by sinovac research & development co., ltd at an interval of 6 months or more; participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ; proven legal identity; |
|
Exclusion criteria
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
history of sars-cov-2 infection; have been received two doses of inactivated sars-cov-2 vaccine(coronavac)manufactured by sinovac research & development co., ltd at an interval of less than 6 months; have received received any circulating seasonal influenza vaccine; have received any pneumococcal vaccine within 5 years; history of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; history of uncontrolled epilepsy and other serious neurological diseases such as transverse myelitis, guillain-barre syndrome, demyelinating diseases; history of fever at the time of vaccination, or acute onset of chronic disease, or severe uncontrolled chronic disease, or acute disease; already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months; receipt of other investigational drugs in the past 30 days; receipt of attenuated live vaccines in the past 14 days; receipt of inactivated or subunit vaccines in the past 7 days; according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial. |
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Number of arms
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Sinovac Biotech Co., Ltd |
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Inclusion age min
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
3000 |
|
primary outcome
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Immunogenicity index of seroconversion rate of the neutralizing antibody |
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Notes
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : Aug. 13, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Adult group in immunogenicity and safety study", "treatment_id": 2587, "treatment_name": "Covid19 vaccine+influenza vaccine+pneumococcal vaccine", "treatment_type": "Protein subunit+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Elderly group in immunogenicity and safety study", "treatment_id": 2587, "treatment_name": "Covid19 vaccine+influenza vaccine+pneumococcal vaccine", "treatment_type": "Protein subunit+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Adult group in safety observation study", "treatment_id": 2587, "treatment_name": "Covid19 vaccine+influenza vaccine+pneumococcal vaccine", "treatment_type": "Protein subunit+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Elderly group in safety observation study", "treatment_id": 2587, "treatment_name": "Covid19 vaccine+influenza vaccine+pneumococcal vaccine", "treatment_type": "Protein subunit+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}] |