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| Column | Value |
|---|---|
| Trial registration number | NCT05433285 |
|
Full text link
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
2022-06-27 |
|
Recruitment status
Last imported at : Dec. 1, 2023, 8 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
inclusion criteria: clinically healthy subjects aged 18 years and above. subjects have been informed properly regarding the study and signed the informed consent form. subjects will commit to comply with the instructions of the investigator and the schedule of the trial. |
|
Exclusion criteria
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
subjects concomitantly enrolled or scheduled to be enrolled in another trial. history of vaccination with any covid-19 vaccine. history of covid-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment. evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). history of uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. history of blood disorders contraindicating intramuscular injection. patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.) which according to the investigator might interfere with the assessment of the trial objectives. history of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (> 2 weeks)). history of uncontrolled epilepsy or other progressive neurological disorders, such as guillain-barre syndrome. subjects receive any vaccination (other than covid-19 vaccine) within 1 month before and after ip immunization. subjects plan to move from the study area before the end of study period. |
|
Number of arms
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
PT Bio Farma |
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Inclusion age min
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Indonesia |
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Type of patients
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
4050 |
|
primary outcome
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Immunogenicity of the candidate vaccine;Seroconversion rate of the candidate vaccine |
|
Notes
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1154, "treatment_name": "Sars-cov-2 recombinant protein vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1159, "treatment_name": "Sars-cov-2 recombinant spike protein nanoparticle vaccine (sars-cov-2 rs)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |