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| Column | Value |
|---|---|
| Trial registration number | NCT05313035 |
|
Full text link
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
2022-04-06 |
|
Recruitment status
Last imported at : April 14, 2023, 8 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : April 7, 2022, 9:30 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 |
|
Study aim
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : April 7, 2022, 9:30 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 : April 7, 2022, 9:30 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, history of 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 received in the previous 4 weeks a treatment likely to alter the immuneresponse (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 : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
PT Bio Farma |
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Inclusion age min
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
Indonesia |
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Type of patients
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
360 |
|
primary outcome
Last imported at : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Immunogenicity of the candidate vaccine |
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Notes
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Bio Farma\nFormula 1", "treatment_id": 2170, "treatment_name": "Recombinant sars-cov-2 vaccine (rls)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Bio Farma\nFormula 2", "treatment_id": 2170, "treatment_name": "Recombinant sars-cov-2 vaccine (rls)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |