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| Column | Value |
|---|---|
| Trial registration number | NCT05401448 |
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Full text link
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
clayson.gomes@faculdadepm.edu.br |
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Registration date
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
2022-06-02 |
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Recruitment status
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 3, 2022, 2 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 : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
inclusion criteria: to be eligible to participate in this study, the participant must meet the following criteria: • be older than 18 years old. observation: the elderly is at risk for severe forms of covid-19, therefore, the evidence in this age group is very relevant. however, they can also be a first priority population to receive a specific vaccine, limiting the time to follow-up on the study. in addition, influenza and mmr vaccines can lead to a lower immune system in the elderly than in young people. therefore, it is likely that a more rational choice will be to carry out the study in a young population. |
|
Exclusion criteria
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
participants will not be included in the study if they present (reported by the research participants): known allergy to components of influenza and mmr vaccines or serious adverse events to previous administration. fever (> 38 degrees celsius) in the last 24 hours. pregnancy. note: pregnancy should be avoided for one month after vaccination. symptoms of active viral or bacterial infection. documented diagnosis of covid-19. vaccination in the last 4 weeks against sars-cov-2. immunocompromised participants. this exclusion category includes: a) infection with the human immunodeficiency virus (hiv-1); b) neutropenic participant with less than 500 neutrophils/mm3; c) participant with organ transplantation; d) participants with bone marrow transplantation; e) participants in chemotherapy treatment; f) participants with primary immunodeficiency; g) participants with severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine medication; i) treatment with oral or intravenous steroids, for example, daily doses of prednisone or equivalent for more than 3 months, or probable use of oral or intravenous steroids within next four weeks. some type of lymphoma or malignancy in the previous two years. direct involvement in the design or execution of the study. absence from work for more than 4 weeks within the next 12 weeks after study admission (vacation, maternity leave, retirement, planned surgery, etc.) |
|
Number of arms
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Radboud University Medical Center |
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Inclusion age min
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Brazil |
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Type of patients
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
2000 |
|
primary outcome
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Cumulative incidence of SARS-CoV-2 infection;Cumulative incidence of SARS-CoV-2 infection;Cumulative incidence of SARS-CoV-2 infection during 1 year follow up |
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Notes
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Phase 1 |
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Arms
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 2414, "treatment_name": "Influenza vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 774, "treatment_name": "Measles mumps rubella vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |