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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05279365 |
|
Full text link
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
s.rao@dhr-rgv.com |
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Registration date
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
2022-03-15 |
|
Recruitment status
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
Open 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 : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
inclusion criteria: adults 18 years and over that have been fully vaccinated (2 doses) with the pfizer/biontech covid-19 vaccine (bnt162b2) and withthe 1st booster atleast 90 days prior to the 2nd booster healthcare workers employed by and/or affiliated with dhr health, renaissance medical foundation, dhr partners, starr county memorial hospital any adult with any of the following risk factors for severe covid-19 disease progression (as outlined by the cdc) |
|
Exclusion criteria
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
previous history of allergic reaction to vaccination less than or equal to 3 months from last booster dose of vaccine active sars-cov-2 infection less than or equal to 21 days of full recovery from sars-cov-2 infection less than or equal to 14 days of any vaccination vaccinated with any other available covid-19 vaccine other than pfizer/biontech or moderna healthcare workers not employed by and/or affiliated with dhr health, renaissance medical foundation, star county memorial hospital or non dhr partners |
|
Number of arms
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
DHR Health Institute for Research and Development |
|
Inclusion age min
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
1000 |
|
primary outcome
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
Levels of anti-SARS-CoV-2 IgG antibody titers after booster;Number of participants infected with SARS-CoV-2 after booster Dose |
|
Notes
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine", "treatment_id": 1153, "treatment_name": "Sars-cov-2 mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |