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Study Summary
This trial is testing a new vaccine for adults and adolescents. It will compare the new vaccine to a placebo vaccine to see if it is effective, safe, and causes an immune response. There will also be a substudy to test a fourth dose of the new vaccine in adults who have already received three doses.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You are allergic to any ingredient in the experimental drug.You have any medical condition that may harm you or affect the accuracy of the study's results.You cannot participate if you are currently enrolled in another clinical trial for preventing COVID-19.You cannot participate in any other trial to prevent COVID-19 while you are in this study.Children ages 12 to under 18 who are in good health or have stable medical conditions can participate in the study. The doctor will review their health status, medical history, and do a physical exam before the study. Their vital signs, like body temperature and weight, must be normal before the first vaccine.You can only participate in the Booster Amendment if you have received a full dose of the SARS-CoV-2 rS vaccine with Matrix-M1 adjuvant, or any other authorized/approved COVID-19 vaccine. You need to show proof of vaccination at the booster visit.You have a weakened immune system that could cause significant health problems.You have participated in another research study where you were given an experimental treatment within 45 days before the first vaccination in this study.You and your parent(s)/caregiver(s) or legally acceptable representative understand the study and agree to participate in it. You will follow the study's procedures.You cannot participate in any other COVID-19 prevention trial while you are in this study.You understand the study and agree to participate by giving your consent and following the study procedures.If you are a female and can have children, you must not have sex for at least 28 days before joining the trial and for 3 months after the last vaccination OR use a medically approved form of birth control consistently during this period.You are in good health as determined by the doctor and have normal vital signs like body temperature and weight.If you are a woman who could become pregnant and have not had your uterus, fallopian tubes, or ovaries removed, you must agree to avoid sexual activity or use a reliable form of birth control for at least 3 months after the study vaccination.You are 18 years or older and have a higher chance of being exposed to and infected with SARS CoV-2 due to your age, race, ethnicity, or life circumstances.You have an ongoing serious health condition that is not well-controlled.
- Group 1: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination)
- Group 2: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
- Group 3: Placebo (Initial Vaccination)
- Group 4: Placebo (Crossover Vaccination)
- Group 5: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial vaccination)
- Group 6: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Where are the various testing sites for this trial located?
"There are 100 different sites where this trial is taking place. While some are in Bardstown, Baltimore and Las Vegas, there are many other options which can be found on the website. It might be easiest to choose a location that is close to your home to limit travel."
Is this a controlled or open-label trial?
"The clinical trial mentioned is not recruiting patients at this moment, as per the information found on clinicaltrials.gov. This particular study was posted on December 27th, 2020 and updated for the last time on August 2nd, 2022. Although this particular trial isn't looking for patients, there are 1,152 other clinical trials that are."
What prior research exists on SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)?
"The SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination) was first trialed in 2011 at the Drug Research Center. So far, 13 have completed. Out of the 10 active studies, a considerable amount are being conducted out of Bardstown, Kentucky."
What are the central aims of this clinical trial?
"The main objective of this trial is to assess the safety and efficacy of the study vaccine in children and adults over a 375-day period. Secondary objectives include measuring the antibody response to the SARS-CoV-2 rS protein receptor binding epitope in adults and children, assessing the incidence and severity of adverse events of special interest in adults, and measuring the number of deaths due to any cause in the study population."
What are the risks associated with SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)?
"Although Phase 3, there is both efficacy and safety data supporting SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination), making it a safe 3."
What is the study's patient capacity?
"This study is no longer enrolling patients. The original posting was on December 27th, 2020 and the last update was on August 2nd, 2022. If you are seeking other studies, there are 1142 clinical trials for covid-19 and 10 trials for SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination) that are still recruiting patients."
Have there been similar medical studies to this one before?
"At the moment, there are 10 ongoing clinical trials for SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination) in 9 different countries and 136 cities. The first trial began in 2011 and, after completing Phase 1 drug approval, involved 110 patients. In the years since 2011, a total of 13 trials have been completed."
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