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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults ≥ 18 years of age at screening who, by virtue of age, race, ethnicity or life circumstances, are considered at substantial risk of exposure to and infection with SARS CoV-2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 360 to day 750
Awards & highlights
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.
Who is the study for?
Adults and adolescents (12+) at high risk for COVID-19 exposure can join this trial. They must have completed the NVX-CoV2373 vaccine series, agree not to join other SARS-CoV-2 trials, be medically stable, and use contraception if of childbearing potential. Exclusions include prior COVID-19 diagnosis, recent or planned vaccines, significant immunosuppression conditions or treatments, pregnancy/breastfeeding intentions within 3 months post-vaccination.Check my eligibility
What is being tested?
The study tests the efficacy and safety of a COVID-19 vaccine with Matrix-M1 adjuvant in adults/adolescents. It includes initial vaccination, booster doses, and evaluates immune response. Participants are randomly assigned to receive either the vaccine or placebo during different periods of the study.See study design
What are the potential side effects?
Possible side effects may include typical reactions like soreness at injection site, fatigue, headache; allergic responses to ingredients; immune system-related symptoms; or more serious events that will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 360 to day 750
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 360 to day 750
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adult Main Study and Pediatric Expansion: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)
Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points
Pediatric Expansion: Deaths Due to Any Cause
+9 moreSecondary outcome measures
Adult Main Study : Deaths Due to Any Cause
Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point
Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points
+26 moreOther outcome measures
Booster Amendment: Deaths Due to Any Cause
Booster Amendment: Description of course, treatment and severity of COVID-19
Booster Amendment: Incidence and severity of MAAE's, SAE's and AESI's
+21 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster)Experimental Treatment1 Intervention
One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 Second Booster Vaccination Period.
Group II: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial vaccination)Experimental Treatment1 Intervention
2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21 in Initial Vaccination Period.
Group III: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination)Experimental Treatment1 Intervention
One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 or Day 21 in Crossover Vaccination Period.
Group IV: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)Experimental Treatment1 Intervention
One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 Booster Vaccination Period.
Group V: Placebo (Initial Vaccination)Placebo Group1 Intervention
2 doses of Placebo (Saline), 1 dose each on Days 0 and 21in Initial Vaccination Period.
Group VI: Placebo (Crossover Vaccination)Placebo Group1 Intervention
One dose of Placebo (Saline) on Day 0 or Day 21 in Crossover Vaccination Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
2020
Completed Phase 3
~33000
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster Vaccination)
2020
Completed Phase 3
~33000
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)
2020
Completed Phase 3
~33000
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
2020
Completed Phase 3
~33000
Find a Location
Who is running the clinical trial?
NovavaxLead Sponsor
46 Previous Clinical Trials
73,564 Total Patients Enrolled
Department of Health and Human ServicesFED
226 Previous Clinical Trials
895,949 Total Patients Enrolled
Lisa M Dunkle, MDStudy DirectorNovavax, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
- Group 2: Placebo (Initial Vaccination)
- Group 3: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover 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)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Coronavirus Patient Testimony for trial: Trial Name: NCT04611802 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Florida
California
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Alabama Clinical Therapeutics, Llc (Pediatric Site)
Accel Research Sites (Adult Site)
Anaheim Clinical Trials (Adult Site)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0
What questions have other patients asked about this trial?
Is this Novavax the updated one for omicron subvariant?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
To help out with finding new medicines. I'm interested in contributing to the study.
PatientReceived 1 prior treatment
I am a retired RN with a MPH and strongly support preventive measures at disease.
PatientReceived 1 prior treatment
The opportunity to be a part of a research that could help find a cure and get paid for it.
PatientReceived 2+ prior treatments
I suffered from a pulmonary embolism that required an ER visit in July 2019 and have scaring in my lungs. I take Elliquis for my episode.
PatientReceived no prior treatments
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