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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 180
Awards & highlights
Study Summary
This trial tests Novavax vaccines as booster doses after a series of mRNA vaccine doses to see if they are safe and effective.
Who is the study for?
Adults aged 18-49 who previously received mRNA COVID-19 vaccines and a Novavax booster at least 180 days ago. Must be in good health, not pregnant or planning pregnancy, agree to use contraception if of childbearing potential, and not participate in other SARS-CoV-2 trials.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Novavax's NVX-CoV2373 vaccine as a booster following initial mRNA COVID-19 vaccinations. Participants will receive either the ancestral strain or an alternative/multivalent version with Matrix-M adjuvant.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions like soreness at injection site, fatigue, headache, muscle pain, possible allergic reactions but specifics will depend on individual responses to the Novavax vaccine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neutralizing Antibody (Nab) responses expressed as Geometric Mean Titers
Secondary outcome measures
Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as Seroresponse (SPR)
Incidence and Relationship of Serious Adverse Events (SAEs)
Incidence and Severity of Adverse Events Special Interests (AESIs)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Updated COVID-19 VaccineExperimental Treatment1 Intervention
1dose of updated COVID-19 vaccine on Day 1
Group II: NVX CoV2373 (Ancestral strain)Experimental Treatment1 Intervention
1dose of NVX-COV2373 on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NVX-CoV2373
2022
Completed Phase 3
~1690
SARS-CoV-2 rS antigen/Matrix-M Adjuvant
2023
Completed Phase 3
~300
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Who is running the clinical trial?
NovavaxLead Sponsor
46 Previous Clinical Trials
106,264 Total Patients Enrolled
17 Trials studying COVID-19
71,095 Patients Enrolled for COVID-19
Clinical DevelopmentStudy DirectorNovavax, Inc.
34 Previous Clinical Trials
88,344 Total Patients Enrolled
15 Trials studying COVID-19
65,897 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a previous episode of heart inflammation or swelling.You have received an extra COVID-19 vaccine booster after getting the first dose of NVX-CoV2373 during Study 307.You had a confirmed case of COVID-19 in the past 4 months.You have received certain medications that weaken the immune system in the last 90 days, except for rabies treatment if needed.You have received the NVX-CoV2373 COVID-19 vaccine at least 180 days before participating in this study.Adults aged 18 to 49 who have received two or three doses of mRNA COVID-19 vaccine before getting one dose of the NVX-CoV2373 vaccine.You have been receiving strong cancer treatment within the last year that might weaken your immune system.You have a condition or are taking medication that weakens your immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Updated COVID-19 Vaccine
- Group 2: NVX CoV2373 (Ancestral strain)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial accommodate those aged 80 and above?
"To be eligible for this investigation, the patient must belong in the 18 to 49 age bracket. There are 129 separate clinical trials specifically targeting minors and 767 dedicated to senior citizens."
Answered by AI
Has the NVX CoV2373 (Ancestral strain) been conclusively authorized for public use by the FDA?
"This Phase 3 trial has yielded extensive data on NVX CoV2373 (Ancestral strain)'s safety, resulting in a score of 3."
Answered by AI
In what areas is this research endeavor being conducted?
"Presently, this medical study is enrolling from 5 different clinics. These include Fort Worth, Plano and San Antonio amongst a few other spots. To limit travel demands for potential participants, it's important to select the closest clinic available in your area."
Answered by AI
Am I eligible to take part in this medical study?
"To be eligible for this covid-19 trial, prospective participants must have contracted the virus and fall between 18 and 49 years old. This research initiative aims to enrol 300 patients in total."
Answered by AI
Is this research initiative currently recruiting participants?
"As of now, this clinical trial is not presently seeking enrolment. This activity was initiated on March 28th 2023 and last updated on May 16th 2023. Nevertheless, there are 884 other studies that are actively recruiting patients at the present time."
Answered by AI
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