PREVENT-19: A COVID-19 vaccine candidate clinical trial

Novavax initiated the PREVENT-19 trial to evaluate the safety, efficacy and immunogenicity of NVX-CoV2373, our vaccine candidate designed to provide protection against COVID-19 disease.

Trial ID:

2019nCov-301

Our Commitment Trial Details Eligibility Criteria What’s Involved FAQs

What’s involved in participating in this clinical trial

Participation in the PREVENT-19 trial is divided into three (3) periods

Screening

First, the study team will determine if you are eligible to take part in the study. Get started with this questionnaire.

Vaccine

If you are selected to participate, you will get two (2) injections of the investigational vaccine or placebo - one on the first day and a second again three (3) weeks (21 days) later.

Follow-up

The study team will monitor your health for two (2) years after the last injection.

You will be randomly assigned (by chance) to receive either the investigational vaccine or placebo. A placebo does not contain any actual medication. Neither you nor the study doctor will know which group you are in or which injections you receive. Each participant has a two (2) in three (3) chance of receiving the investigational vaccine and a one (1) in three (3) chance of receiving the placebo.

Locations

You will need to travel to one of our sites to take part in this clinical trial.
Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQ)

Can I get COVID-19 from the study vaccine being researched?

No. You cannot get infected with SARS-CoV-2 or get COVID-19 disease from the investigational vaccine.

Why is diversity important in this clinical trial?

Having a diverse patient population in clinical trials is important because medicines sometimes affect people differently based on age, gender and race. It has also been established that people from different backgrounds and in certain living situations are at even greater risk of getting sick from COVID-19.

PREVENT-19 aims to evaluate the vaccine in diverse populations to ensure that the vaccine is safe and effective for everyone.

Will there be compensation for participating in the clinical trial?

You may be compensated for participating in this clinical trial. We realize it takes time to travel to a site for study visits, so we want to make sure that your participation is not too much of a burden. The study site will review these details with you. Also, you do not have to pay to participate in the clinical trial. All study-related services are provided at no cost.

Does the study vaccine contain a live virus?

No. The vaccine candidate does not contain a live virus. NVX-CoV2373 contains a purified protein that cannot replicate and cannot cause COVID-19. This approach is similar to those used in vaccines available on the market today

What is a placebo?

In order to understand if the investigational vaccine works, medical researchers are comparing NVX-CoV2373 to a placebo made from water (saline). A placebo looks like the actual vaccine being tested but does not contain the vaccine’s active ingredients.

All clinical trial volunteers will receive the same level of quality care regardless of whether they are assigned to receive the study vaccine or the placebo.

What happens if I am diagnosed with COVID-19 while in this trial?

Each PREVENT-19 volunteer will be closely monitored by the study doctor and medical staff for symptoms of COVID-19 while in the clinical trial. If clinical trial participants are diagnosed with COVID-19 at any time during this trial, they should contact the study staff immediately for further instructions.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Why are clinical trials important??

Clinical trials determine the safety and effectiveness of new vaccines or treatments that are not yet approved by the Food and Drug Administration. A research plan or protocol is created that outlines how trial participants may receive interventions, which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo, or to no intervention at all. The PREVENT-19 study team will share specific details about this study with you before you participate.

Can I quit the trial at any time?

Clinical trial volunteers have the right to drop out of the clinical trial at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a clinical trial volunteer at any time for the participant’s safety, or if the participant no longer meets the requirements.

What personal information is collected about you for the clinical trial?

Your personal health information includes information obtained from your medical records, history, physical examinations or other procedures to determine your eligibility for the study and information that is created or collected from you during your participation in the study, including the results of various tests and procedures. The study personnel may see information that may identify you, such as: your address, telephone number, Social Security number, health plan number, year of birth, age, gender, race, ethnicity, or dates relating to various tests and procedures, or other identifying information. This information will be removed and replaced with your study number before your information leaves the study site. Your personal health information will be recorded in your medical records.

Who has access to your personal information?

Your medical records will remain at the study site and will be kept confidential. It may be necessary for the study doctor to disclose the records identifying you (including your original medical records) to authorized personnel of the sponsor, its agents, collaborators, research partners, assignees or designees (the “sponsor”), the Institutional Review Board of this study (the “IRB”), auditors, the U.S. Food and Drug Administration or other regulatory authorities (“Regulatory Authorities”), or other persons or entities as required by law. This disclosure, which will take place at the study site, may be required to verify that the study is conducted appropriately, and that the information collected for the study is correct and complete. If you share your personal data to contact a site, that data will be used by Citeline to contact you about clinical trials and related information.

What countries/territories and sites are approved to participate in this trial?

For a list of approved sites in your country/territory, please visit:

US FDA: Clinicaltrials.gov

Mexico: COFEPRIS

Are there COVID-19 vaccines currently available to me from the government?

Other COVID-19 vaccines have been granted Emergency Use Authorization (EUA) in the United States. Potential participants should clarify with the study investigator or their healthcare provider whether they are included in the groups recommended to receive the first vaccines under EUA, and how that may impact participation in the PREVENT-19 clinical trial.

This trial is not actively recruiting.

PREVENT-19: A COVID-19 vaccine candidate clinical trial

Novavax’ Commitment to Diversity & Inclusion

Prevent-19 At A Glance

Trial Details

Eligibility Criteria

What’s involved in participating in this clinical trial

Locations

Frequently Asked Questions (FAQ)

THANK YOU