COVID-19 Reactogenicity

Marcel Curlin

Status and phase

Not yet enrolling

Phase 4

Conditions

Compare Post Vaccination Reactions

Treatments

Drug: Nuvaxovid (NVX-CoV2705)

Drug: Pfizer-BioNTech COVID-19 vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT07051031

VBA 501

Details and patient eligibility

About

The purpose of this study is to compare post-vaccination reactions between the protein-based Novavax vaccine and the mRNA Pfizer vaccine. Specifically, the study aims to determine the rate of participant-reported symptoms associated with each type of vaccine.

Full description

Why are we doing this study? Many people get a flu shot each year, but not as many get the COVID-19 booster, even though COVID-19 can be more serious. One reason might be that some people are worried about side effects from the vaccine.

We want to learn whether a different kind of COVID-19 vaccine, called Novavax, causes fewer side effects than the more commonly used mRNA vaccines (like Pfizer or Moderna) when given as a seasonal booster.

What is Novavax? Novavax is a protein-based COVID-19 vaccine that has been approved by the FDA. Earlier studies suggest that people may have fewer side effects with Novavax, but not many studies have directly compared it to mRNA vaccines

What is the purpose of this study? We are inviting you to join this study because you are eligible to receive a COVID-19 booster. If you choose to participate, you will receive either the Novavax vaccine or an mRNA vaccine. After your shot, we'll ask you how you feel. This helps us learn which vaccine may be easier on the body.

Why does this matter? By comparing experiences from different people, we hope to find ways to make COVID-19 boosters more acceptable and accessible. This could help more people feel confident about getting vaccinated and staying protected.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adults eligible for seasonal COVID-19 vaccine, ages 18 and older Signed informed consent form (ICF) and agree to participate in the study Prior receipt of one or more COVID-19 vaccines

Exclusion criteria

If a person is experiencing a moderate or severe illness or infection (as judged by the study investigator) or has a fever (temperature of 38.0°C or higher) on the day they are supposed to participate in the study, they should not join until they are feeling better and the fever is gone.
Anyone with a medical or mental health issue, or problems with substance use that might make taking part in the study risky
People who have had a severe allergic reaction to COVID-19 vaccines in the past
Those who have been diagnosed with inflammation in or around the heart after receiving a COVID-19 vaccine
Individuals who have received any other vaccine within a week before joining the study or who plan to get a vaccine on the same day as the study or within 7 days afterward