COVID-19 Reactogenicity
- Conditions
- Compare Post Vaccination Reactions
- Interventions
- Drug: Nuvaxovid (NVX-CoV2705)
- Registration Number
- NCT07051031
- Lead Sponsor
- Marcel Curlin
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Novavax Vaccine Nuvaxovid (NVX-CoV2705) Protein-based vaccine Pfizer Vaccine Pfizer-BioNTech COVID-19 vaccine mRNA-based vaccine
- Primary Outcome Measures
Name Time Method Reactogenicity within 7 days post vaccination
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States
Oregon Health and Sciences University🇺🇸Portland, Oregon, United States