COVID-19 Reactogenicity
Purpose
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.
Condition
- Compare Post Vaccination Reactions
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Novavax Vaccine |
Protein-based vaccine |
|
|
Experimental Pfizer Vaccine |
mRNA-based vaccine |
|
Recruiting Locations
More Details
- NCT ID
- NCT07051031
- Status
- Not yet recruiting
- Sponsor
- Marcel Curlin
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.