COVID-19 Reactogenicity

NCT ID: NCT07051031

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-06-30

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.

Conditions

Compare Post Vaccination Reactions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Novavax Vaccine

Protein-based vaccine

Group Type: EXPERIMENTAL

Nuvaxovid (NVX-CoV2705)

Intervention Type: DRUG

COVID-19 vaccination

Pfizer Vaccine

mRNA-based vaccine

Group Type: EXPERIMENTAL

Pfizer-BioNTech COVID-19 vaccine

Intervention Type: DRUG

COVID-19 vaccination

Interventions

Nuvaxovid (NVX-CoV2705)

COVID-19 vaccination

Intervention Type: DRUG

Pfizer-BioNTech COVID-19 vaccine

COVID-19 vaccination

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marcel Curlin

OTHER

Sponsor Role: lead

Responsible Party

Marcel Curlin

Medical Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Oregon Health and Sciences University

Portland, Oregon, United States

Countries

United States

Facility Contacts

Marcel E Curlin, MD

Role: primary

curlin@ohsu.edu

503-494-6633

Other Identifiers

VBA 501

Identifier Type: -

Identifier Source: org_study_id