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The purpose of this study is to compare post-vaccination reactions between the protein-based Novavax vaccine and the mNEXSPIKE mRNA-1283 vaccine. Specifically, the study aims to determine the rate of participant-reported symptoms associated with each type of vaccine.
Why is this study being conducted? Many individuals receive a flu vaccine each year, but fewer receive the COVID-19 booster, even though COVID-19 infection can be more severe. One possible reason is concern about vaccine side effects.
The goal of this study is to determine whether a different type of COVID-19 vaccine, called Novavax, causes fewer side effects than the more commonly used mRNA vaccines (such as Pfizer or Moderna) when administered as a seasonal booster.
What is Novavax? Novavax is a protein-based COVID-19 vaccine approved by the FDA. Earlier studies suggest that fewer side effects may occur with Novavax; however, not many studies have directly compared Novavax with mRNA vaccines
What is the purpose of this study? Eligible individuals who qualify for a COVID-19 booster are invited to participate. Participants will receive either the Novavax vaccine or an mRNA vaccine. After vaccination, participants will be asked to report any symptoms or side effects experienced. Collected information will help determine which vaccine may be better tolerated.
Why does this matter? By comparing participant experiences, this study aims to identify ways to improve acceptance and accessibility of COVID-19 booster vaccines. Findings may help increase public confidence in vaccination and support ongoing protection against COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novavax Vaccine | Experimental | Protein-based vaccine |
|
| mNEXSPIKE mRNA-1283 | Experimental | mRNA-based vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nuvaxovid (NVX-CoV2705) | Drug | COVID-19 vaccination |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting ≥1 Systemic Symptom Within 7 Days Post-Vaccination | Proportion and number of participants who report at least one systemic symptom (e.g., fever, fatigue, myalgia, headache, chills) within 7 days following COVID-19 booster vaccination, as collected via daily symptom diary. | within 7 days post vaccination |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Sciences University | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711928 | NVX-CoV2373 adjuvated lipid nanoparticle |
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| mNEXSPIKE mRNA-1283 |
| Drug |
COVID-19 vaccination |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |