Trials / Completed
CompletedNCT06680375
A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in Adults
A Phase 1/2, Randomized, Controlled Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Investigational Flu Seasonal/SARS-CoV-2 Combination mRNA Vaccine in Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
This study will evaluate the reactogenicity, safety, and immune response of Flu Seasonal/SARS-CoV-2 mRNA (mRNA Flu/COVID-19) combination vaccine. The flu portion will target multiple strains of the flu virus, while the COVID-19 part will focus on the spike protein of the SARS-CoV-2 virus. Both parts of this vaccine have been tested individually before. This will be the first study to test the combined vaccine in humans in healthy adult participants.
Detailed description
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Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Flu Seasonal /SARS-CoV-2 mRNA Dose 1 | A Flu mRNA vaccine composition in combination with Dose 1 of a COVID-19 component will be administered. |
| COMBINATION_PRODUCT | Flu Seasonal /SARS-CoV-2 mRNA Dose 2 | A Flu mRNA vaccine composition in combination with Dose 2 of a COVID-19 component will be administered. |
| COMBINATION_PRODUCT | Flu Seasonal mRNA | An investigational mRNA Flu Seasonal vaccine will be administered. |
| COMBINATION_PRODUCT | SARS-CoV-2 mRNA Dose 1 | Dose 1 of an investigational mRNA COVID-19 vaccine will be administered. |
| COMBINATION_PRODUCT | SARS-CoV-2 mRNA Dose 2 | Dose 2 of an investigational mRNA COVID-19 vaccine will be administered. |
| COMBINATION_PRODUCT | Licensed Flu Seasonal | A licensed Flu Seasonal vaccine will be administered. |
| COMBINATION_PRODUCT | Licensed COVID-19 mRNA | A licensed mRNA COVID-19 vaccine will be administered. |
| DRUG | Placebo | A placebo will be administered. |
Timeline
- Start date
- 2024-11-11
- Primary completion
- 2025-06-09
- Completion
- 2025-06-09
- First posted
- 2024-11-08
- Last updated
- 2025-09-11
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06680375. Inclusion in this directory is not an endorsement.