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COMPLETED Phase 1

A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in Adults

NCT06680375 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • COMBINATION_PRODUCT Flu Seasonal /SARS-CoV-2 mRNA Dose 1
  • COMBINATION_PRODUCT Flu Seasonal /SARS-CoV-2 mRNA Dose 2
  • COMBINATION_PRODUCT Flu Seasonal mRNA
  • COMBINATION_PRODUCT SARS-CoV-2 mRNA Dose 1
  • COMBINATION_PRODUCT SARS-CoV-2 mRNA Dose 2

Study Locations (9)

Florida

  • GSK Investigational Site — Hialeah
  • GSK Investigational Site — Miami
  • GSK Investigational Site — Miami

Alabama

  • GSK Investigational Site — Anniston

California

  • GSK Investigational Site — Rolling Hills Estates

Kansas

  • GSK Investigational Site — Lenexa

Missouri

  • GSK Investigational Site — St Louis

Nebraska

  • GSK Investigational Site — Omaha

New York

  • GSK Investigational Site — Rochester

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2024-11-11
Est. Completion 2025-06-09
Phase Phase 1

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06680375

The ClinicalTrials.gov registry entry for NCT06680375 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 5 interventions — of which Flu Seasonal /SARS-CoV-2 mRNA Dose 1 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06680375 reports 9 study locations spanning 7 distinct geographic areas — top geographies include Florida, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06680375 about?

NCT06680375 is a clinical study titled "A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in Adults". 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...

What is the current status of trial NCT06680375?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2024-11-11. Estimated completion is 2025-06-09.

What conditions does trial NCT06680375 study?

This clinical trial studies the following conditions: COVID-19. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06680375?

The interventions under investigation include: Flu Seasonal /SARS-CoV-2 mRNA Dose 1 (COMBINATION_PRODUCT), Flu Seasonal /SARS-CoV-2 mRNA Dose 2 (COMBINATION_PRODUCT), Flu Seasonal mRNA (COMBINATION_PRODUCT), SARS-CoV-2 mRNA Dose 1 (COMBINATION_PRODUCT), SARS-CoV-2 mRNA Dose 2 (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06680375?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06680375 being conducted?

This trial has 9 study locations across Alabama, California, Florida, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial