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NCT07464314 · ClinicalTrials.gov registry record · Phase 1

A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults

A Phase 1 study, sponsored by GlaxoSmithKline.

Recruiting
Registry status
Phase 1
Development phase
225
Enrollment target

NCT07464314: Recruiting Phase 1 study, sponsored by GlaxoSmithKline.

NCT07464314 is a Phase 1 study that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 225 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (275% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07464314, a Phase 1 study, is actively recruiting participants, sponsored by GlaxoSmithKline.

RECRUITING
Registry status
Phase 1
Development phase
225 participants
Enrollment target

Study Summary

This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The study will assess any side effects or health issues, and additional blood samples will be collected at specific times to evaluate how well participants bodies build protection against the flu and COVID-19.

Primary Outcome

The assessed toxicity grades for laboratory value abnormalities will be defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Potentially life-threatening.

Interventions

  • BIOLOGICAL Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine
  • BIOLOGICAL Licensed Seasonal Influenza Vaccine
  • BIOLOGICAL Licensed COVID-19 Vaccine

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2026-03-09
Est. Completion 2027-06-03
Phase Phase 1
GlaxoSmithKline

1,345 total trials

What NCT07464314 shows while recruiting

NCT07464314 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (275% higher).

The record links to 0 conditions, and to 3 interventions - of which Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine is the first listed.

NCT07464314 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07464314 about?

NCT07464314 is a clinical study titled "A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults". This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The st...

What is the current status of trial NCT07464314?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 225 participants. The study started on 2026-03-09. Estimated completion is 2027-06-03.

What interventions are being tested in trial NCT07464314?

The interventions under investigation include: Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine (BIOLOGICAL), Licensed Seasonal Influenza Vaccine (BIOLOGICAL), Licensed COVID-19 Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT07464314?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07464314's enrollment target sits among peer trials

225 223rd of 2000 higher than 1,774 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07464314, the US trial registry maintained by the National Library of Medicine. NCT07464314 (mid enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.