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NCT05823974 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
1,275
Enrollment target

NCT05823974: Completed Phase 1 study, sponsored by GlaxoSmithKline.

NCT05823974 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,275 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2025% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05823974, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
1,275 participants
Enrollment target

Study Summary

The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).

Primary Outcome

Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

Interventions

  • BIOLOGICAL F2C22C/DL001Z
  • BIOLOGICAL F2B22A/DL001Z
  • BIOLOGICAL F2B22B/DL001Z
  • BIOLOGICAL F2B22C/DL001Z
  • BIOLOGICAL F2B22D/DL001Z

Trial Details

FieldValue
Enrollment Target 1,275 participants
Start Date 2023-04-27
Est. Completion 2024-12-18
Phase Phase 1
GlaxoSmithKline

1,345 total trials

What the finished NCT05823974 record still lists

NCT05823974 is an interventional study that assigns participants to a tested intervention. Its 1,275 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2025% higher).

The record links to 0 conditions, and to 5 interventions - of which F2C22C/DL001Z is the first listed.

NCT05823974 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05823974 about?

NCT05823974 is a clinical study titled "A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults". The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).

What is the current status of trial NCT05823974?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,275 participants. The study started on 2023-04-27. Estimated completion is 2024-12-18.

What interventions are being tested in trial NCT05823974?

The interventions under investigation include: F2C22C/DL001Z (BIOLOGICAL), F2B22A/DL001Z (BIOLOGICAL), F2B22B/DL001Z (BIOLOGICAL), F2B22C/DL001Z (BIOLOGICAL), F2B22D/DL001Z (BIOLOGICAL).

Who is sponsoring clinical trial NCT05823974?

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 NCT05823974's enrollment target sits among peer trials

1,275 5th of 2000 higher than 1,996 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 NCT05823974, the US trial registry maintained by the National Library of Medicine. NCT05823974 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.