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NCT05874713 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults

A Phase 2 study, sponsored by Seqirus.

Completed
Registry status
Phase 2
Development phase
480
Enrollment target

NCT05874713: Completed Phase 2 study, sponsored by Seqirus.

NCT05874713 is a Phase 2 study that has completed, run by Seqirus. The registered enrollment target is 480 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (261% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05874713, a Phase 2 study, has completed, sponsored by Seqirus.

COMPLETED
Registry status
Phase 2
Development phase
480 participants
Enrollment target

Study Summary

This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Approximately 480 healthy adult subjects are to be randomized into 1 of 3 possible treatment groups, stratified by age group (18-64 years and ≥65 years) and by poultry worker status (yes/no). Each subject will receive a priming influenza vaccine injection on Day 1 and Day 22 and a booster vaccination on Day 202. Subjects will be followed up for approximately 6 months after the booster injection. The primary immunogenicity analysis is based on antibody responses against H5N8 and H5N6 as measured by hemagglutination inhibition (HI) assay on Day 1, Day 22, Day 29, Day 43, Day 202, Day 209 (H5N8 only), and Day 223.

Primary Outcome

GMT (HI) prevaccination

Interventions

  • BIOLOGICAL aH5N6c on Day 1
  • BIOLOGICAL aH5N6c on Day 22
  • BIOLOGICAL aH5N8c on Day 1
  • BIOLOGICAL aH5N8c on Day 22
  • BIOLOGICAL aH5N8c on Day 202

Trial Details

FieldValue
Enrollment Target 480 participants
Start Date 2023-06-07
Est. Completion 2024-09-25
Phase Phase 2
Seqirus

25 total trials

What the finished NCT05874713 record still lists

NCT05874713 is an interventional study that assigns participants to a tested intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (261% higher).

The record links to 0 conditions, and to 5 interventions - of which aH5N6c on Day 1 is the first listed.

NCT05874713 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05874713 about?

NCT05874713 is a clinical study titled "Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults". This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Approximately 480 healthy adult subjects are to be randomized into 1 of 3 possible treatment g...

What is the current status of trial NCT05874713?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 480 participants. The study started on 2023-06-07. Estimated completion is 2024-09-25.

What interventions are being tested in trial NCT05874713?

The interventions under investigation include: aH5N6c on Day 1 (BIOLOGICAL), aH5N6c on Day 22 (BIOLOGICAL), aH5N8c on Day 1 (BIOLOGICAL), aH5N8c on Day 22 (BIOLOGICAL), aH5N8c on Day 202 (BIOLOGICAL).

Who is sponsoring clinical trial NCT05874713?

This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05874713's enrollment target sits among peer trials

480 76th of 2000 higher than 1,924 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT05874713, the US trial registry maintained by the National Library of Medicine. NCT05874713 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.