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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 is a Phase 2 study that has completed, run by Seqirus. The registered enrollment target is 480 participants.
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2023-06-07 |
| Est. Completion | 2024-09-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05874713
The ClinicalTrials.gov registry entry for NCT05874713 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seqirus, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which aH5N6c on Day 1 is the first listed.
NCT05874713 reports 0 study locations.
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.
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