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NCT05422326 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed
A Phase 2 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
NCT05422326 is a Phase 2 study that has completed, run by Seqirus. The registered enrollment target is 260 participants.
The verdict
NCT05422326, a Phase 2 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, multi-center study in approximately 300 adults who received 2 doses of aH5N1c or placebo in and completed the parent study V89\_18 in the \<65 years of age cohort. The study investigates whether two priming doses of MF59-adjuvanted H5N1 cell culture-derived vaccine (aH5N1c) followed by one or two booster vaccinations with a MF59-adjuvanted H5N6 cell culture derived vaccine (aH5N6c) 3 weeks apart elicit immune responses to the antigens used for priming (H5N1) and boosting (H5N6) after first and second heterologous booster vaccination. Eligible subjects, who received 2 doses of aH5N1c in the parent study V89\_18 are randomized in a 1:1 ratio to receive either two aH5N6c vaccinations, 3 weeks apart (group 1) or an aH5N6c vaccination on Day 1 and saline placebo on Day 22 (group 2). Eligible subjects, who received placebo in the parent study will receive two aH5N6c vaccinations, 3 weeks apart (group 3). After the second vaccine administration, subjects are monitored for approximately 6 months for safety and antibody persistence. The total study duration will be approximately 7 months per subject.
Interventions
- BIOLOGICAL aH5N6c on Day 1
- BIOLOGICAL aH5N6c on Day 22
- BIOLOGICAL Placebo on Day 22
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2022-07-18 |
| Est. Completion | 2023-03-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05422326
The ClinicalTrials.gov registry entry for NCT05422326 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 260 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 3 interventions - of which aH5N6c on Day 1 is the first listed.
NCT05422326 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05422326 about?
NCT05422326 is a clinical study titled "A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed". This is a Phase 2, randomized, multi-center study in approximately 300 adults who received 2 doses of aH5N1c or placebo in and completed the parent study V89\_18 in the \<65 years of age cohort. The study investigates whether two priming doses of MF59-adjuvanted H5N1 cell culture-derived vaccine (aH...
What is the current status of trial NCT05422326?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2022-07-18. Estimated completion is 2023-03-24.
What interventions are being tested in trial NCT05422326?
The interventions under investigation include: aH5N6c on Day 1 (BIOLOGICAL), aH5N6c on Day 22 (BIOLOGICAL), Placebo on Day 22 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05422326?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
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