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Virus Therapy

aH5N6c on Day 22 for Flu

Phase 2
Waitlist Available
Research Sponsored by Seqirus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 8, day 22, day 43, day 202
Awards & highlights

Study Summary

This trial is investigating whether two priming doses of aH5N1c followed by one or two booster vaccinations with aH5N6c 3 weeks apart can elicit an immune response to both H5N1 and H5N6. The study will last for approximately 7 months per subject, and safety will be monitored throughout.

Eligible Conditions
  • Flu
  • Infections
  • Avian Influenza
  • Respiratory Diseases
  • Respiratory Infection
  • RNA Virus Infections
  • Viral Diseases
  • Influenza (Flu)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 8, day 22, day 43, day 202
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 8, day 22, day 43, day 202 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric Mean Fold Increase (GMFI) of HI antibodies against H5N6 strain
Geometric Mean Titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N6 strain
Secondary outcome measures
Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI) and medically attended AEs (MAAEs)
Frequency and severity of solicited local and systemic adverse events (AEs)
Frequency and severity of unsolicited AEs
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment2 Interventions
Eligible subjects who received placebo in the parent study V89_18 receive two aH5N6c vaccinations, 3 weeks apart.
Group II: Group 2Experimental Treatment2 Interventions
Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 and have been randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22
Group III: Group 1Experimental Treatment2 Interventions
Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 and have been randomized to receive two aH5N6c vaccinations, 3 weeks apart
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
aH5N6c on Day 22
2022
Completed Phase 2
~740
aH5N6c on Day 1
2022
Completed Phase 2
~740
Placebo on Day 22
2022
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

SeqirusLead Sponsor
59 Previous Clinical Trials
1,080,810 Total Patients Enrolled
Therapeutic Area HeadStudy ChairSeqirus
2 Previous Clinical Trials
1,319 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots available for participants in this clinical investigation?

"Per the details on clinicaltrials.gov, this trial is not admitting patients at this time; it was initially posted on July 18th 2022 and last updated October 8th 2022. However, there are 1042 other trials actively recruiting participants currently."

Answered by AI

What is the primary purpose of this clinical investigation?

"The primary goal of this clinical trial, assessed at Day 1, Day 8, and Days 22/43 is to determine the Geometric Mean Fold Increase (GMFI) in HI antibodies against H5N6 strain. Secondary metrics include Percentage of subjects with HI titers ≥1:40 against H5N1 strain pre-vaccination and post-vaccinations one & two; Frequency and severity of solicited local and systemic adverse events for seven days following each vaccination; along with Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AESI’s, MAAE's from injection until study"

Answered by AI

Could you enumerate the various locations where this clinical trial is being conducted?

"Rochester Clinical Research, Inc. in Rochester, New york is the primary trial site for this study. Secondary sites include Synexus in Chandler, Arizona and Innovative Research of West Florida, Inc. in Clearwater, Florida with an additional 19 locations across America also participating."

Answered by AI

Could you elucidate the safety profile of aH5N6c after three weeks?

"Taking into account the Phase 2 status of aH5N6c, our team has assigned it a safety rating of 2 on Day 22 due to data existing in support of its safety but not efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
Clinical Research Consortium Arizona
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I'm trying to find the phone number for the study I was in.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05422326.
~95 spots leftby Apr 2025
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