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Virus Vaccine

Arm A for Viral Diseases

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 22, day 43, day 202, day 209, day 223
Awards & highlights

Study Summary

This trial is testing 3 different regimens of a flu vaccine in 480 subjects to determine its effectiveness.

Eligible Conditions
  • Viral Diseases
  • Viral Infections
  • Flu
  • Infections
  • Respiratory Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 22, day 43, day 202, day 209, day 223
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 22, day 43, day 202, day 209, day 223 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GMFI of HI antibodies against H5N6 strain - Day 22
GMFI of HI antibodies against H5N6 strain - Day 223
GMFI of HI antibodies against H5N6 strain - Day 43
+31 more
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
+16 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment3 Interventions
Eligible subjects who have been randomized to receive aH5N6c on Day 1 and aH5N8c on Day 22 and Day 202
Group II: Arm BExperimental Treatment3 Interventions
Eligible subjects who have been randomized to receive aH5N8c on Day 1, aH5N6c on Day 22, and aH5N8c on Day 202
Group III: Arm AExperimental Treatment3 Interventions
Eligible subjects who have been randomized to receive aH5N8c on Day 1, Day 22 and Day 202
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
aH5N8c on Day 1
2023
Completed Phase 2
~480
aH5N6c on Day 1
2022
Completed Phase 2
~740
aH5N8c on Day 22
2023
Completed Phase 2
~480
aH5N6c on Day 22
2022
Completed Phase 2
~740
aH5N8c on Day 202
2023
Completed Phase 2
~480

Find a Location

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED
85 Previous Clinical Trials
910,062 Total Patients Enrolled
Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,469 Total Patients Enrolled
SeqirusLead Sponsor
59 Previous Clinical Trials
1,080,590 Total Patients Enrolled

Media Library

aH5N6c (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05874713 — Phase 2
Viral Diseases Research Study Groups: Arm A, Arm B, Arm C
Viral Diseases Clinical Trial 2023: aH5N6c Highlights & Side Effects. Trial Name: NCT05874713 — Phase 2
aH5N6c (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05874713 — Phase 2

Frequently Asked Questions

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

Has Arm A acquired the necessary regulatory clearance from the FDA?

"In our risk assessment, Arm A's safety rating was a 2 due to the fact that although there is evidence of its safety, no efficacy data has been confirmed."

Answered by AI

How many locations have been selected to conduct this trial?

"This research trial can be accessed at 9 medical sites across the country, including Lilburn, Norcross and Sioux City. Choosing a clinic in close proximity may help reduce your travel burden if you choose to take part."

Answered by AI

Are there any opportunities to join this research initiative at present?

"According to the information found on clinicaltrials.gov, this research project is no longer actively recruiting participants. It was originally posted in June of 2023 and last modified in May 15th of that same year. Despite this trial being closed off for enrollment, 1002 other medical studies are presently welcoming new patients."

Answered by AI

What goals are researchers hoping to fulfill with this experiment?

"The primary objective of this clinical trial, to be measured within 22 days, is the generation of GMT antibodies against H5N8 strain. Secondary goals include quantifying frequency and severity of adverse events (AEs), serious AEs (SAEs) causing withdrawal from the study, AE's of special interest (AESI) as well as medically attended AEs (MAAEs). Additionally, GMT antibody persistence 6 months after both priming vaccination and booster shot will also be monitored."

Answered by AI

Who else is applying?

What site did they apply to?
Cullman Clinical Trials
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults
2023. "Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05874713.
~250 spots leftby May 2025
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