← Back to Search

Virus Therapy

H5N8 Flu Vaccine + AS03 Adjuvant for Flu

Phase 1 & 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
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 7 days after the second study intervention dose (administered at day 22)
Awards & highlights

Study Summary

This trial tests the safety & effectiveness of a new flu vaccine in adults 18 & over.

Who is the study for?
Adults aged 18 or older who are medically stable and can give informed consent. Eligible participants must not have immune system problems, a recent history of cancer (except certain cases), or be receiving immunosuppressive treatments. Pregnant or breastfeeding women, those planning to become pregnant soon, and individuals with a history of severe vaccine reactions are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of two different formulations of an H5N8 influenza vaccine combined with AS03 adjuvant in adults. The goal is to determine how well these vaccines generate an immune response against the flu virus.See study design
What are the potential side effects?
Potential side effects may include typical vaccine-related reactions such as soreness at the injection site, fatigue, headache, muscle pain, feverish feelings, and possible allergic responses to components within the vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after the second study intervention dose (administered at day 22)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after the second study intervention dose (administered at day 22) 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 rise (GMFR) of serum HI antibody titers against vaccine-homologous H5N8
Hemagglutination-inhibiting (HI) antibody titers against vaccine-homologous H5N8
Percentage of participants reporting MAEs
+9 more
Secondary outcome measures
GMFR of serum HI antibody titers against vaccine-homologous H5N8
HI antibody titers against vaccine-homologous H5N8
Microneutralization (MN) antibody titers for a subset of participants
+5 more

Trial Design

4Treatment groups
Active Control
Group I: FLU Q-PAN H5N8 Formulation 2_A GroupActive Control2 Interventions
Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
Group II: FLU Q-PAN H5N8 Formulation 1_B GroupActive Control2 Interventions
Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
Group III: FLU Q-PAN H5N8 Formulation 1_A GroupActive Control2 Interventions
Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
Group IV: FLU Q-PAN H5N8 Formulation 2_B GroupActive Control2 Interventions
Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,753 Previous Clinical Trials
8,069,170 Total Patients Enrolled

Frequently Asked Questions

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

Where are the active sites for this investigation?

"Currently, the trial is recruiting from 20 different cities across America. Some of these locations are Mobile, Tempe and Chula Vista; making it easy to find a site that is near you and reduce travel requirements if participating."

Answered by AI

Is the research study currently recruiting participants?

"The facts hosted on clinicaltrials.gov suggest that this medical trial is currently open to patient recruitment, after having been posted on August 3rd 2023 and edited most recently on October 10th of the same year."

Answered by AI

Has the FDA granted authorization for FLU Q-PAN H5N8 Formulation 1_B Group?

"The safety of FLU Q-PAN H5N8 Formulation 1_B Group has been estimated at a 2 due to Phase Two trials demonstrating some evidence for protection but not yet any efficacy."

Answered by AI

What is the current capacity for participants in this clinical trial?

"Yes, the information hosted on clinicaltrials.gov confirms that this trial is actively seeking participants and has been since August 3rd 2023. The most recent update was made on October 3rd 2023, in which 520 patients were requested from 20 medical centres."

Answered by AI

What is the end goal of this experiment?

"The principal metric to evaluate this trial's progress is the percentage of patients that report unanticipated adverse events over a 43 day period. Additionally, there will be an assessment of microneutralization antibody titers for 50% of participants (260 people). This includes measuring the rate of seropositive responses and vaccine response criteria in relation to the lower limit of quantification."

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults
2023. "Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05975840.
~311 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top