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
NCT ID: NCT05975840
Last Updated: 2025-08-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
518 participants
INTERVENTIONAL
2023-08-03
2024-09-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older
NCT04789577
A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults
NCT06382311
H5N1 Mix and Match With AS03
NCT01317758
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older
NCT05553301
H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults: Immunology
NCT03014310
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Age group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.
FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375\_B vaccine formulation by intramuscular injection in the non-dominant arm.
Age group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.
FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375\_A vaccine formulation by intramuscular injection in the non-dominant arm.
Age group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.
FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750\_B vaccine formulation by intramuscular injection in the non-dominant arm.
Age group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750\_A vaccine formulation by intramuscular injection in the non-dominant arm.
Age group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.
FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375\_B vaccine formulation by intramuscular injection in the non-dominant arm.
Age group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.
FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375\_A vaccine formulation by intramuscular injection in the non-dominant arm.
Age group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.
FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750\_B vaccine formulation by intramuscular injection in the non-dominant arm.
Age group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750\_A vaccine formulation by intramuscular injection in the non-dominant arm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375\_B vaccine formulation by intramuscular injection in the non-dominant arm.
FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375\_A vaccine formulation by intramuscular injection in the non-dominant arm.
FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750\_B vaccine formulation by intramuscular injection in the non-dominant arm.
FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750\_A vaccine formulation by intramuscular injection in the non-dominant arm.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A male or female \>=18 years of age at the time of signing consent form.
* Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
* Female participants of childbearing potential or non-childbearing potential may be enrolled in the study if specific criteria are met.
Exclusion Criteria
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Clinically significant acute or chronic pulmonary, cardiovascular, hepatic, or renal disease that appears uncontrolled or untreated, as determined by history or physical examination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history, physical examination, or abnormalities in screening blood tests.
* Recurrent history of or uncontrolled neurological disorders or seizures.
* History of Guillain-Barré syndrome.
* Diagnosed with cancer, or treatment for cancer within 3 years.
* Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
* Persons with a history of histologically confirmed basal cell carcinoma of the skin successfully treated with local excision only, are accepted and are eligible, but other histologic types of skin cancer are exclusionary.
* Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible.
* Documented human immunodeficiency virus-positive participants.
* Bedridden participants.
* Personal or family history of narcolepsy.
* Food and Drug Administration (FDA) toxicity Grade 2, or greater, laboratory tests at Screening.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
* Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the entire study period.
* Use of public health emergency vaccines like coronavirus disease 2019 (COVID-19), Monkey pox (mpox) etc. These can be given at any time, but there should a gap of 2 - weeks before a dose of study vaccine can be given.
* Use of any licensed vaccines: prior to receipt of the study vaccine and continuing up to 3 weeks after receiving the dose 2 of study vaccine.
* Administration of long-acting immune-modifying drugs at any time during the study period.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose and through the entire study period. For corticosteroids, this will mean prednisone equivalent \>=20 milligrams/day for 14 days or a total of \>=280 mg of prednisone equivalent dose in any 14-day period. Inhaled and topical steroids are allowed.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.
* History of/or current drug/alcohol abuse.
* Any study personnel or their immediate dependents, family, or household member.
* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Anniston, Alabama, United States
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Tempe, Arizona, United States
GSK Investigational Site
Chula Vista, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Santa Ana, California, United States
GSK Investigational Site
Pembroke Pines, Florida, United States
GSK Investigational Site
Chamblee, Georgia, United States
GSK Investigational Site
Meridian, Idaho, United States
GSK Investigational Site
El Dorado, Kansas, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Metairie, Louisiana, United States
GSK Investigational Site
Anderson, South Carolina, United States
GSK Investigational Site
Knoxville, Tennessee, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Boerne, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Tomball, Texas, United States
GSK Investigational Site
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
219833
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.