Status:
COMPLETED
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza, Human
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the safety and immunogenicity of different formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03 adjuvant system in adults grea...
Eligibility Criteria
Inclusion
- Medically stable participants as established by medical history and clinical examination before entering into the study.
- 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
- Current diagnosis or history of autoimmune disorder(s) except hypothyroidism due to Hashimoto's thyroiditis.
- 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.
Key Trial Info
Start Date :
August 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2024
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT05975840
Start Date
August 3 2023
End Date
September 19 2024
Last Update
August 19 2025
Active Locations (20)
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1
GSK Investigational Site
Anniston, Alabama, United States, 36207
2
GSK Investigational Site
Mobile, Alabama, United States, 36608
3
GSK Investigational Site
Tempe, Arizona, United States, 85281
4
GSK Investigational Site
Chula Vista, California, United States, 91911