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

Conditions: Influenza, Human

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 greater than or equal to (\>=)18 years of age.


Eligibility criteria:
inclusion criteria: * 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 criteria: * 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.

Keywords: influenza safety immunogenicity