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

Conditions: Influenza, Human

Summary: study to evaluate the safety and immunogenicity of h7n9 antigen in combination with full or half doses of as03 adjuvant system in healthy adults.


Eligibility criteria:
inclusion criteria: * healthy 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 first vaccination. * participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards and covid-19 assessment card, return for follow-up visits, or return the diary cards and covid-19 assessment card in a timely manner using the pre stamped envelope received at the site). * written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure. * female participants of non-childbearing potential may be enrolled in the study. non childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion hysterectomy, bilateral ovariectomy or post-menopause. * female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 1 month prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. exclusion criteria: * current diagnosis or history of autoimmune disorder(s). * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * hypersensitivity to latex. * acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality that appears uncontrolled, as determined by history or physical examination. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * recurrent history or uncontrolled neurological disorders or seizures. * history of guillain-barré syndrome. * diagnosed with narcolepsy; or history of narcolepsy in a participant's parent, sibling or child. * 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 (for example, with tamoxifen) are eligible. * documented human immunodeficiency virus-positive participant. * any clinically significant\* hematological laboratory abnormality. \*the investigator should use his/her clinical judgement to decide which abnormalities are clinically significant. * bedridden participants. * 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 (drug, vaccine or medical device) other than the study vaccine/product during the period beginning 30 days before the first dose of study vaccine/product (day -29 to day 1), or planned use during the study period. * administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab). * administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine/product or planned administration during the study period. * chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine/product dose. for corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. inhaled and topical steroids are allowed. * 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 (drug or medical device). * 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 chronic alcohol consumption and/or drug abuse. * any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. * any study personnel or immediate dependents, family, or household member.