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

• Status: Active, not recruiting
• Trial end date: 2022-10-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

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.