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
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: FLU-Q-PAN H7N9 Formulation 1; FLU-Q-PAN H7N9 Formulation 2; FLU-Q-PAN H7N9 Formulation 3; AS03B; AS03A; Placebo
Intervention description: Participants received two doses of the FLU-Q-PAN H7N9 Formulation 1 vaccine by intramuscular injection in the non-dominant arm.; Participants received two doses of the FLU-Q-PAN H7N9 Formulation 2 vaccine by intramuscular injection in the non-dominant arm.; Participants received two doses of the FLU-Q-PAN H7N9 Formulation 3 vaccine by intramuscular injection in the non-dominant arm.; Participants received two doses of the AS03B adjuvant by intramuscular injection in the non-dominant arm.; Participants received two doses of the AS03A adjuvant by intramuscular injection in the non-dominant arm.; Participants received two doses of Placebo by intramuscular injection in the non-dominant arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 833.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.