A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: D-SUIV cH8/1N1+AS03; D-SUIV cH5/1N1+AS03; D-SUIV cH11/1N1+AS03; D-SUIV cH8/1N1+AS01; D-SUIV cH5/1N1+AS01; D-SUIV cH11/1N1+AS01; D-SUIV cH8/1N1; D-SUIV cH5/1N1; D-SUIV cH11/1N1; Placebo; Fluarix Quadrivalent
Intervention description: 1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 03 (AS03) was administered intramuscularly (IM) in the deltoid region of non-dominant arm.; 1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.; 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.; 1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.; 1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.; 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.; 1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.; 1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.; 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.; 1 dose of Phosphate Buffered Saline (PBS) was administered IM in the deltoid region of non-dominant arm.; 1 Primary dose and 1 Booster dose was administered IM in the deltoid region of non-dominant arm.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The site staff will work in an observer-blind manner. As the vaccines appearance and preparation are different, two teams of study personnel will be set up:
A team of unblinded personnel (responsible for the reception, preparation and administration of the vaccines).
A team of blinded personnel (responsible for the clinical safety evaluation of the subjects).
Enrollment: 470.0
Sex: All
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Healthy adults; Immunogenicity; Supra-seasonal universal influenza vaccines - inactivated (SUIVs)

Summary:

      The purpose of this study is to assess the reactogenicity, safety and immunogenicity of
      different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal
      universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old
      healthy subjects. Subjects will be enrolled and vaccinated with one or 2 primary dose(s)
      followed by a booster dose one year later.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol.

          -  Written informed consent obtained from the subject prior to performance of any study
             specific procedure.

          -  A male or female between, and including, 18 and 39 years of age at the time of the
             first vaccination.

          -  Healthy subjects without acute or chronic, clinically significant pulmonary,
             cardiovascular, hepatic or renal functional abnormality, as established by medical
             history and clinical examination before first vaccination and laboratory screening
             tests (the latter being only applicable for subjects enrolled in Phase I).

          -  Subjects with no history of influenza vaccination within 6 months prior to first study
             vaccination and who are willing to forego any influenza vaccination during the entire
             study period.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  Has practiced adequate contraception for 30 days prior to first 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 (last vaccination at
                  Month 14).

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccines
             during the period starting 30 days before the first dose of study vaccines, or planned
             use during the study period.

          -  Any medical condition that in the judgment of the investigator would make
             intramuscular injection unsafe.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs during
             the period starting 6 months prior to the first vaccine dose. For corticosteroids,
             this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are
             allowed.

          -  Administration of long-acting immune-modifying drugs within 6 months before first
             vaccination, or planned administration any time during the study period.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             in the period starting 30 days before the first dose up to the blood sampling at Day
             85 and in the period starting 30 days before booster vaccination at Month 14 up to the
             blood sample at Month 14 + 28 days.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational vaccine/product.

          -  Previous vaccination against influenza within the 6 months preceding the first
             vaccination at Visit 1 or planned use of such vaccines during the study period.

          -  History of vaccination with a (pre)pandemic influenza vaccine other than an H1N1pdm09
             vaccine or history of laboratory-confirmed influenza infection other than seasonal or
             H1N1pdm09 influenza.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of or current autoimmune disease.

          -  Subjects diagnosed with excessive daytime sleepiness or narcolepsy; or history of
             narcolepsy in a subject's parent or sibling.

          -  History of Guillain-Barré syndrome.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a
             history of severe adverse reaction to a previous influenza vaccine.

          -  Hypersensitivity to latex.

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for
                  measuring temperature in this study will be the oral cavity.

               -  Subjects with a minor illness without fever may be enrolled at the discretion of
                  the investigator.

               -  For subjects with acute disease and/or fever at the time of enrolment, Visit 1
                  may be re-scheduled within the allowed time-window.

          -  Administration of immunoglobulins and/or any blood products during the period starting
             3 months before the first dose of study vaccines or planned administration during the
             study period.

          -  Blood donation within 30 days before the first study blood sampling or planned blood
             donation within 30 days before and up to 30 days after any study blood sampling.

          -  Pregnant or lactating female.

          -  History of chronic alcohol consumption and/or drug abuse as deemed by the investigator
             to render the potential subject unable/unlikely to provide accurate safety reports.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

        Additional criterion applicable for Phase I subjects:

          -  Hematological and/or biochemical parameters outside the laboratory normal ranges,
             unless the laboratory abnormalities are considered not clinically significant by the
             investigator.

          -  Liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST])
             outside of the normal laboratory ranges.