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
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Current seasonal influenza vaccines show good efficacy when they are well-matched with the
      circulating virus strains.

      However, influenza viruses constantly change their surface glycoproteins that are the targets
      of most immune responses, allowing them to escape pre-existing immunity, a process called
      antigenic drift. Therefore, seasonal influenza vaccines have to be reformulated and
      re-administered on an annual basis. In addition, novel viruses can appear at irregular
      intervals and cause influenza virus pandemics that can claim millions of lives.

      GSK Biologicals is now developing a new influenza vaccine that contains modified inactivated
      influenza viruses. The purpose of this approach is to elicit an immune response that would
      protect against all current and future circulating influenza strains without having to
      administer the vaccine each year.
    

Intervention name(s): 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 type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Healthy adults; Immunogenicity; Supra-seasonal universal influenza vaccines - inactivated (SUIVs)