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

PHASE1CompletedINTERVENTIONAL
Enrollment

470

Participants

Timeline

Start Date

September 8, 2017

Primary Completion Date

March 26, 2020

Study Completion Date

March 26, 2020

Conditions
Influenza, Human
Interventions
BIOLOGICAL

D-SUIV cH8/1N1+AS03

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.

BIOLOGICAL

D-SUIV cH5/1N1+AS03

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.

BIOLOGICAL

D-SUIV cH11/1N1+AS03

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.

BIOLOGICAL

D-SUIV cH8/1N1+AS01

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.

BIOLOGICAL

D-SUIV cH5/1N1+AS01

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.

BIOLOGICAL

D-SUIV cH11/1N1+AS01

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.

BIOLOGICAL

D-SUIV cH8/1N1

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.

BIOLOGICAL

D-SUIV cH5/1N1

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.

BIOLOGICAL

D-SUIV cH11/1N1

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.

BIOLOGICAL

Placebo

1 dose of Phosphate Buffered Saline (PBS) was administered IM in the deltoid region of non-dominant arm.

BIOLOGICAL

Fluarix Quadrivalent

1 Primary dose and 1 Booster dose was administered IM in the deltoid region of non-dominant arm.

Trial Locations (6)

2610

GSK Investigational Site, Wilrijk

14609

GSK Investigational Site, Rochester

23502

GSK Investigational Site, Norfolk

33143

GSK Investigational Site, South Miami

67207

GSK Investigational Site, Wichita

78705

GSK Investigational Site, Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY