The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
424
One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21
One dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 0 and the second dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 21
One dose of placebo administered IM at the deltoid region of arm at Day 0 and the second dose of placebo administered IM at the deltoid region of arm at Day 21
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Boise, Idaho, United States
GSK Investigational Site
Erie, Pennsylvania, United States
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
The following aggregate variables will be calculated for each adjuvanted H7N9 vaccine group: • Seroconversion rates (SCR); • Seroprotection rates (SPR); • Mean Geometric Increase (MGI)
Time frame: At Day 42
Occurrence of each solicited local symptom
Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination
Occurrence of each solicited general symptom
Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: At Day 0 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: At Day 7 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: At Day 21 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: At Day 28 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: At Day 42 visit
Occurrence of unsolicited adverse events
Time frame: 21 days after each dose
Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)
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GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Truro, Nova Scotia, Canada
GSK Investigational Site
Woodstock, Ontario, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
Time frame: From Day 0 until the Day 42
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
The following aggregate variables will be calculated for each adjuvanted (GSK3206641A) vaccine group which successfully meets CBER and CHMP criteria, and for the unadjuvanted (GSK3206640A) plain antigen vaccine group: • Geometric mean reciprocal serum HI antibody titers (GMTs); • SCR
Time frame: At Day 42
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
The following aggregate variables will be calculated for the unadjuvanted plain antigen vaccine group: • SCR; • SPR; • MGI
Time frame: At Day 42
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers
The following aggregate variables will be calculated for each study group: • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI
Time frame: GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 (Placebo group only) and Months 6 and 12; SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum
The following aggregate variables will be calculated for each study group by age stratum (18-40 years; 41-64 years): • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI
Time frame: GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 and Months 6 and 12
Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers
The following parameters will be calculated for a subset of subjects in each study group: • GMTs; • Seropositivity rates; • Vaccine response rate (VRR)
Time frame: GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6; VRR at Days 21, 42 and Month 6
Occurrence of MAEs, pIMDs and SAEs
Time frame: Until the Month 12 visit