The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18 to 64 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
422
2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm.
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Edison, New Jersey, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Sherbrooke, Quebec, Canada
Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Time frame: Day 21
Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Time frame: Day 42
Humoral immune response in terms of HI antibodies against H9N2 antigen
Time frame: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of HI antibodies against H9N2 antigen for each vaccine group and for age strata (18-40 years; 41-64 years)
Time frame: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of HI antibodies against any drift strain from H9N2 antigen or against any other H9 subtype antigen
Time frame: GMTs and seropositivity rates on Days 0, 7, 21, 28, 42, 182 , 191, 385 and 546. SCR and MGI on Days 21, 42, 182, 191, 385, 546. SPR on Days 0, 21, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of neutralizing (MN) antibodies against H9N2 and against any drift strain (or other H9 subtype)
Time frame: GMTs and seropositivity rate on Days 0, 21, 42, 182, 191, 385 and 546. VRR on Days 21, 42, 182, 191, 385, 546. Booster-VRR on Day 191, 385 and 546.
Occurrence of local and general symptoms
Time frame: During the 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after any vaccination
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Occurrence and relationship to vaccination of unsolicited adverse events
Time frame: Within 21 days (Day 0 to Day 20, 21 to 41, 182 to 202) after any vaccination
Occurrence and relationship to vaccination of adverse events with medically attended visits
Time frame: During the entire study period (Day 0 - Day 546)
Occurrence and relationship to vaccination of Adverse events of special interest (AESIs), potential Immune-Mediated Diseases (pIMDs), Serious Adverse Events (SAEs) and adverse pregnancy outcome
Time frame: During the entire study period (Day 0 - Day 546)
Number of subjects with clinical safety laboratory abnormalities
Time frame: Days 0, 7, 21, 28, 42, 182, 191, and 385.