This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Approximately 480 healthy adult subjects are to be randomized into 1 of 3 possible treatment groups, stratified by age group (18-64 years and ≥65 years) and by poultry worker status (yes/no). Each subject will receive a priming influenza vaccine injection on Day 1 and Day 22 and a booster vaccination on Day 202. Subjects will be followed up for approximately 6 months after the booster injection. The primary immunogenicity analysis is based on antibody responses against H5N8 and H5N6 as measured by hemagglutination inhibition (HI) assay on Day 1, Day 22, Day 29, Day 43, Day 202, Day 209 (H5N8 only), and Day 223.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1
Timeframe: Day 1
GMT of HI antibodies against H5N8 strain - Day 22
Timeframe: Day 22
GMT of HI antibodies against H5N8 strain - Day 43
Timeframe: Day 43
GMT of HI antibodies against H5N8 strain - Day 202
Timeframe: Day 202
GMT of HI antibodies against H5N8 strain - Day 209
Timeframe: Day 209
GMT of HI antibodies against H5N8 strain - Day 223
Timeframe: Day 223
GMT of HI antibodies against H5N6 strain - Day 1
Timeframe: Day 1
GMT of HI antibodies against H5N6 strain - Day 22
Timeframe: Day 22
GMT of HI antibodies against H5N6 strain - Day 43
Timeframe: Day 43
GMT of HI antibodies against H5N6 strain - Day 202
Timeframe: Day 202
GMT of HI antibodies against H5N6 strain - Day 223
Timeframe: Day 223
Geometric mean fold increase (GMFI) of HI antibodies against H5N8 strain - Day 22
Timeframe: Day 22
GMFI of HI antibodies against H5N8 strain - Day 43
Timeframe: Day 43
GMFI of HI antibodies against H5N8 strain - Day 209
Timeframe: Day 209
GMFI of HI antibodies against H5N8 strain - Day 223
Timeframe: Day 223
GMFI of HI antibodies against H5N6 strain - Day 22
Timeframe: Day 22
GMFI of HI antibodies against H5N6 strain - Day 43
Timeframe: Day 43
GMFI of HI antibodies against H5N6 strain - Day 223
Timeframe: Day 223
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 1
Timeframe: Day 1
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 22
Timeframe: Day 22
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 43
Timeframe: Day 43
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 209
Timeframe: Day 209
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 223
Timeframe: Day 223
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 1
Timeframe: Day 1
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 22
Timeframe: Day 22
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 43
Timeframe: Day 43
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 223
Timeframe: Day 223
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 22
Timeframe: Day 22
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 43
Timeframe: Day 43
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 209
Timeframe: Day 209
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 223
Timeframe: Day 223
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 22
Timeframe: Day 22
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 43
Timeframe: Day 43
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 223
Timeframe: Day 223