Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1
GMT (HI) prevaccination
GMT of HI antibodies against H5N8 strain - Day 22
GMT (HI) 3 weeks post first priming vaccination
GMT of HI antibodies against H5N8 strain - Day 43
GMT (HI) 3 weeks post second priming vaccination
GMT of HI antibodies against H5N8 strain - Day 202
GMT (HI) pre booster vaccination
GMT of HI antibodies against H5N8 strain - Day 209
GMT (HI) 1 week post booster vaccination
GMT of HI antibodies against H5N8 strain - Day 223
GMT (HI) 3 weeks post booster vaccination
GMT of HI antibodies against H5N6 strain - Day 1
GMT (HI) prevaccination
GMT of HI antibodies against H5N6 strain - Day 22
GMT (HI) 3 weeks post first priming vaccination
GMT of HI antibodies against H5N6 strain - Day 43
GMT (HI) 3 weeks post second priming vaccination
GMT of HI antibodies against H5N6 strain - Day 202
GMT (HI) pre booster vaccination
GMT of HI antibodies against H5N6 strain - Day 223
GMT (HI) 3 weeks post booster vaccination
Geometric mean fold increase (GMFI) of HI antibodies against H5N8 strain - Day 22
GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N8 strain - Day 43
GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N8 strain - Day 209
GMFI (HI) 1 week post booster vaccination compared to pre booster vaccination
GMFI of HI antibodies against H5N8 strain - Day 223
GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination
GMFI of HI antibodies against H5N6 strain - Day 22
GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N6 strain - Day 43
GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N6 strain - Day 223
GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 1
% ≥1:40 (HI) prevaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 22
% ≥1:40 (HI) 3 weeks post first priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 43
% ≥1:40 (HI) 3 weeks post second priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 209
% ≥1:40 (HI) 1 week post booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 223
% ≥1:40 (HI) 3 weeks post booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 1
% ≥1:40 (HI) prevaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 22
% ≥1:40 (HI) 3 weeks post first priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 43
% ≥1:40 (HI) 3 weeks post second priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 223
% ≥1:40 (HI) 3 weeks post booster vaccination
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 22
% seroconversion (HI) 3 weeks post first priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 43
% seroconversion (HI) 3 weeks post second priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 209
% seroconversion (HI) 1 week post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 223
% seroconversion (HI) 3 weeks post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 22
% seroconversion (HI) 3 weeks post first priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 43
% seroconversion (HI) 3 weeks post second priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 223
% seroconversion (HI) 3 weeks post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Frequency and severity of solicited local and systemic adverse events (AEs)
For 7 consecutive days following each vaccination (ie, Day 1 through Day 7, Day 22 through Day 28, and Day 202 through 208, or until symptom resolution if ongoing at Day 7, Day 28 or Day 208 for a maximum of 14 days postvaccination).
Frequency and severity of unsolicited AEs
For 3 weeks following each vaccination
Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI), and medically attended AEs (MAAEs)
From first vaccination until study completion
GMT of HI antibodies against H5N8 strain - Persistence
GMT (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination
GMT of HI antibodies against H5N6 strain - Persistence
GMT (HI) 6 months post 2nd priming vaccination
GMFI of HI antibodies against H5N8 strain - Persistence
GMFI (HI) 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 6 months post booster vaccination compared to prevaccination (Day 1) and compared to pre booster vaccination (Day 202)
GMFI of HI antibodies against H5N6 strain - Persistence
GMFI (HI) 6 months post 2nd priming vaccination compared to prevaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Persistence
% ≥1:40 (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Persistence
% ≥1:40 (HI) 6 months post 2nd priming vaccination
Percentages of subjects with seroconversion by HI against H5N8 strain - Persistence
% seroconversion (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Persistence
% seroconversion (HI) 6 months post 2nd priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
GMT of microneutralization (MN) antibodies against H5N8 strain
GMT (MN) prevaccination, 3 weeks post priming vaccinations, pre booster vaccination and 3 weeks post booster vaccination
GMT of MN antibodies against H5N6 strain
GMT (MN) prevaccination, 3 weeks post 2nd priming vaccination, pre booster vaccination and 3 weeks post booster vaccination
GMFI of MN antibodies against H5N8 strain
GMFI (MN) 3 weeks post priming vaccinations and 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 3 weeks post booster vaccination compared to pre booster vaccination (Day 202)
GMFI of MN antibodies against H5N6 strain
GMFI (MN) 3 weeks and 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 3 weeks post booster vaccination compared to pre booster vaccination (Day 202)
Percentages of subjects with MN titers ≥1:40 against H5N8 strain
% ≥1:40 (MN) prevaccination, 3 weeks post priming vaccinations, pre booster vaccination, and 3 weeks post booster vaccination
Percentages of subjects with MN titers ≥1:40 against H5N6 strain
% ≥1:40 (MN) prevaccination, 3 weeks post 2nd priming vaccination, pre booster vaccination, and 3 weeks post booster vaccination
Percentages of subjects with seroconversion by MN against H5N8 strain
% seroconversion (MN) 3 weeks post priming vaccinations, pre booster vaccination, and 3 weeks post booster vaccination, defined as a ≥4-fold increase in MN titer postvaccination for subjects with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with prevaccination titer <LLOQ
Percentages of subjects with seroconversion by MN against H5N6 strain
% seroconversion (MN) 3 weeks post 2nd priming vaccination, pre booster vaccination, and 3 weeks post booster vaccination, defined as a ≥4-fold increase in MN titer postvaccination for subjects with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with prevaccination titer <LLOQ