This Phase 1, randomized, observer-blind, dose-ranging clinical study is evaluating 6 different formulations of MF59-adjuvanted and non-adjuvanted H2N3 influenza vaccine. Approximately 600 healthy adult subjects are to be randomized into 1 of 6 possible treatment groups with 100 subjects per group, stratified by age group (born after or before 1968). Each subject will receive an influenza vaccine injection on Day 1 and Day 22. Subjects will be followed up for approximately 12 months after the second vaccine injection. The primary immunogenicity analysis is based on the Day 1, Day 8, Day 22, Day 29, and Day 43 serology data. The primary safety analysis is based on solicited local and systemic adverse events (AEs) reported within 10 days after each vaccination, unsolicited AEs reported within 3 weeks after each vaccination, and serious AEs (SAEs), medically attended AEs (MAAEs), AEs leading to withdrawal from the study, and AEs of special interest (AESIs) reported throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
600
Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine
Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine
Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine
Two intramuscular injections (3 weeks apart) of cell culture-derived non-adjuvanted H2N3 vaccine
Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine
Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine
Meridian Clinical Research
Rockville, Maryland, United States
Meridian Clinical Research
Lincoln, Nebraska, United States
Meridian Clinical Research
Omaha, Nebraska, United States
West Visayas State University Medical Center
Iloilo City, Philippines
Manila Doctors Hospital
Manila, Philippines
Quirino Memorial Medical Center
Quezon City, Philippines
Silang Specialists Medical Center
Silang, Philippines
Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against homologous H2N3 strain - Day 1
GMT (HI) prevaccination
Time frame: Day 1
GMT of HI antibodies against homologous H2N3 strain - Day 8
GMT (HI) 1 week postvaccination 1
Time frame: Day 8
GMT of HI antibodies against homologous H2N3 strain Day 22
GMT (HI) 3 weeks postvaccination 1
Time frame: Day 22
GMT of HI antibodies against homologous H2N3 strain - Day 29
GMT (HI) 1 week postvaccination 2
Time frame: Day 29
GMT of HI antibodies against homologous H2N3 strain - Day 43
GMT (HI) 3 weeks postvaccination 2
Time frame: Day 43
GMT of microneutralization (MN) antibodies against homologous H2N3 strain - Day 1
GMT (MN) prevaccination
Time frame: Day 1
GMT of MN antibodies against homologous H2N3 strain - Day 8
GMT (MN) 1 week postvaccination 1
Time frame: Day 8
GMT of MN antibodies against homologous H2N3 strain - Day 22
GMT (MN) 3 weeks postvaccination 1
Time frame: Day 22
GMT of MN antibodies against homologous H2N3 strain - Day 29
GMT (MN) 1 week postvaccination 2
Time frame: Day 29
GMT of MN antibodies against homologous H2N3 strain - Day 43
GMT (MN) 3 weeks postvaccination 2
Time frame: Day 43
Geometric mean fold increase (GMFI) of HI antibodies against homologous H2N3 strain - Day 8
GMFI (HI) 1 week postvaccination 1 compared to prevaccination
Time frame: Day 8
GMFI of HI antibodies against homologous H2N3 strain - Day 22
GMFI (HI) 3 weeks postvaccination 1 compared to prevaccination
Time frame: Day 22
GMFI of HI antibodies against homologous H2N3 strain - Day 29
GMFI (HI) 1 week postvaccination 2 compared to prevaccination
Time frame: Day 29
GMFI of HI antibodies against homologous H2N3 strain - Day 43
GMFI (HI) 3 weeks postvaccination 2 compared to prevaccination
Time frame: Day 43
GMFI of MN antibodies against homologous H2N3 strain - Day 8
GMFI (MN) 1 week postvaccination 1 compared to prevaccination
Time frame: Day 8
GMFI of MN antibodies against homologous H2N3 strain - Day 22
GMFI (MN) 3 weeks postvaccination 1 compared to prevaccination
Time frame: Day 22
GMFI of MN antibodies against homologous H2N3 strain - Day 29
GMFI (MN) 1 week postvaccination 2 compared to prevaccination
Time frame: Day 29
GMFI of MN antibodies against homologous H2N3 strain - Day 43
GMFI (MN) 3 weeks postvaccination 2 compared to prevaccination
Time frame: Day 43
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 1
% ≥1:40 (HI) prevaccination
Time frame: Day 1
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 8
% ≥1:40 (HI) 1 week postvaccination 1
Time frame: Day 8
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 22
% ≥1:40 (HI) 3 weeks postvaccination 1
Time frame: Day 22
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 29
% ≥1:40 (HI) 1 week postvaccination 2
Time frame: Day 29
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 43
% ≥1:40 (HI) 3 weeks postvaccination 2
Time frame: Day 43
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 1
% ≥1:40 (MN) prevaccination
Time frame: Day 1
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 8
% ≥1:40 (MN) 1 week postvaccination 1
Time frame: Day 8
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 22
% ≥1:40 (MN) 3 weeks postvaccination 1
Time frame: Day 22
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 29
% ≥1:40 (MN) 1 week postvaccination 2
Time frame: Day 29
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 43
% ≥1:40 (MN) 3 weeks postvaccination 2
Time frame: Day 43
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 8
% seroconversion (HI) 1 week postvaccination 1, 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 baseline titer \<1:10
Time frame: Day 8
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 22
% seroconversion (HI) 3 weeks postvaccination 1, 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 baseline titer \<1:10
Time frame: Day 22
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 29
% seroconversion (HI) 1 week postvaccination 2, 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 baseline titer \<1:10
Time frame: Day 29
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 43
% seroconversion (HI) 3 weeks postvaccination 2, 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 baseline titer \<1:10
Time frame: Day 43
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 8
% seroconversion (MN) 1 week postvaccination 1, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer \<LLOQ
Time frame: Day 8
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 22
% seroconversion (MN) 3 weeks postvaccination 1, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer \<LLOQ
Time frame: Day 22
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 29
% seroconversion (MN) 1 week postvaccination 2, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer \<LLOQ
Time frame: Day 29
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 43
% seroconversion (MN) 3 weeks postvaccination 2, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer \<LLOQ
Time frame: Day 43
Number and percentages of subjects reporting solicited local and systemic adverse events (AEs) - Day 1 through Day 10
10 consecutive days postvaccination 1
Time frame: Day 1 through Day 10
Number and percentages of subjects reporting solicited local and systemic AEs - Day 22 through Day 31
10 consecutive days postvaccination 2
Time frame: Day 22 through Day 31
Number and percentage of subjects reporting any unsolicited AEs
For 3 weeks following each vaccination
Time frame: Day 1 through Day 43
Number and percentage of subjects reporting serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI) and medically attended AEs (MAAEs)
From vaccination until study completion
Time frame: Day 1 through Day 387
GMT of ELLA titers as a measure of anti-neuraminidase (NA) immunogenicity
GMT (ELLA) prevaccination, 1 and 3 weeks postvaccination
Time frame: Day 1, Day 8, Day 22, Day 29, Day 43
GMFI of ELLA titers as a measure of anti-NA immunogenicity
GMFI (ELLA) 1 and 3 weeks postvaccination compared to prevaccination
Time frame: Day 8, Day 22, Day 29, Day 43
Percentage of subjects with ≥4-fold increase in ELLA titer as a measure of anti-NA immunogenicity
% ≥4-fold increase (ELLA) 1 and 3 weeks postvaccination compared to prevaccination
Time frame: Day 8, Day 22, Day 29, Day 43
GMT of HI antibodies against homologous H2N3 strain - Persistence
GMT (HI) 6 and 12 months postvaccination 2
Time frame: Day 202, Day 387
GMT of MN antibodies against homologous H2N3 strain - Persistence
GMT (MN) 6 and 12 months postvaccination 2
Time frame: Day 202, Day 387
GMT of ELLA titer as a measure of anti-NA immunogenicity- Persistence
GMT (ELLA) 6 and 12 months postvaccination 2
Time frame: Day 202, Day 387
GMFI of HI antibodies against homologous H2N3 strain - Persistence
GMFI (HI) 6 and 12 months postvaccination 2 compared to prevaccination
Time frame: Day 202, Day 387
GMFI of MN antibodies against homologous H2N3 strain - Persistence
GMFI (MN) 6 and 12 months postvaccination 2 compared to prevaccination
Time frame: Day 202, Day 387
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GMFI of ELLA titer as a measure of anti-NA immunogenicity- Persistence
GMFI (ELLA) 6 and 12 months postvaccination 2 compared to prevaccination
Time frame: Day 202, Day 387
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Persistence
% ≥1:40 (HI) 6 and 12 months postvaccination 2
Time frame: Day 202, Day 387
Percentages of subjects with MN titers ≥1:40, ≥1:80 and ≥1:160 against homologous H2N3 strain - Persistence
% ≥1:40, ≥1:80 and ≥1:160 (MN) 6 and 12 months postvaccination 2
Time frame: Day 202, Day 387
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Persistence
% seroconversion (HI) 6 and 12 months postvaccination 2, 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 baseline titer \<1:10
Time frame: Day 202, Day 387
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Persistence
% seroconversion (MN) 6 and 12 months postvaccination 2, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥LLOQ, or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer \<LLOQ
Time frame: Day 202, Day 387
Percentage of subjects with ≥4-fold increase in ELLA titer as a measure of anti-NA immunogenicity - Persistence
% ≥4-fold increase (ELLA) 6 and 12 months postvaccination 2 compared to prevaccination
Time frame: Day 202, Day 387