The purpose of the study is to identify the optimal dose level of a reverse genetic (RG) reassortant H9N2 pandemic influenza vaccine for further product development.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
353
Two intramuscular vaccinations; 5 dose groups: 3.75 µg, 7.5 µg, 15 µg, 30 µg or 45 µg HA antigen (strain A/H9N2/chicken/Hong Kong/G9/97; non-adjuvanted formulation
Accelovance
Huntsville, Alabama, United States
Accelovance
Melbourne, Florida, United States
Accelovance
Peoria, Illinois, United States
Accelovance
South Bend, Indiana, United States
Accelovance
Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination
Time frame: 21 days after 2nd vaccination
Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination
Time frame: 21 days after 2nd vaccination
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Time frame: 7 days after 1st and 2nd vaccination
Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination
Time frame: 21 days after 1st vaccination
Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20
Time frame: 21 days after 1st and 2nd vaccination
Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2
Time frame: 21 days after 1st and 2nd vaccination
Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays
Time frame: 21 days after 1st and 2nd vaccination
Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Time frame: 21 days after 1st and 2nd vaccination
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Rockville, Maryland, United States
Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline
Time frame: 21 days after 1st vaccination
Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline
Time frame: 21 days after 1st and 2nd vaccination
Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination
Time frame: 21 days after 1st and 2nd vaccination
Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays
Time frame: 180 days after 1st vaccination
Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays
Time frame: 180 days after 1st vaccination
Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Time frame: 180 days after 1st vaccination
Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination
Time frame: 7 days after 1st and 2nd vaccination
Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period
Time frame: Through study completion by all subjects, an average of 181 days (+/- 14 days)