The purpose of this study is to evaluate the safety and immunogenicity of two investigational vaccines, AZD4117 and AZD5315 to protect against certain strains of avian Influenza A (H5N1 and H7N9 subtypes).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
405
Research Site
Long Beach, California, United States
Research Site
Rolling Hills Estates, California, United States
Research Site
Hialeah, Florida, United States
Percentage of participants with immediate unsolicited adverse events (AE)
Time frame: Within 30 minutes after dosing
Percentage of participants with injection site and systemic solicited adverse reactions (AR)
Time frame: Through 7 days after dosing
Percentage of participants with unsolicited AE
Time frame: Through 28 days after the last dose
Percentage of participants with serious adverse events (SAE)
Time frame: Through 12 months after the last dose
Percentage of participants with medically attended adverse events (MAAE)
Time frame: Through 12 months after the last dose
Percentage of participants with adverse events of special interest (AESI)
Time frame: Through 12 months after the last dose
Proportion of participants achieving ≥ 1:40 HAI titer post-IMP administration
A binary endpoint, defined as ≥ 1:40 HAI titer post-IMP administration.
Time frame: Day 58
Proportion of participants achieving seroconversion post-IMP administration
Seroconversion status, defined as either a pre-IMP administration HAI titer \< 1:10 and a post-IMP administration HAI titer ≥ 1:40, or a pre-IMP administration titer ≥ 1:10 and 4-fold increase in post-IMP administration titer.
Time frame: Day 58
Geometric mean titer (GMT) of HAI antibody
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Research Site
Stockbridge, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Lenexa, Kansas, United States
Research Site
Kansas City, Missouri, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Cincinnati, Ohio, United States
...and 4 more locations
Time frame: Days 1 to 389
Geometric mean fold-rise (GMFR) of HAI antibody titers from baseline
The fold rise is calculated as the ratio of the post-dose titer to the pre-dose titer.
Time frame: Days 29 to 389
Proportion of participants achieving a ≥1:40 HAI titer post-IMP administration
A binary endpoint, defined as ≥ 1:40 HAI titer post-IMP administration.
Time frame: Days 29 to 389
Proportion of participants achieving seroconversion post-IMP administration
Seroconversion status, defined as either a pre-IMP administration HAI titer \< 1:10 and a post-IMP administration HAI titer ≥ 1:40, or a pre-IMP administration titer ≥ 1:10 and 4-fold increase in post-IMP administration titer.
Time frame: Days 29 to 389