This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise \~67% of subjects in each treatment group, and the balance will comprise subjects 50 to 64 years. Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
610
Diablo Clinical Research
Walnut Creek, California, United States
Miami Research Associates
Miami, Florida, United States
Advanced Clinical Research
Meridian, Idaho, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Assessment of Safety
Counts (and percentages) of subjects with solicited local and systemic AEs over the seven days post-injection and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 42 days post-first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
Time frame: Day 0 to Day 384
Immunogenicity as assessed by hemagglutination-inhibiting (HAI) antibody titers against the vaccine-homologous A/Anhui/1/13 (H7N9) virus.
Geometric mean titer (GMT) Geometric mean ratio (GMR) Seroconversion rate (SCR) Seroresponse rate (SRR)
Time frame: Day 0 to Day 384
Immunogenicity as assessed by neuraminidase-inhibiting antibodies to N9.
Time frame: Day 0 to Day 384
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Coastal Carolina Research
Mt. Pleasant, South Carolina, United States