This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups. Treatments will comprise two identical IM doses 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
280
Q-Pharm Pty Limited
Herston, Queensland, Australia
CMAX
Adelaide, South Australia, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Assessment of Safety
Number (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 35 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year post-second injection.
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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