Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is anticipated that some of the randomized study subjects may not complete the study; subjects who withdraw or are discontinued, will not be replaced. Randomization will be stratified by age (60 to \<75 years and ≥ 75 years) in order to distribute the proportion of such persons in each age group equally across treatment groups. Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A rescue dose of the licensed TIV will be provided to subjects in all groups except the placebo group on Day 28, the placebo group will receive saline. For each subject, study follow-up will span approximately one year from the first immunization (on Day 0) for all subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
220
0.5mL IM injections
0.5mL IM injections
0.5mL IM injections
0.5mL IM injections
0.5mL IM Injections
Genova Clinical Research
Tucson, Arizona, United States
Accelovance
Melbourne, Florida, United States
Research Across America
Dallas, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Assessment of Safety
Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post injection; all adverse events, solicited and unsolicited over 56 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year.
Time frame: Day 0 to Day 364
Immunogenicity as assessed by serum IgG antibody titers for the F-Protein antigen
Immunogenicity will be measured using derived / calculated endpoints based on: * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Time frame: Day 0 to Day 364
Immunogenicity as assessed by serum HAI titers specific for the influenza antigens contained in the seasonal vaccine.
Immunogenicity will be measured using derived / calculated endpoints based on: * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroprotection rate (SPR)
Time frame: Day 0 to Day 56
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