The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
720
Diablo Clinical Research
Walnut Creek, California, United States
Clincal Research of Atlanta
Stockbridge, Georgia, United States
Advanced Clinical Research
Boise, Idaho, United States
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Derived/calculated endpoints based on these data will include: * Geometric mean concentrations as EU (GMEU) * Geometric mean ratio (GMR) * Geometric mean fold-rise (GMFR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Time frame: Day 0 to Day 56
Assessment of Safety
Numbers and percentages of subjects with solicited local and systemic adverse events over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters. In addition, Medically Attended Events, Serious Adverse Events, and Significant New Medical Conditions will be collected for six months.
Time frame: Day 0 to Day 182
Immunogenicity based on neutralizing antibody titer
Time frame: Day 0 to Day 56
Kinetics of serum IgG antibody titers specific for the F-Protein antigen across time
Time frame: Day 0 to Day 91
Immunogenicity based on antibodies sharing specificity with Palivizumab
Time frame: Day 0 to 91
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