The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
330
0.5mL IM Injection
0.5ml IM Injection
0.5mL IM Injection
Anaheim Clinical Trials
Anaheim, California, United States
Accelovance Rockville
Rockville, Maryland, United States
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups
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 112
Assessment of the safety
Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post-injections; 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 six months
Time frame: Day 0 to Day 182
Immunogenicity based on neturalizing antibody titer
Time frame: Day 0 to Day 112
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0.5mL IM Injection
0.5mL IM Injection
0.5mL IM Injection