The purpose of this study is to evaluate the safety and immunogenicity of the RSV- F Vaccine in elderly subjects, as well as rate the incidence of medically- attended RSV disease in vaccine and placebo recipients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,599
Nothern California Clinical Research
Redding, California, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen
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) * Seroresponse rate (SRR)
Time frame: Day 0 to Day 364
Number and percentage of subjects with respiratory illness associated with RSV
Defined by any one of rhinorrhea, nasal congestion, pharyngitis, cough, wheezing (or increase in baseline wheezing), sputum production (or increase in the change in nature of baseline sputum production), or new (or worsening) shortness of breath; plus RT-PRC-confirmed RSV infection documented within three days of symptom onset.
Time frame: Day 0 to Day 364
Numbers and percentages of subjects with solicited local and systemic AEs.
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 56 days post injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
Time frame: Day 0 to Day 364
Palivizumab competitive antibody responses based on antibody titers in competitive ELISA.
Summarized by geometric mean titer (GMT), GMR. GMFR, and SRR; as well as seroconversion rate (SCR).
Time frame: Day 0 to Day 182
Neutralizing antibody titer to at least one prototypical RSV/A and one RSV/B virus strain.
Analyzed by GMT,GMR, SCR, and SRR. Neutralizing antibody assays, because of their time intensive nature, will be performed at a selected subset of time-points.
Time frame: Day 0 to Day 182
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Rapid Medical Research
Cleveland, Ohio, United States
Clinical Research Associates
Nashville, Tennessee, United States
Research Across America
Dallas, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
Lisa Jackson
Seattle, Washington, United States
Marshfield Clinical Research Foundation
Wausau, Wisconsin, United States
Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2014-15 vaccine at Day 28.
Time frame: Day 0 to Day 28