This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,330
Nothern California Clinical Research
Redding, California, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
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 concentration as EU (GMEU) * Geometric mean ratio (GMR) * Seroresponse rate (SRR) * Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
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, over 56 days post-dosing (Year 2). In addition, MAEs, SAEs, and SNMCs will be collected for 1 year (approximately 364 days) post-dosing
Time frame: Day 0 to Day 364
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
Summarized by: * Geometric mean concentrations (GMC) * Geometric mean ratio (GMR) * Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Time frame: Day 0 to Day 182
Neutralizing antibody titer to at least one RSV/A and one RSV/B strain.
Summarized by: * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Time frame: Day 0 to Day 182
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