The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of 135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
11,850
Numbers and percentages of subjects with moderate-severe RSV-LRTD
Defined by the presence of at least three (3) of: cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath, and observed tachypnea (≥20 breaths per minute); plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.
Time frame: Day 0 to Day 182
Numbers and percentages of subjects with solicited local and systemic AEs
Defined as solicited local and systemic AEs over the 7 days post-injection; all adverse events, solicited and unsolicited over 56 days after dosing; and MAEs, SAEs, and SNMCs over one year post dosing.
Time frame: Day 0 to Day 364
Numbers and percentages of subjects with RSV-Acute Respiratory Disease (RSV-ARD)
Defined by the presence of at least one (1) of: rhinorrhea, nasal congestion, pharyngitis, cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath; plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.
Time frame: Day 0 to Day 182
RSV F protein antibody expressed as ELISA Units (EU).
Summarized by: * Geometric Mean Concentrations as EU (GMEU) * Geometric Mean Ratio (GMR) * Seroresponse Rate (SRR)
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 as EU (GMEU) * Geometric Mean Fold Rise (GMFR)
Time frame: Day 0 to Day 364
Neutralizing antibody titer to at least one RSV/A and one RSV/B virus strain
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Research Site US062
Birmingham, Alabama, United States
Research Site US061
Mobile, Alabama, United States
Research Site US046
Mesa, Arizona, United States
Research Site US054
Phoenix, Arizona, United States
Research Site US048
Tempe, Arizona, United States
Research Site US005
Anaheim, California, United States
Research Site US028
Redding, California, United States
Research Site US064
San Diego, California, United States
Research Site US045
Savannah, Georgia, United States
Research Site US013
Stockbridge, Georgia, United States
...and 50 more locations
Summarized by: * Geometric Mean Titer (GMT) * Geometric Mean Ratio (GMR)
Time frame: Day 0 to Day 28
Number and percentage of subjects with RSV-ARD and/or RSV-LRTD
Summarized by treatment group and by age strata and in strata defined by comorbidities and type of community housing.
Time frame: Day 0 to Day 364
Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2015-16 IIV at Day 28 in the subset of subjects in each treatment group that receive IIV concurrently with study test article.
Time frame: Day 0 to Day 28