The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants aged greater than or equal to (\>=) 60 years in stable health.
RSV is an important cause of serious respiratory infections in adults aged 60 years and older. The current study is divided into four cohorts, evaluating various doses and combinations of RSV preF-based vaccines. Cohort 1 will assess the safety and reactogenicity of different RSV preF-based vaccines. Cohort 2 is an expansion of cohort 1 and will assess both safety and immunogenicity of these different RSV vaccines. based on C1 and 2 data the optimal vaccine composition will be selected and further evaluated in Cohort 3 and 4 including durability and revaccination. Cohort 3 will accumulate safety data on the selected vaccine and optimize its formulation. Cohort 4 is an expansion of several arms in cohort 3, aimed to understand the durability of the immune response induced by the selected vaccine, and to explore the possibility for revaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
132
RSV preF-based vaccine will be administered as intramuscular injection.
Placebo will be administered as intramuscular injection.
Ark Clinical Research
Long Beach, California, United States
Accel Research Sites
DeLand, Florida, United States
Floridian Clinical Research LLC
Miami Lakes, Florida, United States
Number of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Time frame: From Day 1 up to 6 months post vaccination (up to Day 183)
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of participants with AESIs were reported. Thrombosis with thrombocytopenia syndrome (TTS) were considered as potential AESIs.
Time frame: From Day 1 up to 6 months post vaccination (up to Day 183)
Number of Participants With Solicited Local and Systemic Adverse Events (AEs)
Number of participants with solicited local and systemic AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days post vaccination (Day 8)
Number of Participants With Unsolicited Adverse Events (AEs)
Number of participants with unsolicited AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant were not specifically questioned in the participant diary.
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Heartland Research Associates, an AMR Company
Wichita, Kansas, United States
Clinical Trials Management, LLC
Metairie, Louisiana, United States
The Center for Pharmaceutical Research (CPR)
Kansas City, Missouri, United States
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville, Tennessee, United States
...and 1 more locations
Time frame: 28 days post vaccination (Day 29)