The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,459
1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1.
GSK Investigational Site
Glendale, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
North Hollywood, California, United States
GSK Investigational Site
Oakland, California, United States
GSK Investigational Site
Walnut Creek, California, United States
Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated dilution 60 (ED60)
Time frame: At Day 31
Part A: Percentage of Participants With Seroresponse Rate (SRR) in RSV-A Neutralizing Titers
SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) ≥4. RSV-A neutralizing titers are expressed as ED60.
Time frame: Day 31 compared with baseline (Day 1)
Part A: RSV-B Neutralizing Titers Expressed as Group GMTs
RSV-B neutralizing titers are given as group GMTs and are expressed as ED60.
Time frame: At Day 31
Part A: Percentage of Participants With SRR in RSV-B Neutralizing Titers
SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1-month post-study intervention administration over pre-study intervention administration) ≥ 4. RSV-B neutralizing titers are expressed as ED60.
Time frame: Day 31 compared with baseline (Day 1)
Part A and B: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events were pain, redness (erythema) and swelling at administration site. Any = occurrence of the symptom regardless of intensity grade.
Time frame: Day 1 (post dose) to Day 4
Part A and B: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events were fever (pyrexia), headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever was defined as temperature ≥38.0 degrees Celsius (°C), regardless of the location of measurement. The route for measuring temperature could be oral or axillary. Any = occurrence of the symptom regardless of intensity grade.
Time frame: Day 1 (post dose) to Day 4
Part A and B: Number of Participants Reporting Unsolicited Adverse Events (AEs)
An unsolicited AE wass an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs included both serious and non-serious AEs.
Time frame: Day 1 (post dose) to Day 30
Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of the intensity grade or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.
Time frame: Throughout the study period (Day 1 to Month 6)
Part A and B: Number of Participants Reporting Any Adverse Events of Special Interest (AESIs)
AESIs assessed were potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF). pIMDs were a subset of AESIs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. AEs of AF were considered as AESI.
Time frame: Throughout the study period (Day 1 to Month 6)
Part A: RSV-A Neutralizing Titers Expressed as GMTs
RSV-A neutralizing titers are given as GMTs and are expressed as ED60.
Time frame: At Day 1 (pre-dose), at Month 1 and Month 6
Part A: RSV-B Neutralizing Titers Expressed as GMTs
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
Time frame: At Day 1 (pre-dose), at Month 1 and Month 6
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GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
North Miami, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Silver Spring, Maryland, United States
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