The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational vaccine administered as a single dose in adults ≥ 60 years of age (YOA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
770
One dose of a unique combination of the RSVPreF3 antigen lots (Lot 1, Lot 2 or Lot 3) and extemporaneously reconstituted with AS01E adjuvant lots (Lot A, Lot B and Lot C), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1.
GSK Investigational Site
Waterbury, Connecticut, United States
GSK Investigational Site
Brooksville, Florida, United States
RSVPreF3 Specific Immunoglobin (Ig)G Antibody Concentrations Expressed as Group Geometric Mean Concentration (GMC)
Enzyme-linked immunosorbent assay (ELISA) was used to assess the concentrations of IgG antibodies against RSV PreF3 in serum samples.
Time frame: At 30 days post-vaccination (Day 31)
RSVPreF3 Specific IgG Antibody Concentrations Expressed as Mean Geometric Increase (MGI)
MGI was defined as the geometric mean of the within participant ratios of the post-vaccination RSV PreF3 IgG concentration over the pre-vaccination RSV PreF3 IgG concentration.
Time frame: At 30 days post-vaccination (Day 31)
Percentage of Participants Reporting Solicited Administration Site Events
Solicited administration site adverse events (AEs) assessed were erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade.
Time frame: Within 4 days (the day of vaccination and 3 subsequent days) after study intervention administration
Percentage of Participants Reporting Solicited Systemic Events
Solicited systemic events assessed were arthralgia, fatigue, fever \[defined as temperature equal to or above (\>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F)}, headache and myalgia. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
Time frame: Within 4 days (the day of vaccination and 3 subsequent days) after study intervention administration
Percentage of Participants Reporting at Least One Unsolicited Adverse Event
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Unsolicited AEs include serious, non-serious AEs and potential immune-mediated diseases (pIMDs).
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GSK Investigational Site
Immokalee, Florida, United States
GSK Investigational Site
Buford, Georgia, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Petal, Mississippi, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Greensboro, North Carolina, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Vancouver, British Columbia, Canada
...and 9 more locations
Time frame: Within 30 days (the day of vaccination and 29 subsequent days) after study intervention administration
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)
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. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Time frame: From Day 1 up to study end (6 months after vaccination)
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: From Day 1 up to study end (6 months after vaccination)