The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of RSV-LRTD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
751
1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly on Day 1 to participants in OA-RSV and Adults-AIR-RSV groups.
1 dose of placebo (saline solution) administered intramuscularly on Day 1 to participants in OA-Placebo and Adults-AIR-Placebo groups.
GSK Investigational Site
Ahmedabad, India
GSK Investigational Site
Ahmedabad, India
GSK Investigational Site
Aligarh, India
GSK Investigational Site
Bangalore, India
GSK Investigational Site
Belagavi, India
GSK Investigational Site
Darjeeling, India
GSK Investigational Site
Delhi, India
GSK Investigational Site
Kanpur, India
GSK Investigational Site
Kelambākkam, India
GSK Investigational Site
Kochi, India
...and 4 more locations
RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs)
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).
Time frame: At Day 1 (pre-study intervention administration)
RSV-A neutralizing titers expressed as GMTs
RSV-A neutralizing titers are given as GMTs and are expressed as ED60.
Time frame: At Day 31 (1 month post-study intervention administration)
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-study intervention administration)
RSV-B neutralizing titers expressed as GMTs
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
Time frame: At Day 31 (1 month post-study intervention administration)
Number of participants reporting any solicited administration site events
Assessed solicited administration site adverse events (AEs) were redness (erythema), pain and swelling at administration site. Any = occurrence of the AE regardless of intensity grade or relationship to the study interventions.
Time frame: Day 1 (day of administration) to Day 4
Number of participants reporting any solicited systemic events
Assessed solicited systemic events were arthralgia (joint pain), fatigue (tiredness), fever (pyrexia), headache, and myalgia (muscle pain). 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 or relationship to the study interventions.
Time frame: Day 1 (day of administration) to Day 4
Number of participants reporting any unsolicited AEs
An unsolicited AE was 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, and potential immune-mediated diseases (pIMDs). Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Time frame: Day 1 to Day 30
Number of participants reporting any serious adverse events (SAEs)
An SAE was 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 = occurrence of the event regardless of the intensity grade or relation to the study intervention.
Time frame: From Day 1 up to data lock point of primary analysis (median follow-up: 176 days)
Number of participants reporting any SAEs
Data not available at the time of initial results posting will be updated at the final results disclosure stage.
Time frame: From Day 1 up to study end (approximately 6 months post study intervention administration)
Number of participants reporting any pIMDs
pIMDs were a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any = occurrence of the event regardless of the intensity grade or relation to the study intervention.
Time frame: From Day 1 up to data lock point of primary analysis (median follow-up: 176 days)
Number of participants reporting any pIMDs
Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Time frame: From Day 1 up to study end (approximately 6 months post study intervention administration)
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