The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,808
RSV/hMPV\_V low dose vaccine administered intramuscularly.
RSV/hMPV\_V medium dose vaccine administered intramuscularly.
RSV/hMPV\_V high dose vaccine administered intramuscularly.
GSK Investigational Site
Botany, New South Wales, Australia
GSK Investigational Site
Camberwell, Victoria, Australia
Number of Participants Reporting Solicited Administration Site Events
Solicited administration site events include pain, redness (erythema) and swelling at administration site.
Time frame: Day 1 to Day 7
Number of Participants Reporting Solicited Systemic Events
Solicited systemic events include fever \[defined as oral or axillary temperature greater than or equal to (\>=) 38.0°C/100.4°F\], headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness).
Time frame: Day 1 to Day 7
Number of Participants Reporting Unsolicited Adverse Events (AEs)
An unsolicited AE is defined as 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 include both serious and non-serious AEs.
Time frame: Day 1 to Day 30
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
MAAE is defined as unscheduled visit to or from healthcare professional for any reason, including emergency room visits.
Time frame: Day 1 to Month 12
Number of Participants Reporting Potential immune-mediated disorders (pIMDs)
pIMDs are a subset of AEs of Special Interest (AESIs) that include autoimmune disorders and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: Day 1 to Month 12
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product.
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RSV/hMPV\_W low dose vaccine administered intramuscularly.
RSV/hMPV\_W medium dose vaccine administered intramuscularly.
RSV/hMPV\_W high dose vaccine administered intramuscularly.
RSV/hMPV\_X low dose vaccine administered intramuscularly.
RSV/hMPV\_X medium dose vaccine administered intramuscularly.
RSV/hMPV\_X high dose vaccine administered intramuscularly.
hMPV\_Y low dose vaccine administered intramuscularly.
hMPV\_Y medium dose vaccine administered intramuscularly.
hMPV\_Y high dose vaccine administered intramuscularly.
hMPV\_Z low dose vaccine administered intramuscularly.
hMPV\_Z medium dose vaccine administered intramuscularly.
hMPV\_Z high dose vaccine administered intramuscularly.
Control vaccine administered intramuscularly.
Placebo administered intramuscularly.
Time frame: Day 1 to study end [Month 24 for OA groups (only the selected formulation group&its comparators), Month 12 for YA groups & OA groups (all other investigational vaccine formulation groups not selected for future clinical development&other comparators)]
Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities
Time frame: At Day 1 (pre-vaccination) in Phase 1 groups
Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities
Time frame: At Day 8 (post-vaccination) in Phase 1 groups
Number of participants with hMPV neutralization titers equal to or above (>=) the assay cut-off value
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
Geometric mean titers (GMTs) of hMPV neutralization titers
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
Mean geometric increase (MGI) of hMPV neutralization titers
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
Seroresponse rate (SRR) against hMPV
SRR is defined as the number of participants having \>=4-fold increase post-vaccination in neutralization titers against hMPV.
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
Number of participants with RSV-A neutralization titers >= assay cut-off value
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
GMTs of RSV-A neutralization titers
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
MGI of RSV-A neutralization titers
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
SRR against RSV-A
SRR is defined as number of participants having \>=4-fold-increase post-vaccination in neutralization titers against RSV-A.
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
Number of participants with RSV-B neutralization titers >= assay cut-off value
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
GMTs of RSV-B neutralization titers
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
MGI of RSV-B neutralization titers
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
SRR against RSV-B
SRR is defined as number of participants having \>=4-fold-increase post-vaccination in neutralization titers against RSV-B.
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
Cell-mediated immunity (CMI) response expressed as frequency of hMPV-specific CD4+ T-cells
Time frame: At Day 1 (pre-vaccination) and Day 31 in Phase 2 OA groups
CMI response expressed as frequency of hMPV-specific CD8+ T-cells
Time frame: At Day 1 (pre-vaccination) and Day 31 in Phase 2 OA groups
Geometric mean fold-increase of the hMPV-specific CD4+ T-cells frequency
Time frame: At Day 31 compared to Day 1 (pre-vaccination) in Phase 2 OA groups
Geometric mean fold-increase of the hMPV-specific CD8+ T-cells frequency
Time frame: At Day 31 compared to Day 1 (pre-vaccination) in Phase 2 OA groups