The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
750
1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1 dose of saline solution administered intramuscularly in the deltoid region of the non-dominant arm.
GSK Investigational Site
Beijing, Beijing Municipality, China
GSK Investigational Site
Xiangtan, Hunan, China
GSK Investigational Site
Nanjing, Jiangsu, China
GSK Investigational Site
Chengdu, Sichuan, China
GSK Investigational Site
Chengdu, China
GSK Investigational Site
Chongqing, China
GSK Investigational Site
Chongqing, China
GSK Investigational Site
Guangzhou, China
GSK Investigational Site
Guangzhou, China
GSK Investigational Site
Jiujiang, China
...and 5 more locations
RSV-A neutralizing titers expressed as group Geometric Mean Titers (GMTs)
The serum neutralizing titers are expressed in Estimated Dilution (ED60). The group GMT ratio will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) over RSV AIR (from the current study).
Time frame: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)
RSV-A neutralizing titers expressed as group Seroresponse rate (SRR)
The SRR is defined as the proportion of participants having a 4-fold increase in neutralizing titers. The group SRR difference will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) minus RSV AIR (from the current study).
Time frame: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)
RSV-B neutralizing titers expressed as group GMTs
The serum neutralizing titers are expressed in ED60. The group GMT ratio will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) over RSV AIR (from the current study).
Time frame: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)
RSV-B neutralizing titers expressed as group SRR
The group SRR difference will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) minus RSV AIR (from the current study).
Time frame: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)
RSV-A and RSV-B neutralizing titers expressed as group GMTs
The serum neutralizing titers are expressed in ED60. The group GMT ratio will be evaluated for RSV-OA Chinese group (from RSV OA-ADJ-021 study) over RSV AIR (from the current study).
Time frame: At Day 31 and at Month 6 (i.e., 1 month and 6 months after RSVPreF3 OA investigational vaccine administration)
RSV-A and RSV-B neutralizing titers expressed as group SRR
The group SRR difference will be evaluated for RSV-OA Chinese group (from RSV OA-ADJ-021 study) minus RSV AIR (from the current study).
Time frame: At Day 31 and at Month 6 (i.e., 1 month and 6 months after RSVPreF3 OA investigational vaccine administration)
Number of participants with RT-PCR-confirmed RSV A and/or B-associated acute respiratory illness (ARI) and lower respiratory tract disease (LRTD), assessed for all groups of the current study
An ARI is defined as the presence of at least 2 respiratory symptoms/signs for at least 24 hours; or at least 1 respiratory symptom/sign and 1 systemic symptom/sign for at least 24 hours. An RT-PCR-confirmed RSV-ARI is an event meeting the case definition of ARI with at least one RSV-positive swab detected by RT-PCR. A LRTD is defined as the presence of at least 2 lower respiratory symptoms/signs for at least 24 hours including at least 1 lower respiratory sign; or at least 3 lower respiratory symptoms for at least 24 hours. An RT-PCR-confirmed RSV-LRTD is an event meeting the case definition of LRTD with at least one RSV-positive swab detected by RT-PCR.
Time frame: Day 1 to Month 6 of the current study
Duration of RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD episodes, assessed for all the groups of the current study
Time frame: Day 1 to Month 6 of the current study
Number of participants reporting symptoms/signs of RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD, assessed for all the groups of the current study
Time frame: Day 1 to Month 6 of the current study
Number of participants with RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD by severity, assessed for all the groups of the current study
Time frame: Day 1 to Month 6 of the current study
Number of participants with RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD by frailty status, assessed for all the groups of the current study
Time frame: Day 1 to Month 6 of the current study
Number of participants with each solicited administration site event assessed for all the groups of the current study
Solicited administration site event are pain, erythema and swelling.
Time frame: Day 1 to Day 7 of the current study
Number of participants with each solicited systemic event assessed for all the groups of the current study
Solicited systemic events are fever, myalgia (muscle pain), arthralgia (joint pain), headache and fatigue (tiredness). Fever is defined as a temperature of more than or equal to (\>=) 38.0 degrees Celsius (°C).
Time frame: Day 1 to Day 7 of the current study
Number of participants with unsolicited adverse events (AEs) assessed for all the groups of the current study
An unsolicited AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention 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.
Time frame: Day 1 to Day 30 of the current study
Number of participants with serious adverse events (SAEs) assessed for all the groups of the current study
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient 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, abnormal pregnancy outcomes, is a suspected transmission of any infectious agent via an authorized medicinal product. or any other situation considered as such by the investigator.
Time frame: Day 1 up to study end (Month 6) of the current study
Number of participants with potential immune-mediated disease (pIMDs) assessed for all the groups of the current study
PIMDs are a subset of adverse events 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: Day 1 up to study end (Month 6) of the current study
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