A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older
NCT Number: NCT06551181
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Interventions: BIOLOGICAL: RSVPreF3 OA investigational vaccine|DRUG: Placebo
Sponsor: GlaxoSmithKline
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-05
Completion Date: 2025-09-12
Locations: GSK Investigational Site, Shanghai, 100027, China|GSK Investigational Site, Shanghai, 200136, China|GSK Investigational Site, Shanghai, 201620, China|GSK Investigational Site, Shanghai, 201901, China|GSK Investigational Site, Shanghai, China|GSK Investigational Site, Espoo, 02230, Finland|GSK Investigational Site, Helsinki, 00290, Finland|GSK Investigational Site, Kokkola, 67100, Finland|GSK Investigational Site, Oulu, 90220, Finland|GSK Investigational Site, Seinajoki, 60100, Finland|GSK Investigational Site, Tampere, 33100, Finland|GSK Investigational Site, Turku, 20520, Finland|GSK Investigational Site, Tokyo, 160-0017, Japan|GSK Investigational Site, Guri-si, 471-701, Korea, Republic of|GSK Investigational Site, Incheon, 400-711, Korea, Republic of|GSK Investigational Site, Seoul, 152-703, Korea, Republic of|GSK Investigational Site, Elblag, 82-300, Poland|GSK Investigational Site, Katowice, 40-282, Poland|GSK Investigational Site, Katowice, 40-600, Poland|GSK Investigational Site, Krakow, 31-501, Poland|GSK Investigational Site, Lodz, 91-363, Poland|GSK Investigational Site, Lublin, 20-362, Poland|GSK Investigational Site, Sochaczew, 96-500, Poland|GSK Investigational Site, Warszawa, 00-215, Poland|GSK Investigational Site, Wroclaw, 50-088, Poland|GSK Investigational Site, Avila, 05071, Spain|GSK Investigational Site, Barcelona, 08036, Spain|GSK Investigational Site, Burgos, 09006, Spain|GSK Investigational Site, Madrid, 28040, Spain|GSK Investigational Site, Salamanca, 37007, Spain|GSK Investigational Site, Valladolid, 47003, Spain|GSK Investigational Site, Belfast, BT7 2EB, United Kingdom|GSK Investigational Site, Blackpool, FY3 7EN, United Kingdom|GSK Investigational Site, Bristol, BS37 4AX, United Kingdom|GSK Investigational Site, Cambridgeshire, CB7 5JD, United Kingdom|GSK Investigational Site, Eynsham, OX29 4QB, United Kingdom|GSK Investigational Site, Hounslow, TW3 3EL, United Kingdom|GSK Investigational Site, Witney, OX28 6JS, United Kingdom

Summary:
The purpose of the current study is to evaluate the immune response of the RSVPreF3 OA investigational vaccine in older adults (OA) at least (\>=) 60 years of age (YOA) in China compared to OA in the same age range to be enrolled from overseas countries that participated in the RSV OA=ADJ-006 (NCT04886596) study, since the vaccine efficacy against lower respiratory tract disease (LRTD) has been demonstrated following a single dose of the RSVPreF3 OA investigational vaccine in the global efficacy study RSV OA=ADJ-006. In addition, the safety (in all participants) , reactogenicity and occurrence of RSV-associated acute respiratory illness (ARI) (in study participants in China only) after administration of the vaccine are also assessed in the current study. No ARI surveillance will be conducted for the overseas participants.

Primary Outcome Measures: RSV-A neutralization titers expressed as geometric mean titers (GMTs) in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group GMT ratios, RSV-A neutralization titers are determined by neutralization assay and expressed as GMTs., At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)|Percentage of participants showing group seroresponse for RSV-A in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group differences, A participant with seroresponse for RSV-A is defined as a participant having at least a 4-fold increase in RSV-A neutralizing titers (1 month post-study intervention administration over pre-study intervention administration \>=4)., At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)|RSV-B neutralization titers expressed as geometric mean titers (GMTs) in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group GMT ratios), RSV-B neutralization titers are determined by neutralization assay and expressed as GMTs., At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)|Percentage of participants showing group seroresponse for RSV-B in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group differences, A participant with seroresponse for RSV-B is defined as a participant having at least a 4-fold increase in RSV-B neutralizing titers (1 month post-study intervention administration over pre-study intervention administration \>=4)., At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
Secondary Outcome Measures: RSV-A neutralization titers expressed as GMTs in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), At Baseline (Day 1), at 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration|RSV-B neutralization titres expressed as GMTs in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), At Baseline (Day 1), at 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration|Percentage of participants showing seroresponse for RSV-A in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), A participant with seroresponse for RSV-A is defined as a participant having at least a 4-fold increase in RSV-A neutralizing titers (1 month post-study intervention administration over pre-study intervention administration \>=4)., At 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration|Percentage of participants showing seroresponse for RSV-B in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), A participant with seroresponse for RSV-B is defined as a participant having at least a 4-fold increase in RSV-B neutralizing titers (1 month post-study intervention administration over pre-study intervention administration \>=4)., At 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration|RSV-A neutralization titers expressed as group GMTs in the immunogenicity subset of RSV OA=ADJ-006 study and in RSV OA vaccine Group (China), At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)|RSV-B neutralization titers expressed as group GMTs in the immunogenicity subset of RSV OA=ADJ-006 study and in RSV OA vaccine Group (China), At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)|Percentage of participants showing seroresponse for RSV-A in the immunogenicity subset of RSV OA=ADJ-006 study and in RSV OA vaccine Group (China), A participant with seroresponse for RSV-A is defined as a participant having at least a 4-fold increase in RSV-A neutralizing titers (1 month post-study intervention administration over pre-study intervention administration \>=4)., At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)|Percentage of participants showing seroresponse for RSV-B in the immunogenicity subset of RSV OA=ADJ-006 study and in RSV OA vaccine Group (China), A participant with seroresponse for RSV-B is defined as a participant having at least a 4-fold increase in RSV-B neutralizing titers (1 month post-study intervention administration over pre-study intervention administration \>=4), At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)|Number of participants with real time polymerase chain reaction (RT-PCR) confirmed RSV-A associated ARI and LRTD in RSV OA vaccine Group (China) and Placebo Group (China), ARI is characterized by the presence of at least 2 respiratory symptoms/signs for at least 24 hours OR at least 1 respiratory symptom/sign + 1 systemic symptom/sign for at least 24 hours. An RT-PCR-confirmed RSV-ARI is defined as an event meeting the case definition of ARI with at least one RSV-positive swab detected by RT-PCR. LRTD is characterized by 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 defined as an event meeting the case definition of LRTD with at least one RSV-positive swab . detected by RT-PCR., From the RSVPreF3 OA investigational vaccine administration (Day 1) to Month 6|Number of participants with RT-PCR confirmed RSV-B associated ARI and LRTD RSV OA vaccine Group (China) and Placebo Group (China), ARI is characterized by the presence of at least 2 respiratory symptoms/signs for at least 24 hours OR at least 1 respiratory symptom/sign + 1 systemic symptom/sign for at least 24 hours. An RT-PCR-confirmed RSV-ARI is defined as an event meeting the case definition of ARI with at least one RSV-positive swab detected by RT-PCR. LRTD is characterized by 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 defined as an event meeting the case definition of LRTD with at least one RSV-positive swab . detected by RT-PCR., From the RSVPreF3 OA investigational vaccine administration (Day 1) to Month 6|Number of participants with solicited administration site events in RSV OA Group (China) and Placebo Group (China), The assessed solicited administration site events are pain, erythema and swelling., Within 7 days after study intervention administration (the day of study intervention administration and the subsequent 6 days)|Number of participants with solicited systemic events in RSV OA Group (China) and Placebo Group (China), The assessed solicited systemic events are fever, headache, myalgia, arthralgia and fatigue., Within 7 days after study interventions (the day of study intervention administration and the subsequent 6 days)|Number of participants with unsolicited adverse events (AEs) in RSV OA Group (China) and Placebo Group (China), An unsolicited AE is 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 must have been communicated by participants who has signed the informed consent., Within 30 days after study interventions (the day of study intervention administration and the subsequent 29 days)|Number of participants with serious adverse events (SAEs) in all study groups, An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity., From the study intervention administration (Day 1) to Month 6|Number of participants with potential immune-mediated disease (pIMDs) in all study groups, pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology., From the study intervention administration (Day 1) to Month 6|Number of participants with SAEs related to study intervention in all study groups, An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity., From the study intervention administration (Day 1) to study end (approximately 6 months post dose administration)|Number of participants with pIMDs related to study interventions in all study groups, pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology., From the RSVPreF3 OA investigational vaccine administration (Day 1) to study end (approximately 6 months post dose administration)|Number of participants with any fatal SAEs in all study groups, An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity., From the RSVPreF3 OA investigational vaccine administration (Day 1) to study end (approximately 6 months post dose administration)