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

GlaxoSmithKline2,621 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

2,621

Conditions

Respiratory Syncytial Virus Infections

Interventions

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult male or female of ≥60 YOA at the time of study intervention administration, who live in the community dwelling (CD participants). * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only), ability to access and utilize a phone or other electronic communications). * Participants who are medically stable in the opinion of the investigator at the time of vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable. * Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study specific procedure. Exclusion Criteria: Medical Conditions: * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). * Any clinical conditions for which serum samples would be prohibited for transfer to local central lab for testing. These clinical conditions include hepatitis B, hepatitis C, HIV and Syphilis based on medical history and physical examination (all participants) and laboratory screening tests (overseas participants). * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required). * Any history of dementia or any medical condition that moderately or severely impairs cognition. * Recurrent history or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only). * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year). * Serious or unstable chronic illness. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant Therapy: * Previous vaccination with RSV vaccine. * Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the study period. * Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID-19 and inactivated/subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study intervention. * Administration of long-acting immune-modifying drugs or planned administration at any time during the study period (e.g., infliximab). * Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration or planned administration during the study period. * Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the study intervention administration or planned administration during the study period. For corticosteroids, this will mean prednisone \>=20 mg/day, or equivalent. Inhaled and topical steroids are allowed. Prior/Concurrent Clinical Study Experience: • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device). Other Exclusion Criteria: * History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. * Bedridden participants. * Planned move during the study conduct that prohibits participation until study end. * Participation of any study personnel or their immediate dependents, family, or household members.

Locations (40)

GSK Investigational Site

Shanghai, Putuo, China

GSK Investigational Site

Shanghai, Putuo, China

GSK Investigational Site

Shanghai, Shanghai Municipality, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)

Secondary Outcomes

RSV-A neutralization titers expressed as GMTs in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: From the RSVPreF3 OA investigational vaccine administration (Day 1) to study end (approximately 6 months post dose administration)