Clinical trial NCT06551181: 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
Official title: A Phase 3, Randomized, Controlled, Partially Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety and the Occurrence of RSV Associated Respiratory Tract Illness After Administration of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Older
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus (RSV)
Older adults
Acute respiratory illness (ARI)
Lower respiratory tract disease (LRTD)
Immune response
Efficacy study
Safety study
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2024-08-13
Enrollment: 2600
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
measure: 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
timeFrame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
measure: 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)
timeFrame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
measure: 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
timeFrame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
Secondary outcomes:
measure: RSV-A neutralization titers expressed as GMTs in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China)
timeFrame: At Baseline (Day 1), at 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration
measure: RSV-B neutralization titres expressed as GMTs in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China)
timeFrame: At Baseline (Day 1), at 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration
measure: Percentage of participants showing seroresponse for RSV-A in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China)
timeFrame: At 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration
measure: Percentage of participants showing seroresponse for RSV-B in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China)
timeFrame: At 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration
measure: 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)
timeFrame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
measure: 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)
timeFrame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
measure: 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)
timeFrame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
measure: 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)
timeFrame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
measure: 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)
timeFrame: From the RSVPreF3 OA investigational vaccine administration (Day 1) to Month 6
measure: Number of participants with RT-PCR confirmed RSV-B associated ARI and LRTD RSV OA vaccine Group (China) and Placebo Group (China)
timeFrame: From the RSVPreF3 OA investigational vaccine administration (Day 1) to Month 6
measure: Number of participants with solicited administration site events in RSV OA Group (China) and Placebo Group (China)
timeFrame: Within 7 days after study intervention administration (the day of study intervention administration and the subsequent 6 days)
measure: Number of participants with solicited systemic events in RSV OA Group (China) and Placebo Group (China)
timeFrame: Within 7 days after study interventions (the day of study intervention administration and the subsequent 6 days)
measure: Number of participants with unsolicited adverse events (AEs) in RSV OA Group (China) and Placebo Group (China)
timeFrame: Within 30 days after study interventions (the day of study intervention administration and the subsequent 29 days)
measure: Number of participants with serious adverse events (SAEs) in all study groups
timeFrame: From the study intervention administration (Day 1) to Month 6
measure: Number of participants with potential immune-mediated disease (pIMDs) in all study groups
timeFrame: From the study intervention administration (Day 1) to Month 6
measure: Number of participants with SAEs related to study intervention in all study groups
timeFrame: From the study intervention administration (Day 1) to study end (approximately 6 months post dose administration)
measure: Number of participants with pIMDs related to study interventions in all study groups
timeFrame: From the RSVPreF3 OA investigational vaccine administration (Day 1) to study end (approximately 6 months post dose administration)
measure: Number of participants with any fatal SAEs in all study groups
timeFrame: From the RSVPreF3 OA investigational vaccine administration (Day 1) to study end (approximately 6 months post dose administration)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Kokkola
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Guri-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Elblag
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Sochaczew
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Avila
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Burgos
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Salamanca
country: Spain
facility: GSK Investigational Site
city: Valladolid
country: Spain
facility: GSK Investigational Site
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Cambridgeshire
country: United Kingdom
facility: GSK Investigational Site
city: Eynsham
country: United Kingdom
facility: GSK Investigational Site
city: Hounslow
country: United Kingdom
facility: GSK Investigational Site
city: Witney
country: United Kingdom
facility: GSK Investigational Site
Study officials:
References: