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 ID: NCT06551181

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2621 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2025-09-15

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.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

RSV OA vaccine Group (China)

Chinese participants receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (Month 6 or last ARI visit/contact, whichever is later).

Group Type: EXPERIMENTAL

RSVPreF3 OA investigational vaccine

Intervention Type: BIOLOGICAL

One dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1.

Placebo Group (China)

Chinese participants receive a single dose of placebo at Day 1 and are followed up until end of study (Month 6 or last ARI visit/contact, whichever is later).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One dose of placebo is administered intramuscularly at Day 1.

RSV OA vaccine Group (Overseas)

Overseas participants receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (Month 6).

Group Type: EXPERIMENTAL

RSVPreF3 OA investigational vaccine

Intervention Type: BIOLOGICAL

One dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1.

Interventions

RSVPreF3 OA investigational vaccine

One dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1.

Intervention Type: BIOLOGICAL

Placebo

One dose of placebo is administered intramuscularly at Day 1.

Intervention Type: DRUG

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).

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Shanghai, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Kokkola, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Seinäjoki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Turku, , Finland

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Elblag, , Poland

GSK Investigational Site

Katowice, , Poland

GSK Investigational Site

Katowice, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Lublin, , Poland

GSK Investigational Site

Sochaczew, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Guri-si, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Ávila, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Burgos, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Salamanca, , Spain

GSK Investigational Site

Valladolid, , Spain

GSK Investigational Site

Belfast, , United Kingdom

GSK Investigational Site

Blackpool, , United Kingdom

GSK Investigational Site

Bristol, , United Kingdom

GSK Investigational Site

Cambridgeshire, , United Kingdom

GSK Investigational Site

Eynsham, , United Kingdom

GSK Investigational Site

Hounslow, , United Kingdom

GSK Investigational Site

Witney, , United Kingdom

Countries

China; Finland; Japan; Poland; South Korea; Spain; United Kingdom

Other Identifiers

2023-509455-13-00

Identifier Type: OTHER

Identifier Source: secondary_id

219815

Identifier Type: -

Identifier Source: org_study_id