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

NCT06551181 | Completed Phase 3 Results

• 2 other identifiers: 2198152023-509455-13-00
• Study Type: interventional
• Target: 2,620
• Locations: 7 countries
• Sites: 40

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

Keywords

Respiratory syncytial virus (RSV); Older adults; Acute respiratory illness (ARI); Lower respiratory tract disease (LRTD); Immune response; Efficacy study; Safety study

Outcome Measures

Primary Outcomes (4)

• RSV-A Neutralizing Titers Expressed as Adjusted Geometric Mean Titers (GMTs) at 1 Month Post RSVPreF3 OA Vaccination

  RSV-A neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate.

  At Day 31

• Percentage of Participants With Seroresponse for RSV-A Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination

  Seroresponse was defined as at least a 4 fold (≥4) increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration).

  At Day 31 compared to baseline (Day 1)

• RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination

  RSV-B neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate.

  At Day 31

• Percentage of Participants With Seroresponse for RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination

  At Day 31 compared to baseline (Day 1)

Secondary Outcomes (20)

• RSV-A Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination

  At Day 1 (baseline) and Day 31 (1 month post RSVPreF3 OA vaccination)

• RSV-B Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination

  At Day 1 (baseline) and Day 31 (1 month post RSVPreF3 OA vaccination)

• RSV-A and RSV-B Neutralizing Titers Expressed as Unadjusted GMTs at 6 Months Post RSVPreF3 OA Vaccination

  At Day 181 (6 months post RSVPreF3 OA vaccination)

• Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination

  At Day 31 compared to baseline (Day 1)

• Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 6 Months Post RSVPreF3 OA Vaccination

  At Day 181 compared to baseline (Day 1)

Study Arms (3)

RSV OA vaccine Group (Overseas)

EXPERIMENTAL

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

Biological: RSVPreF3 OA investigational vaccine

RSV OA vaccine Group (China)

EXPERIMENTAL

Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).

Biological: RSVPreF3 OA investigational vaccine

Placebo Group (China)

EXPERIMENTAL

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

Drug: Placebo (Saline solution)

Interventions

RSVPreF3 OA investigational vaccine BIOLOGICAL

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

RSV OA vaccine Group (China); RSV OA vaccine Group (Overseas)

Placebo (Saline solution) DRUG

One dose of placebo is administered intramuscularly at Day 1.

Placebo Group (China)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (40)

GSK Investigational Site

Shanghai, Putuo, 200065, China

Location

GSK Investigational Site

Shanghai, Putuo, China

Location

GSK Investigational Site

Shanghai, Shanghai Municipality, China

Location

GSK Investigational Site

Shanghai, 200136, China

Location

GSK Investigational Site

Shanghai, 201620, China

Location

GSK Investigational Site

Shanghai, 201901, China

Location

GSK Investigational Site

Shanghai, China

Location

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00290, Finland

Location

GSK Investigational Site

Kokkola, 67100, Finland

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Tokyo, 160-0017, Japan

Location

GSK Investigational Site

Elblag, 82-300, Poland

Location

GSK Investigational Site

Katowice, 40-282, Poland

Location

GSK Investigational Site

Katowice, 40-600, Poland

Location

GSK Investigational Site

Krakow, 31-501, Poland

Location

GSK Investigational Site

Lodz, 91-363, Poland

Location

GSK Investigational Site

Lublin, 20-362, Poland

Location

GSK Investigational Site

Sochaczew, 96-500, Poland

Location

GSK Investigational Site

Warsaw, 00-215, Poland

Location

GSK Investigational Site

Wroclaw, 50-088, Poland

Location

GSK Investigational Site

Guri-si, 471-701, South Korea

Location

GSK Investigational Site

Incheon, 400-711, South Korea

Location

GSK Investigational Site

Seoul, 152-703, South Korea

Location

GSK Investigational Site

Ávila, 05071, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Burgos, 09006, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Salamanca, 37007, Spain

Location

GSK Investigational Site

Valladolid, 47003, Spain

Location

GSK Investigational Site

Belfast, BT7 2EB, United Kingdom

Location

GSK Investigational Site

Blackpool, FY3 7EN, United Kingdom

Location

GSK Investigational Site

Bristol, BS37 4AX, United Kingdom

Location

GSK Investigational Site

Cambridgeshire, CB7 5JD, United Kingdom

Location

GSK Investigational Site

Eynsham, OX29 4QB, United Kingdom

Location

GSK Investigational Site

Hounslow, TW3 3EL, United Kingdom

Location

GSK Investigational Site

Witney, OX28 6JS, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data from study participants in China is collected in an observer-blind manner. The study is open labelled for overseas participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: August 5, 2024
• Primary Completion: April 24, 2025
• Study Completion: September 15, 2025
• Last Updated: May 19, 2026
• Results First Posted: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

GB (7); PL (9); ES (6); FI (7); JP (1); CN (7); KR (3)