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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06389487




Registration number
NCT06389487
Ethics application status
Date submitted
24/04/2024
Date registered
29/04/2024

Titles & IDs
Public title
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above
Scientific title
A Phase 3b, Open-label Study to Evaluate the Non-inferiority of the Immune Response and to Evaluate the Safety of the RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults >=60 Years of Age
Secondary ID [1] 0 0
2023-510190-34-00
Secondary ID [2] 0 0
222253
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - RSVPreF3 OA investigational vaccine

Experimental: Part A: RSV-A-AIR Group - Adult participants, 18-49 YOA, at increased risk (AIR) for RSV disease, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).

Experimental: Part A: RSV-OA Group - Older adults (OA) participants, \>=60 YOA, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).

Experimental: Part B: RSV-A-AIR Group - Adult participants, 18-49 YOA, at increased risk (AIR) for RSV disease, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).


Treatment: Other: RSVPreF3 OA investigational vaccine
1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1;
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: RSV-A neutralizing titers expressed as group Geometric Mean Titers (GMTs) (RSV-OA over RSV-A-AIR)
Timepoint [1] 0 0
At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration
Primary outcome [2] 0 0
Part A: Seroresponse rate (SRR) in RSV-A neutralizing titers
Timepoint [2] 0 0
At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration compared to baseline (Day 1)
Primary outcome [3] 0 0
Part A: RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR)
Timepoint [3] 0 0
At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration
Primary outcome [4] 0 0
Part A: SRR in RSV-B neutralizing titers
Timepoint [4] 0 0
At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration compared to baseline (Day 1)
Secondary outcome [1] 0 0
Part A and B: Percentage of participants reporting solicited administration site events
Timepoint [1] 0 0
During the 4-day follow up period after vaccination (vaccine administered at Day 1)
Secondary outcome [2] 0 0
Part A and B: Percentage of participants reporting solicited systemic events
Timepoint [2] 0 0
During the 4-day follow up period after vaccination (vaccine administered at Day 1)
Secondary outcome [3] 0 0
Part A and B: Percentage of participants reporting unsolicited adverse events (AEs)
Timepoint [3] 0 0
During the 30-day follow up period after vaccination (vaccine administered at Day 1)
Secondary outcome [4] 0 0
Part A and B: Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs
Timepoint [4] 0 0
From study intervention administration (Day 1) up to study end (Month 6 after study intervention administration)
Secondary outcome [5] 0 0
Part A and B: Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF)
Timepoint [5] 0 0
From study intervention administration (Day 1) up to study end (Month 6 after study intervention administration)
Secondary outcome [6] 0 0
Part A: RSV-A neutralizing titers expressed as GMTs
Timepoint [6] 0 0
At pre-study intervention administration (Day 1), at Month 1 and Month 6 post-study intervention administration
Secondary outcome [7] 0 0
Part A: RSV-B neutralizing titers expressed as GMTs
Timepoint [7] 0 0
At pre-study intervention administration (Day 1), at Month 1 and Month 6 post-study intervention administration

Eligibility
Key inclusion criteria
* Participants and/or participant's parent(s)/ Legally acceptable representative (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications).
* Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.

Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than the legal age prior to performance of any study-specific procedure.

Specific inclusion criteria for all participants in Cohort 1 and Cohort 3 (RSV-A-AIR Group) • A male or female participant 18-49 YOA at the time of the study intervention administration.

* Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator:

* Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long term medication:

o Chronic obstructive pulmonary disease (COPD)

o Asthma

o Cystic fibrosis

o Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis

o Chronic heart failure:

o Pre-existing Coronary Artery Disease (CAD) (CAD not otherwise specified)
* Cardiac arrhythmia
* Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months
* Other diseases at increased risk for RSV disease:

* Chronic kidney disease
* Chronic moderate to severe liver disease
* Neurologic or neuromuscular conditions
* Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as premenarche, hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.
* Female participants of childbearing potential may be enrolled in the study, if the participant:

* has practiced adequate contraception from 1 month prior to study intervention administration, and
* has a negative pregnancy test on the day of study prior to intervention administration, and
* has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration.

Specific inclusion criteria for all participants in Cohort 2 (RSV-OA Group):

• A male or female participant >=60 YOA at the time of the study intervention administration.

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 medically stable by the investigator.

• Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical conditions

* 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).
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
* Unstable chronic illness.
* Any history of dementia or any medical condition that moderately or severely impairs cognition.
* Recurrent 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 study site visits). Study participants may decide to assign a caregiver to help them complete the study procedures.
* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).
* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
* 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

* Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 3, Month 6).
* 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 the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.
* Previous vaccination with any RSV vaccine, including investigational RSV vaccines.
* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the End-of-study (EOS).

* Up to 3 months prior to the study intervention administration:

* For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed
* Administration of immunoglobulins and/or any blood products or plasma derivatives
* Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., Tumor Necrosis Factor (TNF)-inhibitors), monoclonal antibodies, antitumoral medication.

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 vaccine/product (drug or invasive medical device).

Other exclusions:

Other exclusions for all participants:

* 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 period that will prohibit participating in the study until study end.
* Participation of any study personnel or their immediate dependents, family, or household members.

Other exclusions for Cohort 1 and Cohort 3:

* Pregnant or lactating female participant.
* Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/04/2025
Actual
Sample size
Target
1450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [2] 0 0
GSK Investigational Site - Tarragindi
Recruitment hospital [3] 0 0
GSK Investigational Site - North Melbourne
Recruitment hospital [4] 0 0
GSK Investigational Site - St Albans
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4121 - Tarragindi
Recruitment postcode(s) [3] 0 0
3051 - North Melbourne
Recruitment postcode(s) [4] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Nova Scotia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Canada
State/province [16] 0 0
Québec
Country [17] 0 0
Germany
State/province [17] 0 0
Baden Wuerttemberg
Country [18] 0 0
Germany
State/province [18] 0 0
Bayern
Country [19] 0 0
Germany
State/province [19] 0 0
Nordrhein-Westfalen
Country [20] 0 0
Germany
State/province [20] 0 0
Rheinland-Pfalz
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Japan
State/province [22] 0 0
Ibaraki
Country [23] 0 0
Japan
State/province [23] 0 0
Kanagawa
Country [24] 0 0
Japan
State/province [24] 0 0
Tokyo
Country [25] 0 0
South Africa
State/province [25] 0 0
Gauteng
Country [26] 0 0
South Africa
State/province [26] 0 0
Bellville
Country [27] 0 0
South Africa
State/province [27] 0 0
Mowbray
Country [28] 0 0
South Africa
State/province [28] 0 0
Newton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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 terminated asset(s) across all indications.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06389487