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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06534892




Registration number
NCT06534892
Ethics application status
Date submitted
30/07/2024
Date registered
2/08/2024

Titles & IDs
Public title
An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study
Scientific title
A Phase 3b, Randomized, Open Label, Multicountry, Multi-center, Extension and Crossover Vaccination Study to Evaluate the Immunogenicity and Safety of Different Revaccination Schedules and Persistence of a Single Dose of the RSVPreF3 OA Vaccine in Adults Aged 60 Years and Above Who Participated in the RSV OA=ADJ-006 Study
Secondary ID [1] 0 0
2023-509762-38-00
Secondary ID [2] 0 0
222090
Universal Trial Number (UTN)
Trial acronym
RSV OA=ADJ=012
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 vaccine

Experimental: RSV_PreS4 - Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 4.

Experimental: RSV_PreS5 - Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 5.

No intervention: RSV_1Dose - Participants in this group will not receive any additional dose of RSV PreF3 OA vaccine.

Experimental: Crossover - Participants in this group will receive a single dose of RSVPreF3 OA vaccine.


Treatment: Other: RSVPreF3 OA vaccine
RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group
Timepoint [1] 0 0
At Day 1, Day 31, Month 12, and at Month 24
Primary outcome [2] 0 0
RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group
Timepoint [2] 0 0
At Day 1, Day 31, Month 12, and at Month 24
Primary outcome [3] 0 0
RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV_PreS4 group
Timepoint [3] 0 0
From Day 1 to Day 31, Month 12 and Month 24
Primary outcome [4] 0 0
RSV-B neutralizing titers expressed as MGI in RSV_PreS4 group
Timepoint [4] 0 0
From Day 1 to Day 31, Month 12 and Month 24
Primary outcome [5] 0 0
Percentage of participants with RSV-A neutralizing titers greater than or equal to (>=) cut-off in RSV_PreS4 group
Timepoint [5] 0 0
At Day 1, Day 31, Month 12, and at Month 24
Primary outcome [6] 0 0
Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group
Timepoint [6] 0 0
At Day 1, Day 31, Month 12, and at Month 24
Primary outcome [7] 0 0
Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS4 group
Timepoint [7] 0 0
At Day 31
Primary outcome [8] 0 0
Percentage of participants with SRR for RSVB neutralizing titers in RSV_PreS4 group
Timepoint [8] 0 0
At Day 31
Primary outcome [9] 0 0
RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group
Timepoint [9] 0 0
At Day 1 , Month 12 , Month 13 and at Month 24
Primary outcome [10] 0 0
RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group
Timepoint [10] 0 0
At Day 1, Month 12 , Month 13 and at Month 24
Primary outcome [11] 0 0
RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group
Timepoint [11] 0 0
At Day 1, Month 12 , Month 13 and at Month 24
Primary outcome [12] 0 0
RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group
Timepoint [12] 0 0
From Month 12 to Month 13 and Month 24
Primary outcome [13] 0 0
Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group
Timepoint [13] 0 0
At Day 1, Month 12 , Month 13 and at Month 24
Primary outcome [14] 0 0
Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group
Timepoint [14] 0 0
At Day 1, Month 12 , Month 13 and at Month 24
Primary outcome [15] 0 0
Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS5 group
Timepoint [15] 0 0
At Month 13
Primary outcome [16] 0 0
Percentage of participants with SRR for RSVB neutralizing titers in RSV_PreS5 group
Timepoint [16] 0 0
At Month 13
Secondary outcome [1] 0 0
RSV-A neutralizing titers expressed as GMTs in RSV_1Dose group
Timepoint [1] 0 0
At Day 1, Month 12 and at Month 24
Secondary outcome [2] 0 0
RSV-B neutralizing titers expressed as GMTs in RSV_1Dose group
Timepoint [2] 0 0
At Day 1, Month 12 and at Month 24
Secondary outcome [3] 0 0
Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_1Dose group
Timepoint [3] 0 0
At Day 1, Month 12 and at Month 24
Secondary outcome [4] 0 0
Percentage of participants with RSV-B neutralizing titers >= cut-off in RSV_1Dose group
Timepoint [4] 0 0
At Day 1, Month 12 and at Month 24
Secondary outcome [5] 0 0
Number of participants with unsolicited adverse events
Timepoint [5] 0 0
At Day 30 post vaccination
Secondary outcome [6] 0 0
Number of participants with any serious adverse events (SAEs)
Timepoint [6] 0 0
From day of vaccination and up to 6 months post each vaccine administration
Secondary outcome [7] 0 0
Number of participants with SAEs related to study intervention
Timepoint [7] 0 0
From Day 1 and up to end of study
Secondary outcome [8] 0 0
Number of participants with any potential immune-mediated disease (pIMDs)
Timepoint [8] 0 0
From day of vaccination and up to 6 months post each vaccine administration
Secondary outcome [9] 0 0
Number of participants with pIMDs related to study intervention
Timepoint [9] 0 0
From Day 1 and up to end of study
Secondary outcome [10] 0 0
Number of participants with fatal SAEs
Timepoint [10] 0 0
From Day 1 and up to end of study

Eligibility
Key inclusion criteria
* Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV_1dose group).
* 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, ability to access and utilize a phone or other electronic communications).
* Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
* Participants who are medically stable in the opinion of the investigator at study entry. 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.
Minimum age
60 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 or immunosuppressive/cytotoxic therapy based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
* Hypersensitivity to latex.
* Serious or unstable chronic illness.
* Recurrent or un-controlled neurological disorders or seizures.
* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
* Any other 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.
* Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures.
* Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions.
* Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination.

Prior/Concomitant Therapy:

• Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period. • Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study.

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.

Other

* 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.
* Participation of any study personnel or their immediate dependents, family, or household members.
* Bedridden participants.

Specific exclusion criteria for Crossover group:

• Planned or 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 vaccines which can be administered up to 14 days before or from 14 days after study vaccination. Inactivated seasonal influenza vaccines can be co-administered or administered at any time.

Specific exclusion criteria for RSV_PreS4, RSV_PreS5 and RSV_1Dose groups:

* Planned or 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 vaccines and inactivated seasonal influenza vaccines which can be administered up to 14 days before or from 14 days after study intervention administration.
* Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first study visit or planned administration during the study period.
* Chronic administration of immunosuppressants or other immunemodifying drugs during the period starting 90 days prior to the first study visit or planned administration during the study period. For corticosteroids, this will mean prednisone >= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
1/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
12000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
GSK Investigational Site - Botany
Recruitment hospital [2] 0 0
GSK Investigational Site - Camberwell
Recruitment hospital [3] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [4] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [5] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [6] 0 0
GSK Investigational Site - Murdoch
Recruitment hospital [7] 0 0
GSK Investigational Site - Taringa
Recruitment hospital [8] 0 0
GSK Investigational Site - Tarragindi
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment postcode(s) [3] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
6163 - Murdoch
Recruitment postcode(s) [7] 0 0
4068 - Taringa
Recruitment postcode(s) [8] 0 0
4121 - Tarragindi
Recruitment outside Australia
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Arizona
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Ekaterinburg
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Russian Federation
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Gatchina
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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South Africa
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Country [160] 0 0
United Kingdom
State/province [160] 0 0
Bebington
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Belfast
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Birmingham
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Cardiff
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Corby
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Eynsham
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Glasgow
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Hexham
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Lancashire
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Leamington Spa
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Liverpool
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Manchester
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Orpington
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Oxford
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Peterborough
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Thetford
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Witney

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
GSKClinicalSupportHD@gsk.com
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/NCT06534892