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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04886596




Registration number
NCT04886596
Ethics application status
Date submitted
29/04/2021
Date registered
14/05/2021

Titles & IDs
Public title
Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Scientific title
A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above
Secondary ID [1] 0 0
2020-000753-28
Secondary ID [2] 0 0
212494
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 - Placebo
Treatment: Other - RSVPreF3 OA vaccine

Experimental: RSVPreF3 Group - Participants in this group received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants were re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine before Season 2; participants in the other receiving a dose of placebo before Season 2.

Placebo comparator: Placebo Group - Participants in this group received 1 dose of placebo at Day 1 and received an additional dose of placebo before Season 2.


Treatment: Other: Placebo
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 and before Season 2 to the Placebo Group, and before Season 2 to the participants of the RSVPreF3 Group, that are re-randomized to the RSV_1 dose group.

Treatment: Other: RSVPreF3 OA vaccine
RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at Day 1 in the RSVPreF3 group, and before Season 2 to the participants of the RSVPreF3 group that are re-randomized to the RSV_annual group.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine
Timepoint [1] 0 0
From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [assessed approximately 6.7 months per participant]
Secondary outcome [1] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Timepoint [1] 0 0
From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemishpere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [2] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Timepoint [2] 0 0
From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [3] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Timepoint [3] 0 0
From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 3 years in the NH and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [4] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Timepoint [4] 0 0
From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
Secondary outcome [5] 0 0
Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Timepoint [5] 0 0
From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
Secondary outcome [6] 0 0
Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Timepoint [6] 0 0
From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
Secondary outcome [7] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [7] 0 0
From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [8] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [8] 0 0
From Day 15 post first-vaccination or start of the RSV season to the first occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season
Secondary outcome [9] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [9] 0 0
From Day 15 post first and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination)
Secondary outcome [10] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [10] 0 0
From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [11] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [11] 0 0
From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [12] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [12] 0 0
From Day 15 post first and each revaccination dose to the first occurrence of RSV severe LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [13] 0 0
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Acute Respiratory Illness (ARI) Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [13] 0 0
From Day 15 post first and each revaccination dose to first occurrence of RSV ARI (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [14] 0 0
Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [14] 0 0
From Day 15 post first vaccination up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Secondary outcome [15] 0 0
Number of Hospitalizations Due to Respiratory Diseases or Due to a Complication Related to Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [15] 0 0
From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Secondary outcome [16] 0 0
Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [16] 0 0
From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Secondary outcome [17] 0 0
Number of Complications Related to ARI and RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [17] 0 0
From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Secondary outcome [18] 0 0
Maximum Influenza Patient- Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [18] 0 0
During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Secondary outcome [19] 0 0
Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [19] 0 0
During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Secondary outcome [20] 0 0
EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [20] 0 0
At the ARI visit (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Secondary outcome [21] 0 0
Short Form-12 (SF-12) Physical Functioning Score for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Timepoint [21] 0 0
At the ARI visit (assessed from one-month post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Secondary outcome [22] 0 0
Duration of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes
Timepoint [22] 0 0
Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [23] 0 0
Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B ARI Episodes
Timepoint [23] 0 0
Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [24] 0 0
Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B LRTD Episodes
Timepoint [24] 0 0
Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [25] 0 0
Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity
Timepoint [25] 0 0
Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Secondary outcome [26] 0 0
RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations
Timepoint [26] 0 0
At Day 1 (Pre-Dose 1) and Day 31
Secondary outcome [27] 0 0
RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations
Timepoint [27] 0 0
Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)
Secondary outcome [28] 0 0
RSV A Neutralizing Antibody Titers
Timepoint [28] 0 0
At Day 1 (Pre-Dose 1) and Day 31
Secondary outcome [29] 0 0
RSV A Neutralizing Antibody Titers
Timepoint [29] 0 0
Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)
Secondary outcome [30] 0 0
RSV B Neutralizing Antibody Titers
Timepoint [30] 0 0
At Day 1 (Pre-Dose 1) and Day 31
Secondary outcome [31] 0 0
RSV B Neutralizing Antibody Titers
Timepoint [31] 0 0
Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)
Secondary outcome [32] 0 0
Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Timepoint [32] 0 0
During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
Secondary outcome [33] 0 0
Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Timepoint [33] 0 0
During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)
Secondary outcome [34] 0 0
Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Timepoint [34] 0 0
During the 4-day follow up period after the third vaccination (administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))
Secondary outcome [35] 0 0
Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
Timepoint [35] 0 0
During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
Secondary outcome [36] 0 0
Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
Timepoint [36] 0 0
During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)
Secondary outcome [37] 0 0
Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
Timepoint [37] 0 0
During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere)
Secondary outcome [38] 0 0
Number of Days With Solicited Administration Site Adverse Events
Timepoint [38] 0 0
During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
Secondary outcome [39] 0 0
Number of Days With Solicited Administration Site Adverse Events
Timepoint [39] 0 0
During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)
Secondary outcome [40] 0 0
Number of Days With Solicited Administration Site Adverse Events
Timepoint [40] 0 0
During the 4-day follow up period after third vaccination (vaccine administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))
Secondary outcome [41] 0 0
Number of Days With Solicited Systemic Adverse Events
Timepoint [41] 0 0
During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
Secondary outcome [42] 0 0
Number of Days With Solicited Systemic Adverse Events
Timepoint [42] 0 0
During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)
Secondary outcome [43] 0 0
Number of Days With Solicited Systemic Adverse Events
Timepoint [43] 0 0
During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Secondary outcome [44] 0 0
Number of Participants With Any Unsolicited AEs
Timepoint [44] 0 0
During the 30-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
Secondary outcome [45] 0 0
Number of Participants With Any Unsolicited AEs
Timepoint [45] 0 0
During the 30-day follow up period after second vaccination (vaccine administered pre-season 2)
Secondary outcome [46] 0 0
Number of Participants With Any Unsolicited AEs
Timepoint [46] 0 0
During the 30-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Secondary outcome [47] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [47] 0 0
From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Secondary outcome [48] 0 0
Number of Participants With Potential Immune Mediated Diseases (pIMDs)
Timepoint [48] 0 0
From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Secondary outcome [49] 0 0
Number of Participants With Related SAEs and Fatal SAEs
Timepoint [49] 0 0
From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Secondary outcome [50] 0 0
Number of Participants With Related pIMDs
Timepoint [50] 0 0
From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])

Eligibility
Key inclusion criteria
* A male or female = 60 YOA at the time of first vaccination, who live in the community (community dwelling participants) or in a long-term care facility (LTCF participants).
* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant's health status while answering diaries and/or questionnaires or make decisions on behalf of the participant

* 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 the time of first 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.
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 (no laboratory testing required).
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Hypersensitivity to latex.
* Serious or unstable chronic illness.
* Any history of dementia or any medical condition that moderately or severely impairs cognition.

Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant.

* Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active 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.
* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

Prior/Concomitant therapy

* Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study vaccine administration, or 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 each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination.
* Previous vaccination with an RSV vaccine.
* 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 vaccine 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 first study vaccine 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 vaccine/product (drug or medical device).

Other exclusions

* 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 trial until study end. This includes:

* Planned move during the study period to another LTCF that will prohibit participation in the trial until study end.
* Planned move from the community to a LTCF that will prohibit participation in the trial until study end.
* Participation of any study personnel or their immediate dependants, family, or household members.
* Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons* covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit.

* RSV seasons are from October to April in NH and from March to September in SH.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/06/2024
Actual
Sample size
Target
Accrual to date
Final
26668
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
GSK Investigational Site - Kogarah
Recruitment hospital [4] 0 0
GSK Investigational Site - Morayfield
Recruitment hospital [5] 0 0
GSK Investigational Site - Taringa
Recruitment hospital [6] 0 0
GSK Investigational Site - Tarragindi
Recruitment hospital [7] 0 0
GSK Investigational Site - Camberwell
Recruitment hospital [8] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [9] 0 0
GSK Investigational Site - Spearwood
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4506 - Morayfield
Recruitment postcode(s) [5] 0 0
4068 - Taringa
Recruitment postcode(s) [6] 0 0
4121 - Tarragindi
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
Belgium
State/province [24] 0 0
Aalst
Country [25] 0 0
Belgium
State/province [25] 0 0
Alken
Country [26] 0 0
Belgium
State/province [26] 0 0
Edegem
Country [27] 0 0
Belgium
State/province [27] 0 0
Erpent
Country [28] 0 0
Belgium
State/province [28] 0 0
Genk
Country [29] 0 0
Belgium
State/province [29] 0 0
Gent
Country [30] 0 0
Belgium
State/province [30] 0 0
Gozée
Country [31] 0 0
Belgium
State/province [31] 0 0
Gribomont
Country [32] 0 0
Belgium
State/province [32] 0 0
Halen
Country [33] 0 0
Belgium
State/province [33] 0 0
Hasselt
Country [34] 0 0
Belgium
State/province [34] 0 0
Ieper
Country [35] 0 0
Belgium
State/province [35] 0 0
Kluisbergen
Country [36] 0 0
Belgium
State/province [36] 0 0
Mechelen
Country [37] 0 0
Belgium
State/province [37] 0 0
Stoumont
Country [38] 0 0
Belgium
State/province [38] 0 0
Tremelo
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
Country [40] 0 0
Canada
State/province [40] 0 0
British Columbia
Country [41] 0 0
Canada
State/province [41] 0 0
Nova Scotia
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
Estonia
State/province [44] 0 0
Paide
Country [45] 0 0
Estonia
State/province [45] 0 0
Tallinn
Country [46] 0 0
Estonia
State/province [46] 0 0
Tartu
Country [47] 0 0
Finland
State/province [47] 0 0
Espoo
Country [48] 0 0
Finland
State/province [48] 0 0
Helsinki
Country [49] 0 0
Finland
State/province [49] 0 0
Jarvenpaa
Country [50] 0 0
Finland
State/province [50] 0 0
Kokkola
Country [51] 0 0
Finland
State/province [51] 0 0
Oulu
Country [52] 0 0
Finland
State/province [52] 0 0
Pori
Country [53] 0 0
Finland
State/province [53] 0 0
Seinajoki
Country [54] 0 0
Finland
State/province [54] 0 0
Tampere
Country [55] 0 0
Finland
State/province [55] 0 0
Turku
Country [56] 0 0
Germany
State/province [56] 0 0
Baden-Wuerttemberg
Country [57] 0 0
Germany
State/province [57] 0 0
Bayern
Country [58] 0 0
Germany
State/province [58] 0 0
Hessen
Country [59] 0 0
Germany
State/province [59] 0 0
Niedersachsen
Country [60] 0 0
Germany
State/province [60] 0 0
Nordrhein-Westfalen
Country [61] 0 0
Germany
State/province [61] 0 0
Rheinland-Pfalz
Country [62] 0 0
Germany
State/province [62] 0 0
Sachsen
Country [63] 0 0
Germany
State/province [63] 0 0
Schleswig-Holstein
Country [64] 0 0
Germany
State/province [64] 0 0
Berlin
Country [65] 0 0
Germany
State/province [65] 0 0
Hamburg
Country [66] 0 0
Italy
State/province [66] 0 0
Calabria
Country [67] 0 0
Italy
State/province [67] 0 0
Campania
Country [68] 0 0
Italy
State/province [68] 0 0
Emilia-Romagna
Country [69] 0 0
Italy
State/province [69] 0 0
Lazio
Country [70] 0 0
Italy
State/province [70] 0 0
Liguria
Country [71] 0 0
Italy
State/province [71] 0 0
Lombardia
Country [72] 0 0
Italy
State/province [72] 0 0
Piemonte
Country [73] 0 0
Italy
State/province [73] 0 0
Puglia
Country [74] 0 0
Italy
State/province [74] 0 0
Sicilia
Country [75] 0 0
Italy
State/province [75] 0 0
Toscana
Country [76] 0 0
Italy
State/province [76] 0 0
Veneto
Country [77] 0 0
Italy
State/province [77] 0 0
Chieri (TO)
Country [78] 0 0
Japan
State/province [78] 0 0
Chiba
Country [79] 0 0
Japan
State/province [79] 0 0
Hiroshima
Country [80] 0 0
Japan
State/province [80] 0 0
Ibaraki
Country [81] 0 0
Japan
State/province [81] 0 0
Kumamoto
Country [82] 0 0
Japan
State/province [82] 0 0
Okinawa
Country [83] 0 0
Japan
State/province [83] 0 0
Osaka
Country [84] 0 0
Japan
State/province [84] 0 0
Saitama
Country [85] 0 0
Japan
State/province [85] 0 0
Shizuoka
Country [86] 0 0
Japan
State/province [86] 0 0
Tokyo
Country [87] 0 0
Japan
State/province [87] 0 0
Yamagata
Country [88] 0 0
Japan
State/province [88] 0 0
Yamaguchi
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Daegu
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Gangwon-do
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Gyeonggi-do
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Gyeonggi
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Incheon
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Jeonju-si, Jeollabuk-do
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Seoul
Country [96] 0 0
Mexico
State/province [96] 0 0
Ciudad De Mexico
Country [97] 0 0
Mexico
State/province [97] 0 0
Guanajuato
Country [98] 0 0
Mexico
State/province [98] 0 0
Nuevo León
Country [99] 0 0
Mexico
State/province [99] 0 0
Querétaro
Country [100] 0 0
Mexico
State/province [100] 0 0
Yucatán
Country [101] 0 0
Mexico
State/province [101] 0 0
Chihuahua
Country [102] 0 0
Mexico
State/province [102] 0 0
Mexico City
Country [103] 0 0
Mexico
State/province [103] 0 0
Oaxaca
Country [104] 0 0
Mexico
State/province [104] 0 0
San Luis Potosí
Country [105] 0 0
New Zealand
State/province [105] 0 0
Auckland
Country [106] 0 0
New Zealand
State/province [106] 0 0
Havelock North
Country [107] 0 0
New Zealand
State/province [107] 0 0
Paraparaumu
Country [108] 0 0
New Zealand
State/province [108] 0 0
Tauranga
Country [109] 0 0
New Zealand
State/province [109] 0 0
Wellington
Country [110] 0 0
Poland
State/province [110] 0 0
Czestochowa
Country [111] 0 0
Poland
State/province [111] 0 0
Elblg
Country [112] 0 0
Poland
State/province [112] 0 0
Gdansk
Country [113] 0 0
Poland
State/province [113] 0 0
Gdynia
Country [114] 0 0
Poland
State/province [114] 0 0
Katowice
Country [115] 0 0
Poland
State/province [115] 0 0
Krakow
Country [116] 0 0
Poland
State/province [116] 0 0
Lodz
Country [117] 0 0
Poland
State/province [117] 0 0
Piaseczno
Country [118] 0 0
Poland
State/province [118] 0 0
Poznan
Country [119] 0 0
Poland
State/province [119] 0 0
Sochaczew
Country [120] 0 0
Poland
State/province [120] 0 0
Warszawa
Country [121] 0 0
Poland
State/province [121] 0 0
Wroclaw
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Barnaul
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Ekaterinburg
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Gatchina
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Kemerovo
Country [126] 0 0
Russian Federation
State/province [126] 0 0
Moscow
Country [127] 0 0
Russian Federation
State/province [127] 0 0
Saint Petersburg
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Saint-Petersburg
Country [129] 0 0
Russian Federation
State/province [129] 0 0
St.Petersburg
Country [130] 0 0
South Africa
State/province [130] 0 0
Gauteng
Country [131] 0 0
South Africa
State/province [131] 0 0
Mpumalanga
Country [132] 0 0
South Africa
State/province [132] 0 0
Bloemfontein
Country [133] 0 0
South Africa
State/province [133] 0 0
Mowbray
Country [134] 0 0
Spain
State/province [134] 0 0
Alcorcón (Madrid)
Country [135] 0 0
Spain
State/province [135] 0 0
Barcelona
Country [136] 0 0
Spain
State/province [136] 0 0
Centelles (Barcelona)
Country [137] 0 0
Spain
State/province [137] 0 0
Hospitalet de Llobregat
Country [138] 0 0
Spain
State/province [138] 0 0
La Roca del Vallès
Country [139] 0 0
Spain
State/province [139] 0 0
Madrid
Country [140] 0 0
Spain
State/province [140] 0 0
Majadahonda (Madrid)
Country [141] 0 0
Spain
State/province [141] 0 0
Santiago de Compostela
Country [142] 0 0
Spain
State/province [142] 0 0
Valencia
Country [143] 0 0
Spain
State/province [143] 0 0
Vic
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Cambridgeshire
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Kent
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Lanarkshire
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Lancashire
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Norfolk
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Northamptonshire
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Warwickshire
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Wiltshire
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Bebington
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Belfast
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Birmingham
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Eynsham
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Gwaelod-y-Garth, Cardiff
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Hexham
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Liverpool
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Manchester
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Oxford
Country [161] 0 0
United Kingdom
State/province [161] 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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?
IPD for this study will be made available via the Clinical Study Data Request site.

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)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04886596