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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05298254




Registration number
NCT05298254
Ethics application status
Date submitted
4/03/2022
Date registered
28/03/2022

Titles & IDs
Public title
A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
Scientific title
A Phase I/II, Observer-blind, Randomised, Placebo-controlled, Multi-country Study to Evaluate Reactogenicity, Safety, Immune Response, and Efficacy of an HSV-targeted Immunotherapy in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
Secondary ID [1] 0 0
2021-003586-35
Secondary ID [2] 0 0
215336
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Simplex 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions
Infection 0 0 0 0
Sexually transmitted infections
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Non-adjuvanted HSV formulation 1
Treatment: Other - Non-adjuvanted HSV formulation 2
Treatment: Other - Non-adjuvanted HSV formulation 3
Treatment: Other - HSV formulation 1 with adjuvant 1
Treatment: Other - HSV formulation 2 with adjuvant 1
Treatment: Other - HSV formulation 3 with adjuvant 1
Treatment: Other - HSV formulation 1 with adjuvant 2
Treatment: Other - HSV formulation 2 with adjuvant 2
Treatment: Other - HSV formulation 3 with adjuvant 2
Treatment: Drugs - Placebo
Treatment: Other - HSVTI_F1
Treatment: Other - HSVTI_F2

Experimental: Non-adjuvanted HSV formulation 1 - Part I Group - Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 1 vaccine, one at Day 1 and one at Day 29.

Experimental: Non-adjuvanted HSV formulation 2 - Part I Group - Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 2 vaccine, one at Day 1 and one at Day 29.

Experimental: Non-adjuvanted HSV formulation 3 - Part I Group - Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 3 vaccine, one at Day 1 and one at Day 29.

Experimental: HSV formulation 1 with adjuvant 1 - Part I Group - Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.

Experimental: HSV formulation 2 with adjuvant 1 - Part I Group - Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.

Experimental: HSV formulation 3 with adjuvant 1 - Part I Group - Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.

Experimental: HSV formulation 1 with adjuvant 2 - Part I Group - Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.

Experimental: HSV formulation 2 with adjuvant 2 - Part I Group - Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.

Experimental: HSV formulation 3 with adjuvant 2 - Part I Group - Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.

Placebo comparator: Placebo - Part I Group - Participants enrolled in Part I of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.

Experimental: HSVTI formulation (F) 1 - Part II Group - Participants enrolled in Part II of the study who receive 2 doses of the formulation of the HSVTI_F1 selected from Part I of the study, one at Day 1 and one at Day 29.

Experimental: HSVTI_F2 - Part II Group - Participants enrolled in Part II of the study who receive 2 doses of the HSVTI_F2 selected from Part I of the study, one at Day 1 and one at Day 29.

Placebo comparator: Placebo - Part II Group - Participants enrolled in Part II of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.


Treatment: Other: Non-adjuvanted HSV formulation 1
Two doses of the non-adjuvanted HSV formulation 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

Treatment: Other: Non-adjuvanted HSV formulation 2
Two doses of the non-adjuvanted HSV formulation 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

Treatment: Other: Non-adjuvanted HSV formulation 3
Two doses of the non-adjuvanted HSV formulation 3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

Treatment: Other: HSV formulation 1 with adjuvant 1
Two doses of the HSV formulation 1 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

Treatment: Other: HSV formulation 2 with adjuvant 1
Two doses of the HSV formulation 2 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

Treatment: Other: HSV formulation 3 with adjuvant 1
Two doses of the HSV formulation 3 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

Treatment: Other: HSV formulation 1 with adjuvant 2
Two doses of the HSV formulation 1 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

Treatment: Other: HSV formulation 2 with adjuvant 2
Two doses of the HSV formulation 2 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

Treatment: Other: HSV formulation 3 with adjuvant 2
Two doses of the HSV formulation 3 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

Treatment: Drugs: Placebo
Two doses of Placebo administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I and Part II of the study.

Treatment: Other: HSVTI_F1
Two doses of the formulation of the HSVTI_F1 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study.

Treatment: Other: HSVTI_F2
Two doses of the formulation of the HSVTI_F2 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants reporting each solicited administration site event
Timepoint [1] 0 0
Within 7 days after the first study intervention dose (administered at Day 1)
Primary outcome [2] 0 0
Percentage of participants reporting each solicited administration site event
Timepoint [2] 0 0
Within 7 days after the second study intervention dose (administered at Day 29)
Primary outcome [3] 0 0
Percentage of participants reporting each solicited systemic event
Timepoint [3] 0 0
Within 7 days after the first study intervention dose (administered at Day 1)
Primary outcome [4] 0 0
Percentage of participants reporting each solicited systemic event
Timepoint [4] 0 0
Within 7 days after the second study intervention dose (administered at Day 29)
Primary outcome [5] 0 0
Percentage of participants reporting unsolicited adverse events (AEs)
Timepoint [5] 0 0
Within 28 days after the first study intervention dose (administered at Day 1)
Primary outcome [6] 0 0
Percentage of participants reporting unsolicited adverse events (AEs)
Timepoint [6] 0 0
Within 28 days after the second study intervention dose (administered at Day 29)
Primary outcome [7] 0 0
Percentage of participants reporting medically attended events (MAEs)
Timepoint [7] 0 0
From Dose 1 (Day 1) up 12 months after last study intervention administration (Day 394)
Primary outcome [8] 0 0
Percentage of participants reporting any serious adverse events (SAEs)
Timepoint [8] 0 0
From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
Primary outcome [9] 0 0
Percentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events)
Timepoint [9] 0 0
From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
Primary outcome [10] 0 0
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the study
Timepoint [10] 0 0
At pre-study intervention administration (Day 1)
Primary outcome [11] 0 0
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part I of the study
Timepoint [11] 0 0
At Day 8
Primary outcome [12] 0 0
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in Part I of the study
Timepoint [12] 0 0
At Day 29
Primary outcome [13] 0 0
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part I of the study
Timepoint [13] 0 0
At Day 36
Primary outcome [14] 0 0
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64 in Part I of the study
Timepoint [14] 0 0
At Day 64
Primary outcome [15] 0 0
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part II of the study
Timepoint [15] 0 0
At pre-study intervention administration (Day 1)
Primary outcome [16] 0 0
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part II of the study
Timepoint [16] 0 0
At Day 8
Primary outcome [17] 0 0
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in part II of the study
Timepoint [17] 0 0
At Day 29
Primary outcome [18] 0 0
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part II of the study
Timepoint [18] 0 0
At Day 36
Primary outcome [19] 0 0
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57 in Part II of the study
Timepoint [19] 0 0
At Day 57
Primary outcome [20] 0 0
Time-to-first confirmed HSV-2 RGH episode in Part II of the study
Timepoint [20] 0 0
14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Secondary outcome [1] 0 0
Number of confirmed HSV-2 RGH episodes in Part II of the study
Timepoint [1] 0 0
14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Secondary outcome [2] 0 0
Percentage of participants free from confirmed HSV-2 RGH episode in Part II of the study
Timepoint [2] 0 0
At 6 months after the last study intervention administration (Day 29)
Secondary outcome [3] 0 0
Herpes Symptoms Checklist (HSC) total score during each confirmed HSV-2 RGH episode in Part II of the study
Timepoint [3] 0 0
14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Secondary outcome [4] 0 0
Number of days with RGH-associated symptoms during each confirmed HSV-2 RGH episode in Part II of the study
Timepoint [4] 0 0
14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Secondary outcome [5] 0 0
Number of days with confirmed HSV-2 genital herpes lesions in Part II of the study
Timepoint [5] 0 0
14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Secondary outcome [6] 0 0
HSV-2 shedding rate reduction from baseline to 6 weeks post-Dose 2 (Day 71) in Part II of the study
Timepoint [6] 0 0
At 6 weeks post-Dose 2 (Day 71) compared to baseline (Day -28 to Day -1)
Secondary outcome [7] 0 0
Number of HSV-2 DNA shedding episodes in Part II of the study
Timepoint [7] 0 0
Day -28 to Day -1
Secondary outcome [8] 0 0
Number of HSV-2 DNA shedding episodes in Part II of the study
Timepoint [8] 0 0
Day 43 to Day 70
Secondary outcome [9] 0 0
Number of HSV-2 DNA shedding episodes in Part II of the study
Timepoint [9] 0 0
Day 181 to Day 208
Secondary outcome [10] 0 0
Duration of HSV-2 DNA shedding episodes in Part II of the study
Timepoint [10] 0 0
Day -28 to Day -1
Secondary outcome [11] 0 0
Duration of HSV-2 DNA shedding episodes in Part II of the study
Timepoint [11] 0 0
Day 43 to Day 70
Secondary outcome [12] 0 0
Duration of HSV-2 DNA shedding episodes in Part II of the study
Timepoint [12] 0 0
Day 181 to Day 208
Secondary outcome [13] 0 0
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part I of the study
Timepoint [13] 0 0
At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Secondary outcome [14] 0 0
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part II of the study
Timepoint [14] 0 0
At pre-study intervention administration (Day 1), Day 29 and Day 57
Secondary outcome [15] 0 0
Percentage of seropositive participants for anti-HSVTI antibodies in Part I of the study
Timepoint [15] 0 0
At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Secondary outcome [16] 0 0
Percentage of seropositive participants for anti-HSVTI antibodies in Part II of the study
Timepoint [16] 0 0
At pre-study intervention administration (Day 1), Day 29 and Day 57
Secondary outcome [17] 0 0
Geometric mean of HSVTI-specific Cluster of Differentiation (CD)4+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the study
Timepoint [17] 0 0
At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Secondary outcome [18] 0 0
Geometric mean of HSVTI-specific CD4+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the study
Timepoint [18] 0 0
At pre-study intervention administration (Day 1), Day 29 and Day 57
Secondary outcome [19] 0 0
Geometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the study
Timepoint [19] 0 0
At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Secondary outcome [20] 0 0
Geometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the study
Timepoint [20] 0 0
At pre-study intervention administration (Day 1), Day 29 and Day 57

Eligibility
Key inclusion criteria
* • Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol.
* Written informed consent obtained from the participant prior to performance of any study-specific procedure.
* Women of non-childbearing potential can be enrolled in the study.
* Women of childbearing potential can be enrolled in the study, if the participant:

* Has practiced highly effective contraception for one month prior to study intervention administration, and,
* Has a negative pregnancy test result at the Screening visit and on the day of each study intervention administration, and,
* For PART I: Has agreed to continue highly effective contraception until the end of the study.
* For PART II: Has agreed to continue highly effective contraception until 3 months after last study intervention administration.
* Seronegative for human immunodeficiency virus (HIV), as determined by laboratory screening tests. Participants documented to be seropositive to HIV will not be eligible for study participation.
* Only for PART I: Healthy participants as established by medical history and physical examination, at the discretion of the investigator, before entering into the study.
* Only for PART I: Man or woman aged 18 to 40 years, included, at the time of the first study intervention administration.
* Only for PART I: Seronegative for HSV-2 as determined by Western blot performed at the Screening visit.
* Only for PART II: Participants with recurrent genital herpes and with no significant health problems as established by medical history and physical examination, at the discretion of the investigator, before entering the study.

* Diagnosis of genital herpes for at least one year before the Screening visit.
* History of self-reported or documented recurrent lesional genital herpes frequency of at least 3 and no more than 9 reported clinical recurrences in the 12 months preceding the screening visit, or, if still on suppressive therapy within 3 months before the Screening visit, prior to initiation of suppressive therapy.
* Only for PART II: Man or woman aged 18 to 60 years, included, at the time of the first study intervention administration.
* Only for PART II: Seropositive for HSV-2 as determined by serological testingperformed at the Screening visit, or having documented laboratory-confirmed HSV 2 genital herpes (i.e., HSV-2 DNA positive by a molecular technique such as polymerase chain reaction [PCR], or HSV-2 seropositive by a type-specific serology assay such as Western Blot or other immunoassay).Only for PART II (shedding sub-cohort): Participants agreeing to collect 2 swabs per day from anogenital area for the full duration of the 5 swabbing periods planned in the study.
* Only for PART II (shedding sub-cohort) after baseline completion: Participants having collected at least 45 out of 56 anogenital swabs during the baseline period.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical Conditions

* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study or that would interfere with the efficacy and immunogenicity assessments planned in this study.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Hypersensitivity to latex.
* Recurrent history or uncontrolled neurological disorders or seizures.
* Haematological and/or biochemical parameters outside the normal laboratory ranges at the Screening visit, unless the laboratory abnormalities are considered not clinically significant by the investigator.
* Body mass index =<18 kg/m^2 or >=35 kg/m^2.
* Past or current Guillain-Barré syndrome.
* History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications.

Prior/Concomitant Therapy

* Use of any investigational or non-registered product other than the study intervention during the period beginning as of the Screening visit, or planned use during the study period.
* Planned administration/administration of a vaccine not foreseen by the Protocol in the period starting 15 days before each dose and ending 15 days after each dose of study intervention administration.
* Administration or planned administration of long-acting immune-modifying drugs at any time during the study period.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose. For corticosteroids, this will mean prednisone equivalent >= 20 mg/day, or equivalent. Inhaled, intra articular and topical steroids are allowed.
* Prior receipt of another vaccine containing HSV antigens.
* Only for PART II: Planned use of suppressive anti-HSV therapy from the Screening visit until the end of the study.
* Only for PART II: Planned use of tenofovir therapy, or other medication known to affect HSV shedding or genital lesions from the Screening visit until the end of the study. Only for PART II: Planned use of topical antiviral medication in the anogenital region from the Screening visit until the end of the study.
* Only for PART II: Planned use of any episodic antiviral medications during the swabbing periods (including the baseline period) (only for the shedding sub-cohort).

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.

Other Exclusions

* Pregnant or lactating women.
* Woman planning to become pregnant or planning to discontinue contraceptive precautions in the period starting from the Screening visit up to 3 months post-last dose of study intervention.

Study design
Purpose of the study
Treatment
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 1
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
7/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/07/2025
Actual
Sample size
Target
Accrual to date
Final
505
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Sydney
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
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Belgium
State/province [7] 0 0
Antwerpen
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussels
Country [9] 0 0
Belgium
State/province [9] 0 0
Edegem
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Estonia
State/province [12] 0 0
Tartu
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Bochum
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Germany
State/province [17] 0 0
Koeln
Country [18] 0 0
Spain
State/province [18] 0 0
Badalona
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Marbella
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Brighton
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Liverpool
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Southampton

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
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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?
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gskstudyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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, a 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?
IPD available at link: https://www.gskstudyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf


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/NCT05298254