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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04886154




Registration number
NCT04886154
Ethics application status
Date submitted
10/05/2021
Date registered
13/05/2021

Titles & IDs
Public title
A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults
Scientific title
A Phase I/II, Randomised, Controlled Study to Assess the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Adults (Phase I) and to Healthy Adolescents and Adults (Phase II)
Secondary ID [1] 0 0
2020-004741-37
Secondary ID [2] 0 0
212458
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Meningococcal 0 0
Condition category
Condition code
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
Other interventions - MenABCWY-2Gen low dose vaccine
Other interventions - MenABCWY-2Gen high dose vaccine
Other interventions - Placebo
Other interventions - MenB vaccine
Treatment: Other - MenACWY vaccine

Experimental: ABCWY low dose Group - Participants receive MenABCWY-2Gen low dose vaccine and are followed up until Day 211 in study Phase I.

Placebo comparator: Placebo low dose Group - Participants receive NaCl as a control for ABCWY low dose group and are followed up until Day 211 in study Phase I.

Experimental: ABCWY high dose Group - Participants receive MenABCWY-2Gen high dose vaccine and are followed up until Day 211 in study Phase I.

Placebo comparator: Placebo high dose Group - Participants receive NaCl as a control for ABCWY high dose group and are followed up until Day 211 in study Phase I.

Experimental: ABCWY low dose_06 Group - Participants receive MenABCWY-2Gen low dose vaccine in a 0, 6 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).

Experimental: ABCWY low dose_02 Group - Participants receive MenABCWY-2Gen low dose vaccine in a 0, 2 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).

Experimental: ABCWY high dose_06 Group - Participants receive MenABCWY-2Gen high dose vaccine in a 0, 6 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).

Experimental: ABCWY high dose_02 Group - Participants receive MenABCWY-2Gen high dose vaccine in a 0,2 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).

Active comparator: Control Group - Participants randomized to Control Group receive 2 doses of Bexsero (MenB) vaccine and 1 dose of Menveo (MenACWY), 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).

Experimental: ABCWY low dose_01 Group - Participants receive MenABCWY-2Gen low dose vaccine in a 0,1 month schedule and are followed up until Day 211 in study Phase II (Sourcing).

Experimental: ABCWY high dose_01 Group - Participants receive MenABCWY-2Gen high dose vaccine in a 0,1 month schedule and are followed up until Day 211 in study Phase II (Sourcing).

Experimental: ABCWY low doseS_02 Group - Participants receive MenABCWY-2Gen low dose vaccine in a 0, 2 month schedule and are followed up until Day 241 in study Phase II (Sourcing).

Experimental: ABCWY high doseS_02 Group - Participants receive MenABCWY-2Gen high dose vaccine in a 0, 2 month schedule and are followed up until Day 241 in study Phase II (Sourcing).

Experimental: ABCWY low doseS_06 Group - Participants receive MenABCWY-2Gen low dose vaccine in a 0, 6 month schedule and are followed up until Day 361 in study Phase II (Sourcing).

Experimental: ABCWY high doseS_06 Group - Participants receive MenABCWY-2Gen high dose vaccine in a 0, 6 month schedule and are followed up until Day 361 in study Phase II (Sourcing).


Other interventions: MenABCWY-2Gen low dose vaccine
MenABCWY-2Gen low dose vaccine is administered intramuscularly in the deltoid region of the non-dominant arm as 2 doses to participants in the ABCWY low dose Group in study Phase I, ABCWY low dose_06 Group and ABCWY low dose_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY low dose_01 Group, ABCWY low doseS_02 Group and ABCWY low doseS_06 Group in study Phase II (Sourcing).

Other interventions: MenABCWY-2Gen high dose vaccine
MenABCWY-2Gen high dose vaccine is administered intramuscularly in the deltoid region of the non-dominant arm as 2 doses to participants in the ABCWY high dose Group in study Phase I, ABCWY high dose_06 Group and ABCWY high dose_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY high dose_01 Group, ABCWY high doseS_02 Group and ABCWY high doseS_06 Group in study Phase II (Sourcing).

Other interventions: Placebo
Placebo is administered intramuscularly in the deltoid region of the non-dominant arm as 2 doses to participants in the Placebo low dose Group, Placebo high dose Group in study Phase I and as 1 dose to participants in the ABCWY low dose_06 Group, ABCWY low dose_02 Group, ABCWY high dose_06 Group, ABCWY high dose_02 Group in study Phase II (Formulation and Schedule-finding).

Other interventions: MenB vaccine
MenB vaccine is administered intramuscularly in the deltoid region of the non-dominant arm, whenever it's possible, as 2 doses in a 0,6-months schedule to participants in the Control Group in study Phase II (Formulation and Schedule-finding).

Treatment: Other: MenACWY vaccine
MenACWY vaccine is administered intramuscularly in the deltoid region of the dominant arm as 1 dose to participants in the Control Group in study Phase II (Formulation and Schedule-finding).
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentages of participants with solicited administration site events in study Phase I (Safety Lead-in)
Timepoint [1] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 1
Primary outcome [2] 0 0
Percentages of participants with solicited administration site events in study Phase I (Safety Lead-in)
Timepoint [2] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 31
Primary outcome [3] 0 0
Percentages of participants with solicited systemic events in study Phase I (Safety Lead-in)
Timepoint [3] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 1
Primary outcome [4] 0 0
Percentages of participants with solicited systemic events in study Phase I (Safety Lead-in)
Timepoint [4] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 31
Primary outcome [5] 0 0
Percentages of participants with any unsolicited adverse events (AEs), including all serious adverse events (SAEs), AEs leading to withdrawal and AEs of special interest (AESIs) in study Phase I (Safety Lead-in)
Timepoint [5] 0 0
During the 30 days (including the day of vaccination) following vaccination at Day 1
Primary outcome [6] 0 0
Percentages of participants with any unsolicited adverse events (AEs), including all serious adverse events (SAEs), AEs leading to withdrawal and AEs of special interest (AESIs) in study Phase I (Safety Lead-in)
Timepoint [6] 0 0
During the 30 days (including the day of vaccination) following vaccination at Day 31
Primary outcome [7] 0 0
Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase I (Safety Lead-in)
Timepoint [7] 0 0
Throughout the study period (Day 1 through Day 211)
Primary outcome [8] 0 0
Percentages of participants with haematological and biochemical laboratory abnormalities, and changes from the baseline values, in study Phase I (Safety Lead-in)
Timepoint [8] 0 0
At Day 8 after the first vaccination
Primary outcome [9] 0 0
Percentages of samples with bactericidal serum activity against a panel of 110 randomly selected endemic US N. meningitidis serogroup B invasive disease strains in study Phase II (Formulation and Schedule-finding)
Timepoint [9] 0 0
At Day 211 (1 month after the last vaccination)
Primary outcome [10] 0 0
Percentages of participants with a 4-fold rise in hSBA titers against serogroups A, C, W and Y in study Phase II (Formulation and Schedule-finding)
Timepoint [10] 0 0
At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY groups and at Day 31 the Control group)
Primary outcome [11] 0 0
Percentages of participants with solicited administration site events in study Phase II (Formulation and Schedule-finding)
Timepoint [11] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 1
Primary outcome [12] 0 0
Percentages of participants with solicited administration site events in study Phase II (Formulation and Schedule-finding)
Timepoint [12] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 121
Primary outcome [13] 0 0
Percentages of participants with solicited administration site events in study Phase II (Formulation and Schedule-finding)
Timepoint [13] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 181
Primary outcome [14] 0 0
Percentages of participants with solicited systemic events in study Phase II (Formulation and Schedule-finding)
Timepoint [14] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 1
Primary outcome [15] 0 0
Percentages of participants with solicited systemic events in study Phase II (Formulation and Schedule-finding)
Timepoint [15] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 121
Primary outcome [16] 0 0
Percentages of participants with solicited systemic events in study Phase II (Formulation and Schedule-finding)
Timepoint [16] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 181
Primary outcome [17] 0 0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Formulation and Schedule-finding)
Timepoint [17] 0 0
During the 30 days (including the day of vaccination) following vaccination at Day 1
Primary outcome [18] 0 0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Formulation and Schedule-finding)
Timepoint [18] 0 0
During the 30 days (including the day of vaccination) following vaccination at Day 121
Primary outcome [19] 0 0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Formulation and Schedule-finding)
Timepoint [19] 0 0
During the 30 days (including the day of vaccination) following vaccination at Day 181
Primary outcome [20] 0 0
Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Formulation and Schedule-Finding)
Timepoint [20] 0 0
Throughout the study period (Day 1 through Day 541)
Primary outcome [21] 0 0
Percentages of participants with solicited administration site events in study Phase II (Sourcing)
Timepoint [21] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 1
Primary outcome [22] 0 0
Percentages of participants with solicited administration site events in study Phase II (Sourcing)
Timepoint [22] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 31
Primary outcome [23] 0 0
Percentages of participants with solicited administration site events in study Phase II (Sourcing)
Timepoint [23] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 61
Primary outcome [24] 0 0
Percentages of participants with solicited administration site events in study Phase II (Sourcing)
Timepoint [24] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 181
Primary outcome [25] 0 0
Percentages of participants with solicited systemic events in study Phase II (Sourcing)
Timepoint [25] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 1
Primary outcome [26] 0 0
Percentages of participants with solicited systemic events in study Phase II (Sourcing)
Timepoint [26] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 31
Primary outcome [27] 0 0
Percentages of participants with solicited systemic events in study Phase II (Sourcing)
Timepoint [27] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 61
Primary outcome [28] 0 0
Percentages of participants with solicited systemic events in study Phase II (Sourcing)
Timepoint [28] 0 0
During the 7 days (including the day of vaccination) following vaccination at Day 181
Primary outcome [29] 0 0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing)
Timepoint [29] 0 0
During the 30 days (including the day of vaccination) following vaccination at Day 1
Primary outcome [30] 0 0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing)
Timepoint [30] 0 0
During the 30 days (including the day of vaccination) following vaccination at Day 31
Primary outcome [31] 0 0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing)
Timepoint [31] 0 0
During the 30 days (including the day of vaccination) following vaccination at Day 61
Primary outcome [32] 0 0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing)
Timepoint [32] 0 0
During the 30 days (including the day of vaccination) following vaccination at Day 181
Primary outcome [33] 0 0
Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Sourcing)
Timepoint [33] 0 0
Throughout the study period (Day 1 through Day 211)
Primary outcome [34] 0 0
Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Sourcing)
Timepoint [34] 0 0
Throughout the study period (Day 1 through Day 241)
Primary outcome [35] 0 0
Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Sourcing)
Timepoint [35] 0 0
Throughout the study period (Day 1 through Day 361)
Secondary outcome [1] 0 0
Percentages of serogroup B invasive disease strains killed in each participant sample in study Phase II (Formulation and Schedule-finding)
Timepoint [1] 0 0
At Day 211 (1 month after the last vaccination)
Secondary outcome [2] 0 0
Percentages of participants with hSBA titers =LLOQ for each and all serogroup B indicator strains in study Phase II (Formulation and Schedule-finding)
Timepoint [2] 0 0
At Day 1 in ABCWY (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2-months) and Day 211 in all study groups
Secondary outcome [3] 0 0
Percentages of participants with 4-fold rise in hSBA titers against serogroup B indicator strains in study Phase II (Formulation and Schedule-finding)
Timepoint [3] 0 0
At Day 211 (1 month after the last vaccination)
Secondary outcome [4] 0 0
hSBA Geometric mean titers (GMTs) against serogroup B indicator strains in study Phase II (Formulation and Schedule-finding)
Timepoint [4] 0 0
At Day 1 in ABCWY groups (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2-months) and Day 211 in all study groups
Secondary outcome [5] 0 0
hSBA Geometric mean ratios (GMRs) against serogroup B indicator strains in study Phase II (Formulation and Schedule-finding)
Timepoint [5] 0 0
At Day 211 in all study groups versus Day 1 in ABCWY (0,6-months) and Control groups and Day 31 in ABCWY groups (0,2-months)
Secondary outcome [6] 0 0
Percentages of participants with hSBA titers = LLOQ for serogroups A, C, W and Y in study Phase II (Formulation and Schedule-finding)
Timepoint [6] 0 0
At Day 1 in ABCWY (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2- and 0,6-months), Day 211 (1 month after the last vaccination) in all ABCWY groups and Day 31 (1 month after the MenACWY vaccination) in Control group
Secondary outcome [7] 0 0
Percentages of participants with a 4-fold rise in hSBA titers against serogroups A, C, W and Y in study Phase II (Formulation and Schedule-finding)
Timepoint [7] 0 0
At Day 31 (1 month after the first MenABCWY-2Gen vaccination)
Secondary outcome [8] 0 0
hSBA GMTs against serogroups A, C, W and Y
Timepoint [8] 0 0
At Day 1 in ABCWY groups (0,6-months) and Control group, Day 31 in ABCWY groups (0,2-months and 0,6-moths), Day 211 in all ABCWY groups and Day 31 in the Control group
Secondary outcome [9] 0 0
hSBA GMRs against serogroups A, C, W and Y
Timepoint [9] 0 0
At Day 31 versus Day 1 in ABCWY (0,6-months) and Control groups, Day 211 versus Day 1 in ABCWY (0,6-months) groups and Day 211 versus Day 31 in ABCWY (0,2-months) groups
Secondary outcome [10] 0 0
Immunoglobulin G (IgG) antibodies against serogroups A, C, W and Y
Timepoint [10] 0 0
At Day 1 in ABCWY groups (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2-months) and Day 31 in the ABCWY groups (0,6-months) and in Control group, and Day 211 for all ABCWY groups

Eligibility
Key inclusion criteria
All inclusion criteria are applicable for both study phases, except where specified otherwise.

* Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the eDiaries, return for follow-up visits).
* Written or witnessed/thumb printed informed consent obtained from the participant or /parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
* Written informed assent obtained from the participant (if applicable) prior to performing any study specific procedure.
* Phase I only: A male or female between, and including, 18 and 40 years of age (i.e. 40 years + 364 days) at the time of the first study intervention administration.
* Phase II (Formulation and Schedule-finding) only: A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364 days) at the time of the first study intervention administration.
* Phase II (Sourcing) only: A male or female between, and including, 18 and 50 years of age (i.e. 50 years + 364 days) at the time of the first study intervention administration.
* Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine can participate in the study, if they have received it at least 4 years prior to informed consent and assent as applicable (with the exception of meningococcal C vaccination, if the last dose of MenC was received at =24 months of age).
* Healthy participants as established by medical history and clinical examination before entering into the study.
* Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
* Female participants of childbearing potential may be enrolled in the study, if the participant:

* has practiced adequate contraception for 1 month prior to study intervention administration, and
* has a negative pregnancy test on the day of study intervention administration, and
* has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration.
Minimum age
10 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical conditions

* Current or previous, confirmed or suspected disease caused by N. meningitidis.
* Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment.
* Progressive, unstable or uncontrolled clinical conditions.
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* Are obese at enrolment (e.g. for participants from 20 years of age a body mass index (BMI) = 30 kg/m2, for participants up to 19 years of age a BMI = 95th percentile for age and gender or as applicable per country recommendations).
* Any neuroinflammatory (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
* Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study.
* Abnormal function or modification of the immune system resulting from:

* Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
* Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 3 months prior to study vaccination until the last blood sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding). This will mean prednisone equivalent =20 mg/day for adult participants/ =0.5 mg/kg/day with maximum of 20 mg/day for paediatric participants. Inhaled and topical steroids are allowed.
* Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
* Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
* 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(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period.
* Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration until the last blood sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding).
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s) until the last blood sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding). For corticosteroids, this will mean prednisone equivalent =20 mg/day for adult participants/ =0.5 mg/kg/day with maximum of 20 mg/day for paediatric participants. 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 intervention (drug/invasive medical device).

Other exclusions

* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator.
* Any study personnel or immediate dependents, family, or household member.
* Phase II (Formulation and Schedule-finding): Child in care.

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 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/11/2024
Sample size
Target
Accrual to date
Final
1429
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Fortitude Valley
Recruitment hospital [3] 0 0
GSK Investigational Site - Taringa
Recruitment hospital [4] 0 0
GSK Investigational Site - Tarragindi
Recruitment hospital [5] 0 0
GSK Investigational Site - Murdoch
Recruitment hospital [6] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4006 - Fortitude Valley
Recruitment postcode(s) [3] 0 0
4068 - Taringa
Recruitment postcode(s) [4] 0 0
4121 - Tarragindi
Recruitment postcode(s) [5] 0 0
6163 - Murdoch
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
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
Belgium
State/province [10] 0 0
Brussels
Country [11] 0 0
Belgium
State/province [11] 0 0
Edegem
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Linkebeek
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio de Janeiro
Country [15] 0 0
Brazil
State/province [15] 0 0
Salvador
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Jose Do Rio Preto
Country [17] 0 0
Brazil
State/province [17] 0 0
SAo Paulo
Country [18] 0 0
Finland
State/province [18] 0 0
Helsinki
Country [19] 0 0
Finland
State/province [19] 0 0
Turku
Country [20] 0 0
Poland
State/province [20] 0 0
Bydgoszcz
Country [21] 0 0
Poland
State/province [21] 0 0
Elblag
Country [22] 0 0
Poland
State/province [22] 0 0
Katowice
Country [23] 0 0
Poland
State/province [23] 0 0
Krakow
Country [24] 0 0
Poland
State/province [24] 0 0
Lubon
Country [25] 0 0
Poland
State/province [25] 0 0
Siemianowice Slaskie
Country [26] 0 0
Poland
State/province [26] 0 0
Tarnow
Country [27] 0 0
Poland
State/province [27] 0 0
Torun
Country [28] 0 0
Poland
State/province [28] 0 0
Trzebnica
Country [29] 0 0
Poland
State/province [29] 0 0
Warsaw
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Poland
State/province [31] 0 0
Wroclaw
Country [32] 0 0
Sweden
State/province [32] 0 0
Boras
Country [33] 0 0
Sweden
State/province [33] 0 0
Karlskrona
Country [34] 0 0
Sweden
State/province [34] 0 0
Orebro
Country [35] 0 0
Sweden
State/province [35] 0 0
Stockholm
Country [36] 0 0
Sweden
State/province [36] 0 0
Umea
Country [37] 0 0
Turkey
State/province [37] 0 0
Istanbul
Country [38] 0 0
Turkey
State/province [38] 0 0
Kocaeli

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
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for public queries
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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?

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/NCT04886154