Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02603432




Registration number
NCT02603432
Ethics application status
Date submitted
9/11/2015
Date registered
11/11/2015

Titles & IDs
Public title
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
Scientific title
A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY
Secondary ID [1] 0 0
2015-003262-86
Secondary ID [2] 0 0
B9991001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Avelumab
Other interventions - Best Supportive Care
Treatment: Other - Following the planned interim analysis for this study: Avelumab

Experimental: Arm A - Avelumab plus Best Supportive Care (BSC)

Other: Arm B - Best Supportive Care (BSC) alone

Following the planned interim analysis for this study, eligible patients in Arm B whose cancer has not worsened and are still in the "watch and wait" part of the study will be given the option to receive Avelumab plus BSC. Prior to this, Arm B patients received BSC alone. All patients who choose not to receive Avelumab will be discontinued.


Treatment: Other: Avelumab
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles

Other interventions: Best Supportive Care
BSC will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable.

Treatment: Other: Following the planned interim analysis for this study: Avelumab
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) as Assessed by Investigator
Timepoint [2] 0 0
From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
Secondary outcome [3] 0 0
Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [3] 0 0
From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)
Secondary outcome [4] 0 0
Percentage of Participants With Objective Response as Assessed by Investigator
Timepoint [4] 0 0
From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)
Secondary outcome [5] 0 0
Time to Tumor Response (TTR) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [5] 0 0
From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)
Secondary outcome [6] 0 0
Time to Tumor Response (TTR) as Assessed by Investigator
Timepoint [6] 0 0
From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)
Secondary outcome [7] 0 0
Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [7] 0 0
First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months)
Secondary outcome [8] 0 0
Duration of Response (DOR) as Assessed by Investigator
Timepoint [8] 0 0
First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months)
Secondary outcome [9] 0 0
Percentage of Participants With Disease Control (DC) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [9] 0 0
From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months)
Secondary outcome [10] 0 0
Percentage of Participants With Disease Control (DC) as Assessed by Investigator
Timepoint [10] 0 0
From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months)
Secondary outcome [11] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
Timepoint [11] 0 0
For "Avelumab + Best Supportive Care (BSC)'' group: Day1 up to 90 days after last dose of study drug; for BSC group: Day1 up to 90 days after EOT visit (for a maximum duration of up to approximately 70 months for both groups)
Secondary outcome [12] 0 0
Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3 (G3), Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
Timepoint [12] 0 0
For "Avelumab + Best Supportive Care (BSC)'' group: Day1 up to 90 days after last dose of study drug; for BSC group: Day1 up to 90 days after EOT visit (for a maximum duration of up to approximately 70 months for both groups)
Secondary outcome [13] 0 0
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit
Timepoint [13] 0 0
Baseline (Day [D] 1 of Cycle [C] 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7 , EOT visit (for a maximum duration of 41 months) (each cycle=28 days)
Secondary outcome [14] 0 0
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit
Timepoint [14] 0 0
Baseline (Day [D] 1 of Cycle [C] 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7 , EOT visit (for a maximum duration of 41 months) (each cycle=28 days)
Secondary outcome [15] 0 0
Maximum Plasma Concentration (Cmax) of Avelumab
Timepoint [15] 0 0
End of avelumab infusion on Day 1 of Cycle 1, 2, 3, 5, 7, 9, 11, 13 and Day 15 of Cycle 1, 2, 3 (each cycle=28 days)
Secondary outcome [16] 0 0
Predose Plasma Concentration (Ctrough) of Avelumab
Timepoint [16] 0 0
Pre-dose (0 hour) on Day 1 of Cycle 1, 2, 3, 5, 7, 9, 11, 13 and Day 15 of Cycle 1, 2, 3 (each cycle=28 days)
Secondary outcome [17] 0 0
Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
Timepoint [17] 0 0
From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
Secondary outcome [18] 0 0
Number of ADA Ever Positive Participants For Each Serum of ADA Titers for Avelumab
Timepoint [18] 0 0
From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
Secondary outcome [19] 0 0
Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never Positive and Ever Positive Status
Timepoint [19] 0 0
From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
Secondary outcome [20] 0 0
Number of Participants With Programmed Death Receptor-1 Ligand 1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
Timepoint [20] 0 0
Up to 41 months at the time of the analysis
Secondary outcome [21] 0 0
Number of Participants With Cluster of Differentiation 8 (CD8) T Lymphocytes (Cytotoxic T Lymphocytes)
Timepoint [21] 0 0
Up to approximately 60 months
Secondary outcome [22] 0 0
Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Score at Day 1 of Cycle 6
Timepoint [22] 0 0
Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
Secondary outcome [23] 0 0
Time to Deterioration (TTD) Based on National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores
Timepoint [23] 0 0
From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months)
Secondary outcome [24] 0 0
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score at Cycle 6
Timepoint [24] 0 0
Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
Secondary outcome [25] 0 0
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) - Visual Analog Scale (VAS) Score at Cycle 6
Timepoint [25] 0 0
Baseline, Day 1 of Cycle 6 (1 cycle=28 days)

Eligibility
Key inclusion criteria
* Histologically confirmed, unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium
* Stage IV disease at the start of first-line chemotherapy
* Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy
* Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin
* No evidence of progressive disease following completion of first-line chemotherapy (i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
* Prior immunotherapy with IL-2, IFN-a, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however, alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse events not constituting a safety risk based on the investigator's judgement are acceptable.
* Patients with known symptomatic central nervous system (CNS) metastases requiring steroids
* Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/03/2023
Sample size
Target
Accrual to date
Final
700
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [4] 0 0
Ramsay Pharmacy - Kogarah
Recruitment hospital [5] 0 0
St George Private Hospital - Kogarah
Recruitment hospital [6] 0 0
Epic Pharmacy - Lismore
Recruitment hospital [7] 0 0
North Coast Radiology St Vincents - Lismore
Recruitment hospital [8] 0 0
Northern Rivers Pathology Service - Lismore
Recruitment hospital [9] 0 0
St Vincent's Pathology Lismore - Lismore
Recruitment hospital [10] 0 0
Macquarie Medical Imaging - Macquarie University
Recruitment hospital [11] 0 0
Macquarie University Hospital Pharmacy - Macquarie University
Recruitment hospital [12] 0 0
Macquarie University - Macquarie University
Recruitment hospital [13] 0 0
The Murwillumbah Hospital - Murwillubah
Recruitment hospital [14] 0 0
The Tweed Hospital Pharmacy Department - Tweed Heads
Recruitment hospital [15] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [16] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [17] 0 0
River City Pharmacy - Auchenflower
Recruitment hospital [18] 0 0
Oncology Pharmacy - Birtinya
Recruitment hospital [19] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [20] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [21] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [22] 0 0
Slade Health - Geebung
Recruitment hospital [23] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [24] 0 0
Icon Cancer Care - South Brisbane
Recruitment hospital [25] 0 0
Integrated Clinical Oncology Network (ICON) Corporate Office - South Brisbane
Recruitment hospital [26] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [27] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [28] 0 0
SA Pharmacy, Level 3 Pharmacy - Bedford Park
Recruitment hospital [29] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [30] 0 0
Ashford Cancer Centre Research - Kurralta park
Recruitment hospital [31] 0 0
Cancer Care SA Pty Ltd - Kurralta Park
Recruitment hospital [32] 0 0
Icon Cancer Care SA trading as Icon Pharmacy Adelaide - Kurralta Park
Recruitment hospital [33] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [34] 0 0
BHS Diagnostic Services - Ballarat
Recruitment hospital [35] 0 0
Lake Imaging - Ballarat
Recruitment hospital [36] 0 0
Ballarat Oncology & Haematology Services - Ballarat
Recruitment hospital [37] 0 0
Box Hill Hospital - Pharmacy Department, Bulding B, Loading Dock (access via Thames St) - Box Hill
Recruitment hospital [38] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [39] 0 0
Eastern Health Clinical School - Box Hill
Recruitment hospital [40] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [41] 0 0
Monash Medical Centre - East Bentleigh
Recruitment hospital [42] 0 0
Moorabbin Radiology - East Bentleigh
Recruitment hospital [43] 0 0
Ballarat Day Procedure Centre - Wendouree
Recruitment hospital [44] 0 0
Ballarat Oncology & Haematology Services - Wendouree
Recruitment hospital [45] 0 0
Nova Pharmacy - Wendouree
Recruitment hospital [46] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [47] 0 0
St John of God Murdoch Hospital - Murdoch
Recruitment hospital [48] 0 0
Slade Health - Mount Waverley
Recruitment hospital [49] 0 0
Macquarie Heart - New South Wales
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2830 - Dubbo
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2480 - Lismore
Recruitment postcode(s) [6] 0 0
2109 - Macquarie University
Recruitment postcode(s) [7] 0 0
2484 - Murwillubah
Recruitment postcode(s) [8] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [9] 0 0
4066 - Auchenflower
Recruitment postcode(s) [10] 0 0
4575 - Birtinya
Recruitment postcode(s) [11] 0 0
4032 - Chermside
Recruitment postcode(s) [12] 0 0
4814 - Douglas
Recruitment postcode(s) [13] 0 0
4034 - Geebung
Recruitment postcode(s) [14] 0 0
4101 - South Brisbane
Recruitment postcode(s) [15] 0 0
4215 - Southport
Recruitment postcode(s) [16] 0 0
5042 - Bedford Park
Recruitment postcode(s) [17] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [18] 0 0
5037 - Kurralta park
Recruitment postcode(s) [19] 0 0
5011 - Woodville South
Recruitment postcode(s) [20] 0 0
3350 - Ballarat
Recruitment postcode(s) [21] 0 0
3355 - Ballarat
Recruitment postcode(s) [22] 0 0
3128 - Box Hill
Recruitment postcode(s) [23] 0 0
3168 - Clayton
Recruitment postcode(s) [24] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [25] 0 0
3355 - Wendouree
Recruitment postcode(s) [26] 0 0
6150 - Murdoch
Recruitment postcode(s) [27] 0 0
3149 - Mount Waverley
Recruitment postcode(s) [28] 0 0
2109 - New South Wales
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
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Caba
Country [10] 0 0
Argentina
State/province [10] 0 0
La Rioja
Country [11] 0 0
Belgium
State/province [11] 0 0
Brasschaat
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
Belgium
State/province [15] 0 0
Ghent
Country [16] 0 0
Belgium
State/province [16] 0 0
Kortrijk
Country [17] 0 0
Belgium
State/province [17] 0 0
Liège
Country [18] 0 0
Belgium
State/province [18] 0 0
Wilrijk
Country [19] 0 0
Brazil
State/province [19] 0 0
BA
Country [20] 0 0
Brazil
State/province [20] 0 0
RIO Grande DO SUL
Country [21] 0 0
Brazil
State/province [21] 0 0
RJ
Country [22] 0 0
Brazil
State/province [22] 0 0
RS
Country [23] 0 0
Brazil
State/province [23] 0 0
SP
Country [24] 0 0
Brazil
State/province [24] 0 0
São Paulo
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Czechia
State/province [27] 0 0
Ceska Republika
Country [28] 0 0
Czechia
State/province [28] 0 0
Brno
Country [29] 0 0
Czechia
State/province [29] 0 0
Horovice
Country [30] 0 0
Denmark
State/province [30] 0 0
Aalborg
Country [31] 0 0
Denmark
State/province [31] 0 0
Aarhus C
Country [32] 0 0
Denmark
State/province [32] 0 0
Aarhus N
Country [33] 0 0
Denmark
State/province [33] 0 0
Copenhagen OE
Country [34] 0 0
Denmark
State/province [34] 0 0
Herlev
Country [35] 0 0
Denmark
State/province [35] 0 0
København Ø
Country [36] 0 0
Denmark
State/province [36] 0 0
Odense C
Country [37] 0 0
Denmark
State/province [37] 0 0
Odense
Country [38] 0 0
France
State/province [38] 0 0
Cedex 13
Country [39] 0 0
France
State/province [39] 0 0
Angers Cedex 02
Country [40] 0 0
France
State/province [40] 0 0
Angers
Country [41] 0 0
France
State/province [41] 0 0
Bayonne
Country [42] 0 0
France
State/province [42] 0 0
BESANCON cedex
Country [43] 0 0
France
State/province [43] 0 0
Besançon
Country [44] 0 0
France
State/province [44] 0 0
CRÉTEIL Cedex
Country [45] 0 0
France
State/province [45] 0 0
Hyères
Country [46] 0 0
France
State/province [46] 0 0
Le Mans
Country [47] 0 0
France
State/province [47] 0 0
Lille cedex
Country [48] 0 0
France
State/province [48] 0 0
Lille
Country [49] 0 0
France
State/province [49] 0 0
Lyon cedex 8
Country [50] 0 0
France
State/province [50] 0 0
LYON cedex 8
Country [51] 0 0
France
State/province [51] 0 0
Marseille cedex 5
Country [52] 0 0
France
State/province [52] 0 0
Marseille Cedex 9
Country [53] 0 0
France
State/province [53] 0 0
Marseille
Country [54] 0 0
France
State/province [54] 0 0
Nimes Cedex 9
Country [55] 0 0
France
State/province [55] 0 0
Nimes
Country [56] 0 0
France
State/province [56] 0 0
PARIS cedex 13
Country [57] 0 0
France
State/province [57] 0 0
Paris
Country [58] 0 0
France
State/province [58] 0 0
Rennes Cedex
Country [59] 0 0
France
State/province [59] 0 0
Rouen Cedex 1
Country [60] 0 0
France
State/province [60] 0 0
Rouen
Country [61] 0 0
France
State/province [61] 0 0
Saint Herblain Cedex
Country [62] 0 0
France
State/province [62] 0 0
Strasbourg
Country [63] 0 0
France
State/province [63] 0 0
Suresnes
Country [64] 0 0
France
State/province [64] 0 0
Villejuif cedex
Country [65] 0 0
France
State/province [65] 0 0
Villejuif
Country [66] 0 0
Greece
State/province [66] 0 0
Athens
Country [67] 0 0
Greece
State/province [67] 0 0
PC
Country [68] 0 0
Greece
State/province [68] 0 0
Patra
Country [69] 0 0
Greece
State/province [69] 0 0
Thessaloniki
Country [70] 0 0
Hong Kong
State/province [70] 0 0
Hong Kong
Country [71] 0 0
Hungary
State/province [71] 0 0
Kaposvár
Country [72] 0 0
India
State/province [72] 0 0
Delhi
Country [73] 0 0
India
State/province [73] 0 0
Gujarat
Country [74] 0 0
India
State/province [74] 0 0
Maharashtra
Country [75] 0 0
India
State/province [75] 0 0
Telangana
Country [76] 0 0
India
State/province [76] 0 0
WEST Bengal
Country [77] 0 0
Israel
State/province [77] 0 0
Jerusalem
Country [78] 0 0
Israel
State/province [78] 0 0
Ramat - GAN
Country [79] 0 0
Israel
State/province [79] 0 0
Beer Yaakov
Country [80] 0 0
Israel
State/province [80] 0 0
Haifa
Country [81] 0 0
Israel
State/province [81] 0 0
Ramat - Gan
Country [82] 0 0
Italy
State/province [82] 0 0
(torino)
Country [83] 0 0
Italy
State/province [83] 0 0
Ancona
Country [84] 0 0
Italy
State/province [84] 0 0
Forli-cesena
Country [85] 0 0
Italy
State/province [85] 0 0
Genoa
Country [86] 0 0
Italy
State/province [86] 0 0
Liguria
Country [87] 0 0
Italy
State/province [87] 0 0
Milan
Country [88] 0 0
Italy
State/province [88] 0 0
Ravenna
Country [89] 0 0
Italy
State/province [89] 0 0
Torino
Country [90] 0 0
Italy
State/province [90] 0 0
Arezzo
Country [91] 0 0
Italy
State/province [91] 0 0
Aviano (PN)
Country [92] 0 0
Italy
State/province [92] 0 0
Bologna
Country [93] 0 0
Italy
State/province [93] 0 0
Naples
Country [94] 0 0
Italy
State/province [94] 0 0
Napoli
Country [95] 0 0
Italy
State/province [95] 0 0
Pisa
Country [96] 0 0
Italy
State/province [96] 0 0
Rome
Country [97] 0 0
Italy
State/province [97] 0 0
Terni
Country [98] 0 0
Japan
State/province [98] 0 0
Aichi
Country [99] 0 0
Japan
State/province [99] 0 0
Aomori
Country [100] 0 0
Japan
State/province [100] 0 0
Ehime
Country [101] 0 0
Japan
State/province [101] 0 0
Gunma
Country [102] 0 0
Japan
State/province [102] 0 0
Hokkaido
Country [103] 0 0
Japan
State/province [103] 0 0
Hyogo
Country [104] 0 0
Japan
State/province [104] 0 0
Ibaraki
Country [105] 0 0
Japan
State/province [105] 0 0
Iwate
Country [106] 0 0
Japan
State/province [106] 0 0
Kanagawa
Country [107] 0 0
Japan
State/province [107] 0 0
Osaka
Country [108] 0 0
Japan
State/province [108] 0 0
Saitama
Country [109] 0 0
Japan
State/province [109] 0 0
Shizuoka
Country [110] 0 0
Japan
State/province [110] 0 0
Tokyo
Country [111] 0 0
Japan
State/province [111] 0 0
Yamaguchi
Country [112] 0 0
Japan
State/province [112] 0 0
Chiba
Country [113] 0 0
Japan
State/province [113] 0 0
Fukuoka
Country [114] 0 0
Japan
State/province [114] 0 0
Hiroshima
Country [115] 0 0
Japan
State/province [115] 0 0
Kagoshima
Country [116] 0 0
Japan
State/province [116] 0 0
Kumamoto
Country [117] 0 0
Japan
State/province [117] 0 0
Niigata
Country [118] 0 0
Japan
State/province [118] 0 0
Tokushima
Country [119] 0 0
Japan
State/province [119] 0 0
Yamagata
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Gyeonggi-do
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Gyeonggido
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Daejeon
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Seoul
Country [124] 0 0
Mexico
State/province [124] 0 0
Ciudad DE Mexico
Country [125] 0 0
Mexico
State/province [125] 0 0
Estado DE Mexico
Country [126] 0 0
Mexico
State/province [126] 0 0
Guanajuato
Country [127] 0 0
Netherlands
State/province [127] 0 0
Arnhem
Country [128] 0 0
Netherlands
State/province [128] 0 0
Haarlem
Country [129] 0 0
Netherlands
State/province [129] 0 0
Hoofddorp
Country [130] 0 0
Netherlands
State/province [130] 0 0
Maastricht
Country [131] 0 0
Netherlands
State/province [131] 0 0
Nijmegen
Country [132] 0 0
New Zealand
State/province [132] 0 0
Auckland
Country [133] 0 0
New Zealand
State/province [133] 0 0
Auckalnd
Country [134] 0 0
New Zealand
State/province [134] 0 0
Christchurch
Country [135] 0 0
New Zealand
State/province [135] 0 0
Hamilton
Country [136] 0 0
Norway
State/province [136] 0 0
Lorenskog
Country [137] 0 0
Norway
State/province [137] 0 0
Nordbyhagen
Country [138] 0 0
Norway
State/province [138] 0 0
Stavanger
Country [139] 0 0
Poland
State/province [139] 0 0
Masovian
Country [140] 0 0
Poland
State/province [140] 0 0
Lublin
Country [141] 0 0
Poland
State/province [141] 0 0
Torun
Country [142] 0 0
Portugal
State/province [142] 0 0
Coimbra
Country [143] 0 0
Portugal
State/province [143] 0 0
Lisboa
Country [144] 0 0
Portugal
State/province [144] 0 0
Porto
Country [145] 0 0
Portugal
State/province [145] 0 0
Senhora da Hora
Country [146] 0 0
Portugal
State/province [146] 0 0
Vila Real
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Bashkortostan Republic
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Kaluzhskaya Region
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Saint Petersburg
Country [150] 0 0
Russian Federation
State/province [150] 0 0
Moscow
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Omsk
Country [152] 0 0
Russian Federation
State/province [152] 0 0
St. Petersburg
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Yaroslavl
Country [154] 0 0
Serbia
State/province [154] 0 0
Belgrade
Country [155] 0 0
Serbia
State/province [155] 0 0
Nis
Country [156] 0 0
Serbia
State/province [156] 0 0
Sremska Kamenica
Country [157] 0 0
Spain
State/province [157] 0 0
A Coruña
Country [158] 0 0
Spain
State/province [158] 0 0
Alicante
Country [159] 0 0
Spain
State/province [159] 0 0
Asturias
Country [160] 0 0
Spain
State/province [160] 0 0
Barcelona
Country [161] 0 0
Spain
State/province [161] 0 0
Comunidad Valenciana
Country [162] 0 0
Spain
State/province [162] 0 0
Galicia
Country [163] 0 0
Spain
State/province [163] 0 0
Madrid
Country [164] 0 0
Spain
State/province [164] 0 0
Navarra
Country [165] 0 0
Spain
State/province [165] 0 0
Badajoz
Country [166] 0 0
Spain
State/province [166] 0 0
Cordoba
Country [167] 0 0
Spain
State/province [167] 0 0
Gerona
Country [168] 0 0
Spain
State/province [168] 0 0
Lugo
Country [169] 0 0
Spain
State/province [169] 0 0
Sevilla
Country [170] 0 0
Spain
State/province [170] 0 0
Valencia
Country [171] 0 0
Sweden
State/province [171] 0 0
Stockholm
Country [172] 0 0
Taiwan
State/province [172] 0 0
Taichung
Country [173] 0 0
Taiwan
State/province [173] 0 0
Tainan
Country [174] 0 0
Taiwan
State/province [174] 0 0
Taipei
Country [175] 0 0
Taiwan
State/province [175] 0 0
Taoyuan
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Bath
Country [177] 0 0
United Kingdom
State/province [177] 0 0
London
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Oxford

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


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/NCT02603432