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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03090191
Registration number
NCT03090191
Ethics application status
Date submitted
20/03/2017
Date registered
24/03/2017
Titles & IDs
Public title
Clostridium Difficile Vaccine Efficacy Trial
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Scientific title
A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER
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Secondary ID [1]
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2016-003866-14
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Secondary ID [2]
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B5091007
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Universal Trial Number (UTN)
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Trial acronym
Clover
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clostridium Difficile Infection
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Condition category
Condition code
Infection
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Clostridium difficile vaccine
Treatment: Other - Placebo
Experimental: Clostridium difficile vaccine -
Placebo comparator: Placebo -
Treatment: Other: Clostridium difficile vaccine
Toxoid-based Clostridium difficile vaccine
Treatment: Other: Placebo
Normal saline solution (0.9% sodium chloride)
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 3
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Assessment method [1]
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CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by polymerase chain reaction \[PCR)\] and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
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Timepoint [1]
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From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
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Primary outcome [2]
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Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 2
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Assessment method [2]
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CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
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Timepoint [2]
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From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
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Primary outcome [3]
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Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1
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Assessment method [3]
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Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (\>) 5.0 to 10.0 cm, severe: \>10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
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Timepoint [3]
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Within 7 days after Dose 1 at Month 0
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Primary outcome [4]
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Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2
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Assessment method [4]
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Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \>10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
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Timepoint [4]
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Within 7 days after Dose 2 at Month 1
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Primary outcome [5]
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Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3
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Assessment method [5]
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Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \>10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
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Timepoint [5]
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Within 7 days after Dose 3 at Month 6
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Primary outcome [6]
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Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1
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Assessment method [6]
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Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 degree Celsius \[deg C\]), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (\> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
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Timepoint [6]
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Within 7 days after Dose 1 at Month 0
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Primary outcome [7]
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Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2
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Assessment method [7]
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Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (\> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
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Timepoint [7]
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Within 7 days after Dose 2 at Month 1
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Primary outcome [8]
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Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3
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Assessment method [8]
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Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (\> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
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Timepoint [8]
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Within 7 days after Dose 3 at Month 6
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Primary outcome [9]
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Number of Participants Reporting Adverse Events (AEs)
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Assessment method [9]
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An AE was defined as any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and all non-serious adverse events. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event. AEs included both SAEs and all Non-SAEs (except local and systemic events).
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Timepoint [9]
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From Day 1 of Dose 1 to 1 Month after Dose 3 (7 Months)
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Primary outcome [10]
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Number of Participants Reporting Serious Adverse Events (SAEs)
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Assessment method [10]
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An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
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Timepoint [10]
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From Day 1 of Dose 1 up to 6 months after Dose 3 (up to Month 12)
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Secondary outcome [1]
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Number of All Episodes of CDI (Definition 1 and 2) After Dose 3
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Assessment method [1]
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CDI definition 1 for primary episode of CDI (no previous CDI onset in prior 8 weeks) and CDI definition 2 for recurrent episode (episode occurred 8 weeks or less after onset of previous episode \[provided symptoms of previous episode resolved\]) were both defined as either a) presence of diarrhea, (passage of 3 or more unformed stools \[Bristol stool chart types 5-7\]) in 24 or fewer consecutive hours, stool sample positive for toxin B gene (by PCR),positive for toxin A and/or toxin B, as measured in central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, surgery, histopathologically; and corresponding stool sample positive for toxin B gene (via PCR) as measured in central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
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Timepoint [1]
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From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
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Secondary outcome [2]
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Time to Resolution for Participants With First Primary Episodes of CDI (Definition 1) After Dose 3
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Assessment method [2]
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Resolution of the event was the last day on which the event was recorded in the e-diary or the date the event ends if it was unresolved during the participant diary-recording period (end date collected on the case report form \[CRF\]). CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
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Timepoint [2]
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From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
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Secondary outcome [3]
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Proportion of Participants Who Required Medical Attention During First Primary Episode of CDI (Definition 1) After Dose 3
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Assessment method [3]
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CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
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Timepoint [3]
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From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
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Secondary outcome [4]
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Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 3
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Assessment method [4]
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CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode \[provided the symptoms of the previous episode had resolved\]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
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Timepoint [4]
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From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
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Secondary outcome [5]
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Number of All Episodes of CDI (Definition 1 and 2) After Dose 2
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Assessment method [5]
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CDI definition 1 for primary episode of CDI (no previous CDI onset in prior 8 weeks) and CDI definition 2 for recurrent episode (episode occurred 8 weeks or less after onset of previous episode \[provided symptoms of previous episode resolved\]) were both defined as either a) presence of diarrhea, (passage of 3 or more unformed stools \[Bristol stool chart types 5-7\]) in 24 or fewer consecutive hours, stool sample positive for toxin B gene (by PCR),positive for toxin A and/or toxin B, as measured in central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, surgery, histopathologically; and corresponding stool sample positive for toxin B gene (via PCR) as measured in central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
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Timepoint [5]
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From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
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Secondary outcome [6]
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Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 2
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Assessment method [6]
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CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode \[provided the symptoms of the previous episode had resolved\]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
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Timepoint [6]
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From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
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Secondary outcome [7]
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Number of First Primary Episode of CDI (Definition 1) After Dose 2 and Before Dose 3
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Assessment method [7]
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CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
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Timepoint [7]
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From 14 days after Dose 2 to Dose 3 or the day the third vaccination was expected (168 days after Dose 2) for participants who received only 2 doses
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Secondary outcome [8]
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Number of Participants With Recurrent Episode of CDI (Definition 2) After Dose 2 and Before Dose 3
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Assessment method [8]
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CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode \[provided the symptoms of the previous episode had resolved\]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
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Timepoint [8]
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From 14 days after Dose 2 to Dose 3 or the day the third vaccination was expected (168 days after Dose 2) for participants who received only 2 doses
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Eligibility
Key inclusion criteria
* Evidence of a personally signed and dated informed consent document.
* Willing and able to comply with study procedures.
* Subjects with an increased risk of future contact with healthcare systems or subjects who have received systemic antibiotics in the previous 12 weeks.
* Ability to be contacted by telephone during study participation.
* Negative urine pregnancy test for female subjects of childbearing potential.
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
* Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination.
* Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
* Prior episode of CDI..
* Receipt of blood products or immunoglobulins within 6 months before enrollment.
* Subjects who may be unable to respond to vaccination due to:
* Metastatic malignancy; or
* End-stage renal disease; or
* Any serious medical disorder likely to be fatal within the next 12 months; or
* Congenital or acquired immunodeficiency; or
* Receipt of high dose systemic corticosteroids for 14 days within 28 days of enrollment; or
* Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
* Known infection with human immunodeficiency virus (HIV).
* Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
* Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
* Prior small- or large-bowel resection.
* Any condition or treatment resulting in frequent diarrhea.
* Other acute or chronic condition or abnormality that may increase the risk associated with study participation or IP administration or may interfere with interpretation of study results
* Pregnant or breastfeeding female subjects; male subjects and female subjects who are sexually active and at risk for pregnancy and will not/cannot use 2 methods of contraception
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/12/2021
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Sample size
Target
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Accrual to date
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Final
17535
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Paratus Clinical Pty Ltd - Kanwal
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Recruitment hospital [2]
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Australian Clinical Research Network - Maroiubra
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Recruitment hospital [3]
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Maroubra Medical Centre - Maroubra
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Recruitment hospital [4]
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University Clinic Pharmacy - Westmead
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Recruitment hospital [5]
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Westmead Hospital - Westmead
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Recruitment hospital [6]
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Austrials Pty Ltd - Sherwood
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Recruitment hospital [7]
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Mater Misericordiae Ltd & Mater Medical Research Institute Ltd - South Brisbane
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Recruitment hospital [8]
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Eastern Health - Box Hill Hospital - Box Hill
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Recruitment hospital [9]
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Emeritus Research - Camberwell
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Recruitment hospital [10]
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Barwon Health - Geelong
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Recruitment hospital [11]
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Linear Clinical Research - Nedlands
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Recruitment hospital [12]
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Australian Clinical Research Network - Maroubra
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Recruitment postcode(s) [1]
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2259 - Kanwal
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Recruitment postcode(s) [2]
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2035 - Maroiubra
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Recruitment postcode(s) [3]
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2035 - Maroubra
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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4075 - Sherwood
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Recruitment postcode(s) [6]
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4101 - South Brisbane
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Recruitment postcode(s) [7]
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3128 - Box Hill
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Recruitment postcode(s) [8]
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3124 - Camberwell
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Recruitment postcode(s) [9]
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3220 - Geelong
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Recruitment postcode(s) [10]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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State/province [7]
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Florida
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0
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State/province [8]
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Georgia
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Country [9]
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State/province [9]
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Hawaii
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0
0
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Michigan
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Minnesota
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Mississippi
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Missouri
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Montana
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Nebraska
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New Jersey
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New Mexico
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New York
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Country [27]
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0
United States of America
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State/province [27]
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North Carolina
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0
0
United States of America
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State/province [28]
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North Dakota
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0
United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Oregon
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Country [32]
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0
United States of America
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State/province [32]
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Pennsylvania
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United States of America
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State/province [33]
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Rhode Island
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United States of America
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State/province [34]
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South Carolina
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Country [35]
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0
United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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0
United States of America
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Washington
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0
United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Santa FE
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Country [43]
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Argentina
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Cordoba
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Belgium
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Brussels
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Belgium
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Leuven
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Belgium
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Liege
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Bulgaria
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Kazanlak
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Bulgaria
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Kozloduy
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Bulgaria
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State/province [49]
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Lom
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Country [50]
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Bulgaria
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State/province [50]
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Pleven
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Country [51]
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sevlievo
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Bulgaria
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Silistra
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Bulgaria
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Sliven
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Bulgaria
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Sofia
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Bulgaria
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Troyan
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Bulgaria
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Veliko Tarnovo
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Bulgaria
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Vidin
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Country [63]
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Chile
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IX Region DE LA Araucania
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Country [64]
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Chile
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State/province [64]
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Region DE Antofagasta
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Chile
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State/province [65]
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Region DE LA Araucania
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Chile
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Región Metropolitana
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Country [67]
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Colombia
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State/province [67]
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Antioquia
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Colombia
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Atlantico
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Country [69]
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Colombia
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Caldas
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Colombia
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D.c.
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Colombia
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Quindío
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Colombia
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State/province [72]
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Santander
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Colombia
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State/province [73]
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Valle DEL Cauca
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Czechia
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Czech
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Czechia
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State/province [75]
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Benatky nad Jizerou
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Czechia
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Kyjov
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Czechia
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Opava
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Country [78]
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Czechia
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State/province [78]
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Policka
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Country [79]
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Czechia
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State/province [79]
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Praha 5
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Country [80]
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Czechia
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State/province [80]
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Pribram I.
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Country [81]
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Czechia
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State/province [81]
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Roznov pod Radhostem
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Country [82]
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0
Czechia
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State/province [82]
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Slany
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Country [83]
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Czechia
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State/province [83]
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Usti nad Labem
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Country [84]
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Finland
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State/province [84]
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Helsinki
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Country [85]
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Finland
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State/province [85]
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Kokkola
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Country [86]
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Finland
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State/province [86]
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Oulu
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Country [87]
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0
Finland
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Pori
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Country [88]
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Finland
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Tampere
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Country [89]
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Finland
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Turku
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France
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Dijon cedex
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France
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Paris
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France
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State/province [92]
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Saint Priest en Jarez
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France
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State/province [93]
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Tours Cedex 09
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Germany
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Berlin
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Germany
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Cottbus
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Germany
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State/province [96]
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Dresden
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0
Germany
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State/province [97]
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Essen
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Country [98]
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Germany
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State/province [98]
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Leipzig
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Country [99]
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Germany
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Rostock
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Country [100]
0
0
Germany
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Westerstede
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Germany
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State/province [101]
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Wuerzburg
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Country [102]
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Hungary
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State/province [102]
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Baja
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Country [103]
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Hungary
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Balatonfured
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Country [104]
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Hungary
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Budapest
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Country [105]
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0
Hungary
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State/province [105]
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Debrecen
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Country [106]
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Hungary
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State/province [106]
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Encs
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Country [107]
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Hungary
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Kaposvar
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Country [108]
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Japan
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State/province [108]
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Aichi
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Country [109]
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Japan
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State/province [109]
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Fukuoka
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Country [110]
0
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Japan
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State/province [110]
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0
Hiroshima
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Country [111]
0
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Japan
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State/province [111]
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Hokkaido
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Country [112]
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Japan
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State/province [112]
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Ibaraki
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Country [113]
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Japan
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State/province [113]
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Kanagawa
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Country [114]
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Japan
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State/province [114]
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Miyagi
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Country [115]
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Japan
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State/province [115]
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Nagano Prefecture
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Country [116]
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0
Japan
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State/province [116]
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Osaka
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Country [117]
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Japan
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Shiga
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Country [118]
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Japan
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State/province [118]
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Shizuoka
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Country [119]
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Japan
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State/province [119]
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Tokyo
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Country [120]
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Japan
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State/province [120]
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Fukui
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Country [121]
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Japan
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State/province [121]
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Kumamoto
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Country [122]
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0
Japan
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State/province [122]
0
0
Saga
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Country [123]
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0
Korea, Republic of
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State/province [123]
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Gangwon-do
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Country [124]
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0
Korea, Republic of
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State/province [124]
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Gyeonggi-do
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Korea, Republic of
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0
Seoul
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Korea, Republic of
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Busan
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Korea, Republic of
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State/province [127]
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Daegu
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Country [128]
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0
Korea, Republic of
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State/province [128]
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Incheon
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Country [129]
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Peru
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State/province [129]
0
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Lima
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Country [130]
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Peru
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Cusco
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Country [131]
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Peru
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Trujillo, La Libertad
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Country [132]
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Poland
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State/province [132]
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Bydgoszcz
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Poland
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State/province [133]
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Gdansk
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Poland
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Gdynia
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Poland
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State/province [135]
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Katowice
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Country [136]
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0
Poland
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State/province [136]
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Leczna
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Poland
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Poznan
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Country [138]
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Poland
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Warszawa
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Country [139]
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Poland
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State/province [139]
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Wroclaw
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Country [140]
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Portugal
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State/province [140]
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0
Almada
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Country [141]
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0
Portugal
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State/province [141]
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Aveiro
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Country [142]
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Portugal
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Braga
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Country [143]
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Portugal
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Guimaraes
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Country [144]
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Portugal
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State/province [144]
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Vila Nova de Gaia
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Slovakia
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State/province [145]
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Bojnice
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Country [146]
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Slovakia
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State/province [146]
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Bratislava
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Country [147]
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Slovakia
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State/province [147]
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Kosice
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Country [148]
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Slovakia
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State/province [148]
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Nitra
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Country [149]
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Slovakia
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State/province [149]
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Nove Zamky
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Country [150]
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Slovakia
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State/province [150]
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0
Piestany
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Country [151]
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Slovakia
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State/province [151]
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Pruske
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Country [152]
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Slovakia
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State/province [152]
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Rimavska Sobota
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Country [153]
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Slovakia
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State/province [153]
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Spisska Nova Ves
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Slovakia
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State/province [154]
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Stara Tura
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Slovakia
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Trencin
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Country [156]
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Slovakia
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Trnava
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Country [157]
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Spain
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Barcelona
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Country [158]
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Spain
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State/province [158]
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A Coruna
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Country [159]
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Spain
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Madrid
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Country [160]
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Spain
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State/province [160]
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Sevilla
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Country [161]
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Spain
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Valencia
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Country [162]
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Sweden
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State/province [162]
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Eskilstuna
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Country [163]
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Sweden
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State/province [163]
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Goteborg
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Country [164]
0
0
Sweden
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State/province [164]
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Göteborg
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Sweden
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Orebro
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Country [166]
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Sweden
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Stockholm
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Country [167]
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0
Taiwan
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Taiwan (r.o.c.)
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Country [168]
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Taiwan
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New Taipei City
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Taiwan
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Taipei
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Country [170]
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United Kingdom
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Cheshire
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Country [171]
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United Kingdom
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Cornwall
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Country [172]
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United Kingdom
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Devon
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United Kingdom
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Lancashire
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Country [174]
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United Kingdom
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Leicestershire
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Country [175]
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United Kingdom
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Midlothian
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Country [176]
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United Kingdom
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State/province [176]
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0
WEST Midlands
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Country [177]
0
0
United Kingdom
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State/province [177]
0
0
Leeds
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Country [178]
0
0
United Kingdom
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State/province [178]
0
0
Newcastle upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03090191
Query!
Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
Query!
Email
0
0
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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
Query!
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.
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/91/NCT03090191/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/91/NCT03090191/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03090191