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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
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
Secondary ID [1] 0 0
2016-003866-14
Secondary ID [2] 0 0
B5091007
Universal Trial Number (UTN)
Trial acronym
Clover
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clostridium Difficile Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 3
Timepoint [1] 0 0
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Primary outcome [2] 0 0
Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 2
Timepoint [2] 0 0
From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
Primary outcome [3] 0 0
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1
Timepoint [3] 0 0
Within 7 days after Dose 1 at Month 0
Primary outcome [4] 0 0
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2
Timepoint [4] 0 0
Within 7 days after Dose 2 at Month 1
Primary outcome [5] 0 0
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3
Timepoint [5] 0 0
Within 7 days after Dose 3 at Month 6
Primary outcome [6] 0 0
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1
Timepoint [6] 0 0
Within 7 days after Dose 1 at Month 0
Primary outcome [7] 0 0
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2
Timepoint [7] 0 0
Within 7 days after Dose 2 at Month 1
Primary outcome [8] 0 0
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3
Timepoint [8] 0 0
Within 7 days after Dose 3 at Month 6
Primary outcome [9] 0 0
Number of Participants Reporting Adverse Events (AEs)
Timepoint [9] 0 0
From Day 1 of Dose 1 to 1 Month after Dose 3 (7 Months)
Primary outcome [10] 0 0
Number of Participants Reporting Serious Adverse Events (SAEs)
Timepoint [10] 0 0
From Day 1 of Dose 1 up to 6 months after Dose 3 (up to Month 12)
Secondary outcome [1] 0 0
Number of All Episodes of CDI (Definition 1 and 2) After Dose 3
Timepoint [1] 0 0
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Secondary outcome [2] 0 0
Time to Resolution for Participants With First Primary Episodes of CDI (Definition 1) After Dose 3
Timepoint [2] 0 0
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Secondary outcome [3] 0 0
Proportion of Participants Who Required Medical Attention During First Primary Episode of CDI (Definition 1) After Dose 3
Timepoint [3] 0 0
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Secondary outcome [4] 0 0
Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 3
Timepoint [4] 0 0
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Secondary outcome [5] 0 0
Number of All Episodes of CDI (Definition 1 and 2) After Dose 2
Timepoint [5] 0 0
From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
Secondary outcome [6] 0 0
Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 2
Timepoint [6] 0 0
From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
Secondary outcome [7] 0 0
Number of First Primary Episode of CDI (Definition 1) After Dose 2 and Before Dose 3
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Number of Participants With Recurrent Episode of CDI (Definition 2) After Dose 2 and Before Dose 3
Timepoint [8] 0 0
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

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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2021
Sample size
Target
Accrual to date
Final
17535
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Pty Ltd - Kanwal
Recruitment hospital [2] 0 0
Australian Clinical Research Network - Maroiubra
Recruitment hospital [3] 0 0
Maroubra Medical Centre - Maroubra
Recruitment hospital [4] 0 0
University Clinic Pharmacy - Westmead
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Austrials Pty Ltd - Sherwood
Recruitment hospital [7] 0 0
Mater Misericordiae Ltd & Mater Medical Research Institute Ltd - South Brisbane
Recruitment hospital [8] 0 0
Eastern Health - Box Hill Hospital - Box Hill
Recruitment hospital [9] 0 0
Emeritus Research - Camberwell
Recruitment hospital [10] 0 0
Barwon Health - Geelong
Recruitment hospital [11] 0 0
Linear Clinical Research - Nedlands
Recruitment hospital [12] 0 0
Australian Clinical Research Network - Maroubra
Recruitment postcode(s) [1] 0 0
2259 - Kanwal
Recruitment postcode(s) [2] 0 0
2035 - Maroiubra
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4075 - Sherwood
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3124 - Camberwell
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Leeds
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United Kingdom
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Newcastle upon Tyne

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
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 are available at https://clinicaltrials.gov/study/NCT03090191