A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
NCT ID: NCT02117570
Last Updated: 2017-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2014-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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High dose of C. difficile vaccine
Clostridium difficile vaccine
0.5 mL intramuscular injection on day 1, day 8, and day 30.
Low dose of C. difficile vaccine
Clostridium difficile vaccine
0.5 mL intramuscular injection on day 1, day 8, and day 30.
Placebo
Placebo
Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.
Interventions
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Clostridium difficile vaccine
0.5 mL intramuscular injection on day 1, day 8, and day 30.
Clostridium difficile vaccine
0.5 mL intramuscular injection on day 1, day 8, and day 30.
Placebo
Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.
Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
50 Years
85 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Avail Clinical Research, LLC
DeLand, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Meridian Clinical Research
Norfolk, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, United States
PMG Research of Charlotte
Charlotte, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Benchmark Research
Austin, Texas, United States
Benchmark Research
San Angelo, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Countries
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Related Links
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Other Identifiers
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2013-004764-58
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B5091003
Identifier Type: -
Identifier Source: org_study_id
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