Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination
NCT ID: NCT00889889
Last Updated: 2013-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1270 participants
INTERVENTIONAL
2009-05-31
2011-01-31
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
QUADRUPLE
Study Groups
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1
Cell-Derived Trivalent Subunit Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
2
Placebo
Placebo
Interventions
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Cell-Derived Trivalent Subunit Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Men and women aged \>= 18 and \<= 64 years.
3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria
2. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
3. Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.
18 Years
64 Years
ALL
Yes
Sponsors
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Quintiles, Inc.
INDUSTRY
Abbott Biologicals
INDUSTRY
Responsible Party
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Principal Investigators
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Hanka de Voogd, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 45690
Jacksonville, Florida, United States
Site Reference ID/Investigator# 45687
Pembroke Pines, Florida, United States
Site Reference ID/Investigator# 45697
South Miami, Florida, United States
Site Reference ID/Investigator# 45691
Lenexa, Kansas, United States
Site Reference ID/Investigator# 45689
Overland Park, Kansas, United States
Site Reference ID/Investigator# 45694
Wichita, Kansas, United States
Site Reference ID/Investigator# 45682
Lexington, Kentucky, United States
Site Reference ID/Investigator# 45684
Kansas City, Missouri, United States
Site Reference ID/Investigator# 45685
Omaha, Nebraska, United States
Site Reference ID/Investigator# 45686
Las Vegas, Nevada, United States
Site Reference ID/Investigator# 45688
Raleigh, North Carolina, United States
Site Reference ID/Investigator# 45696
Nashville, Tennessee, United States
Site Reference ID/Investigator# 45683
Austin, Texas, United States
Site Reference ID/Investigator# 45695
Fort Worth, Texas, United States
Site Reference ID/Investigator# 45692
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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S203.2.004
Identifier Type: -
Identifier Source: org_study_id
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