Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents
NCT ID: NCT00297817
Last Updated: 2016-12-01
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
203 participants
INTERVENTIONAL
2006-02-28
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Arm 1: rMenB
serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
Arm 2: rMenB + OMV
serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
Arm 3: Placebo
serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.
Interventions
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serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
11 Years
18 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines - Drug Information Services
Role: STUDY_CHAIR
Novartis
Locations
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Encinitas, California, United States
Atlanta, Georgia, United States
St Louis, Missouri, United States
Cleveland, Ohio, United States
Galveston, Texas, United States
Layton, Utah, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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V72P3
Identifier Type: -
Identifier Source: org_study_id