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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00808028 |
The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.
Condition | Intervention | Phase |
---|---|---|
Meningitis, Meningococcal |
Biological: meningococcal B rLP2086 vaccine. Other: normal saline (placebo) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B rLP2086 Vaccine at Doses of 60 Mcg, 120 Mcg, and 200 Mcg in Healthy Adolescents Aged 11 to 18 Years |
Estimated Enrollment: | 715 |
Study Start Date: | September 2009 |
Estimated Study Completion Date: | March 2014 |
Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
dose level 1 rLP2086 vaccine
|
Biological: meningococcal B rLP2086 vaccine. |
2: Experimental
dose level 2 rLP2086 vaccine
|
Biological: meningococcal B rLP2086 vaccine. |
3: Experimental
dose level 3 rLP2086 vaccine
|
Biological: meningococcal B rLP2086 vaccine. |
4: Placebo Comparator
normal saline (placebo)
|
Other: normal saline (placebo) |
Ages Eligible for Study: | 11 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion Criteria:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 6108A1-2001 |
Study First Received: | December 12, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00808028 |
Health Authority: | Australia: Human Research Ethics Committee |
Bacterial Infections Central Nervous System Infections Meningococcal Infections Meningitis, Bacterial Meningitis, Meningococcal Central Nervous System Diseases |
Healthy Meningococcal infection Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |
Nervous System Diseases Central Nervous System Bacterial Infections |