Status:
COMPLETED
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
Lead Sponsor:
Pfizer
Conditions:
Meningitis, Meningococcal
Eligibility:
All Genders
11-18 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Healthy male or female subjects between the ages of \>=11 and \<=18 years at the time of enrollment.
- Negative urine pregnancy test for all female subjects.
- Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion
- History of any invasive meningococcal disease.
- A previous anaphylactic or severe vaccine-associated adverse reaction.
- Any clinically significant chronic disease.
- A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
- Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT00808028
Start Date
February 1 2009
End Date
March 1 2014
Last Update
April 14 2015
Active Locations (27)
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1
Queensland Paediatric Infectious Diseases (QPID) Laboratory
Herston, Queensland, Australia, 4029
2
Department of Paediatrics, Women's & Children's Hospital
North Adelaide, South Australia, Australia, 5006
3
Royal Children's Hospital
Carlton, Victoria, Australia, 3053
4
Children's Clinical Research Facility, Vaccine Trials Group (VTG),
Subiaco, Western Australia, Australia, 6008