Status:
COMPLETED
Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Meningitis, Meningococcal, Serogroup B
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis. This ...
Detailed Description
Meningococcal disease is a contagious bacterial disease caused by Neisseria meningitidis that can kill children and young adults very quickly. Meningococci are divided into distinct sergroups based on...
Eligibility Criteria
Inclusion
- Healthy military or civilian males or non-pregnant, non-lactating females
- Age 18-45
- Give informed consent and understand risk and benefit of study
- Understands and willing to comply with all protocol procedures and time commitment
- FEMALES only: surgically sterilized or received a negative pregnancy test on day of first injection AND agrees to practice adequate birth control, if necessary, for the next 7 months after first vaccination.
Exclusion
- Currently has or has had a history of significant organ/system disease
- History of allergy to any vaccine
- Allergy to component of vaccine such as aluminum hydroxide
- Presence of significant unexplained laboratory abnormality
- HIV sero-positive or any other immunosuppressive state
- Positive test for HBsAg, or hepatitis C
- Ongoing drug abuse/dependence
- Received any live vaccine, experimental products or immunosuppressive therapy in the last 28 days or inactivated vaccine in the past 14 days, or received parenteral immunoglobulin or blood products within the past 3 months
- Intention to leave study area for an extended period of time during the study
- Females: positive urine pregnancy test prior to vaccination
Key Trial Info
Start Date :
December 5 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00248833
Start Date
December 5 2005
End Date
December 1 2007
Last Update
October 29 2018
Active Locations (1)
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1
Walter Reed Army Institute of Research, Clinical Trials Center
Silver Spring, Maryland, United States, 20910