Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
NCT02305446 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2016-01-05
Summary
The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.
Conditions
- Meningitis, Meningococcal, Serogroup B
Interventions
- BIOLOGICAL
-
Meningococcal (group B) multicomponent recombinant adsorbed vaccine
One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2015-04-30
- Completion
- 2015-04-30
Countries
- Poland
Study Locations
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