Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02305446|
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : November 2, 2015
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Meningitis, Meningococcal, Serogroup B||Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3b, Open Label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults From 18 to 50 Years of Age and to Collect Blood Donations to Develop Vaccines Against Neisseria Meningitidis|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: rMenB+OMV NZ
Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
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.
Other Name: rMenB+OMV NZ
- Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67) ]Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.
- Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test. [ Time Frame: Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2. ]The number of identified healthy adult volunteers with pre and postvaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305446
|01, Novartis Investigational Site|