Back to resultsSafety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
Primary Purpose
Meningitis, Meningococcal, Serogroup B
Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningitis, Meningococcal, Serogroup B
Eligibility Criteria
Inclusion Criteria:
- Individuals of 18 through 50 years of age on the day of informed consent;
- Individuals who had voluntarily given written informed consent after the nature of the study had been explained according to local regulatory requirements, prior to study entry;
- Individuals who could comply with study procedures including follow-up;
- Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method.
Exclusion Criteria:
- Progressive, unstable or uncontrolled clinical conditions;
- Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study;
- Abnormal function of the immune system;
- Chronic clinical significant conditions;
4. Been administered any group B meningococcal vaccine at any time prior to informed consent; 5. Current or previous, confirmed or suspected disease caused by N.meningitidis.
Sites / Locations
- 01, Novartis Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rMenB+OMV NZ
Arm Description
Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Outcomes
Primary Outcome Measures
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02305446
Brief Title
Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
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 Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal, Serogroup B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rMenB+OMV NZ
Arm Type
Experimental
Arm Description
Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Intervention Type
Biological
Intervention Name(s)
Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Other Intervention Name(s)
rMenB+OMV NZ
Intervention Description
One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Description
Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.
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)
Other Pre-specified Outcome Measures:
Title
Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals of 18 through 50 years of age on the day of informed consent;
Individuals who had voluntarily given written informed consent after the nature of the study had been explained according to local regulatory requirements, prior to study entry;
Individuals who could comply with study procedures including follow-up;
Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method.
Exclusion Criteria:
Progressive, unstable or uncontrolled clinical conditions;
Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study;
Abnormal function of the immune system;
Chronic clinical significant conditions;
4. Been administered any group B meningococcal vaccine at any time prior to informed consent; 5. Current or previous, confirmed or suspected disease caused by N.meningitidis.
Facility Information:
Facility Name
01, Novartis Investigational Site
City
Krakow
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28580917
Citation
Maritan M, Cozzi R, Lo Surdo P, Veggi D, Bottomley MJ, Malito E. Crystal structures of human Fabs targeting the Bexsero meningococcal vaccine antigen NHBA. Acta Crystallogr F Struct Biol Commun. 2017 Jun 1;73(Pt 6):305-314. doi: 10.1107/S2053230X17006021. Epub 2017 May 11.
Results Reference
derived
Learn more about this trial
Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
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