Status:
COMPLETED
Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
Lead Sponsor:
Novartis
Conditions:
Meningitis, Meningococcal, Serogroup B
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
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 im...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT02305446
Start Date
December 1 2014
End Date
April 1 2015
Last Update
January 5 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
01, Novartis Investigational Site
Krakow, Poland