Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.

Phase 3

Completed

• Conditions: Meningitis, Meningococcal, Serogroup B
• Interventions: Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine

• Registration Number: NCT02305446
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-26
• Study Start: 2014-12
• Study First Posted: 2014-12-02
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2015-10-01
• Results First Submitted QC: 2015-10-01
• Results First Posted: 2015-11-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Individuals of 18 through 50 years of age on the day of informed consent;
2. 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;
3. Individuals who could comply with study procedures including follow-up;
4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method.

Exclusion Criteria

1. Progressive, unstable or uncontrolled clinical conditions;

2. Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study;

3. Abnormal function of the immune system;

4. Chronic clinical significant conditions;

5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rMenB+OMV NZ	Meningococcal (group B) multicomponent recombinant adsorbed vaccine	Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Unsolicited Adverse Events (AEs).	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.

Trial Locations

Locations (1)

01, Novartis Investigational Site; 🇵🇱 Krakow, Poland