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

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

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.

Study Overview

• Status: Completed
• Conditions: Meningitis, Meningococcal, Serogroup B
• Intervention / Treatment: Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland
    • 01, Novartis Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: rMenB+OMV NZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Reporting Unsolicited Adverse Events (AEs).	Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.	From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.	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.	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.

Collaborators and Investigators

• Sponsor: Novartis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 20, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (Estimate): December 2, 2014

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis
• Other Study ID Numbers: V72_74; 2014-002972-95 (EudraCT Number)