NCT02305446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 2, 2015

Completed
Last Updated

January 5, 2016

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

November 20, 2014

Results QC Date

October 1, 2015

Last Update Submit

December 3, 2015

Conditions

Meningitis, Meningococcal, Serogroup B

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (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.

Study Arms (1)

rMenB+OMV NZ

EXPERIMENTAL

Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Interventions

Meningococcal (group B) multicomponent recombinant adsorbed vaccineBIOLOGICAL

One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.

Also known as: rMenB+OMV NZ
rMenB+OMV NZ

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

01, Novartis Investigational Site

Krakow, Poland

Location

Related Publications (1)

  • 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.

    PMID: 28580917DERIVED

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMeningococcal InfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Results Point of Contact

Title
Posting Director
Organization
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2014

First Posted

December 2, 2014

Study Start

December 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 5, 2016

Results First Posted

November 2, 2015

Record last verified: 2015-12

Locations

PL(1)