A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults

Phase 3

Completed

• Conditions: Meningococcal Disease; Meningococcal Meningitis
• Interventions: Biological: Recombinant meningococcal B + OMV NZ

• Registration Number: NCT01478347
• Lead Sponsor: Novartis Vaccines

Brief Summary

The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).

In the second part of the study additional blood samples of high responding vaccinated subjects will be collected for the purpose of generating a control serum panel for the human serum bactericidal assay (hSBA) tests.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-23
• Study Start: 2013-05
• Primary Completion: 2014-03
• Study Completion: 2014-11
• Results First Submitted: 2015-02-20
• Results First Submitted QC: 2015-02-20
• Status Verified: 2015-03
• Results First Posted: 2015-03-06
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rMenB+OMV NZ	Recombinant meningococcal B + OMV NZ	Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant meningococcal B (rMenB) + Outer Membrane Vesicle (OMV NZ) vaccine, 2 months apart, in part I of the study, were enrolled for optional blood draws and safety follow-up in part II of the study.

Primary Outcome Measures

Name	Time	Method
Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study).	Day 92 to day 331	The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include - AEs considered to be related to blood draw procedure and all SAEs.
Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91.	Day 1 to day 91	The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.

Trial Locations

Locations (1)

UOC Medicina Interna 2, Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, Italy