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

NCT01478347 | Completed Phase 3 Results

• 1 other identifier: V72_37
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningococcal Disease; Meningococcal Meningitis

Keywords

Neisseria, Meningitis, Group B, Vaccine, At-risk, Adults

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through 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.

  Day 1 to day 91

• 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).

  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.

  Day 92 to day 331

Study Arms (1)

rMenB+OMV NZ

EXPERIMENTAL

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.

Biological: Recombinant meningococcal B + OMV NZ

Interventions

Recombinant meningococcal B + OMV NZ BIOLOGICAL

2 injections 2 months apart

rMenB+OMV NZ

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age inclusive who have given written informed consent at the time of enrollment;
• Able to comprehend and follow all required study procedures;
• Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
• In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
• Who were or might be routinely exposed to N. meningitidis cultures
• years of age inclusive;
• At least 50 kg weight;
• Blood pressure within the following ranges: Systolic 110-180; Diastolic 60-100;
• Regular pulse rate (50-90 beats per minute) - exceptions are acceptable upon investigator's judgment;
• Hematocrit higher than: 32% for women and 35% for males;
• Visit 3 sera suitable as control for standardization of the SBA as confirmed by the central laboratory.

You may not qualify if:

• History of any serogroup B meningococcal vaccine administration
• History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
• Pregnancy or nursing (breastfeeding) mothers;
• Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least one months prior to study entry;
• Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
• Receipt of any chronic immunosuppressive therapy
• Receipt of any chronic immunostimulants
• Immune deficiency disorder, or known HIV infection
• Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
• History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study.
• Any significant chronic infection.
• Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
• Known or suspected autoimmune disease;
• Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, diabetes, cardiovascular, renal, hepatic, immunological, metabolic, urogenital, hematological, gastrointestinal, central nervous system disease);
• Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;

Sponsors & Collaborators

• Novartis Vaccines: lead
• Novartis: collaborator

Study Sites (1)

UOC Medicina Interna 2, Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal; Meningitis

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 27, 2015
• Results First Posted: March 6, 2015

Record last verified: 2015-03

Locations

IT (1)