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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01478347
First received: November 21, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 portion 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.


Condition Intervention Phase
Meningococcal Disease
Meningococcal Meningitis
Biological: Recombinant meningococcal B + OMV NZ
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 3b, Single-Center, Open-label Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-risk Adults

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of subjects exposed to study vaccines with reported serious adverse events (SAEs) and/or adverse events (AEs) [ Time Frame: from day 1 to day 90 ] [ Designated as safety issue: Yes ]
    To descriptively assess the safety of Novartis rMenB+OMV NZ in healthy at-risk adults when administered at a 0,2- month schedule, throughout the clinical study.


Enrollment: 18
Study Start Date: May 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
rMenB+OMV NZ
Biological: Recombinant meningococcal B + OMV NZ
2 dose 2 months apart

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment;
  2. Able to comprehend and follow all required study procedures;
  3. 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);
  4. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
  5. Who were or might be routinely exposed to N. meningitidis cultures

Inclusion criteria for protocol part 2

  1. 18 - 65 years of age inclusive;
  2. At least 50 kg weight;
  3. Blood pressure within the following ranges: Systolic 110-180; Diastolic 60-100;
  4. Regular pulse rate (50-90 beats per minute) - exceptions are acceptable upon investigator's judgment;
  5. Hematocrit higher than: 32% for women and 35% for males;
  6. Visit 3 sera suitable as control for standardization of the SBA as confirmed by the central laboratory.

Exclusion criteria:

  1. History of any serogroup B meningococcal vaccine administration
  2. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
  3. Pregnancy or nursing (breastfeeding) mothers;
  4. 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;
  5. 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
  6. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
  7. 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.
  8. Any significant chronic infection.
  9. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

Exclusion criteria for protocol part 2:

  1. Known or suspected autoimmune disease;
  2. 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);
  3. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
  4. History of fainting or seizure episodes;
  5. Pregnancy;
  6. Any significant chronic infection.
  7. Significant acute infections within the previous 2 weeks or body temperature >38.0C within the previous 2 weeks.
  8. 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
  9. Significant acute illness within the previous 7 days or body temperature >38.0C within the previous 3 days.
  10. Receipt of systemic antibiotics within the previous 3 days (72 hours).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478347

Locations
Italy
UOC Medicina Interna 2, Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01478347     History of Changes
Other Study ID Numbers: V72_37
Study First Received: November 21, 2011
Last Updated: April 2, 2014
Health Authority: EMA: European Medicinal Agency

Keywords provided by Novartis:
Neisseria, Meningitis, Group B, Vaccine, At-risk, Adults

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on April 16, 2014