Overview

This trial is active, not recruiting.

Conditions meningococcal disease, meningococcal meningitis
Treatment recombinant meningococcal b + omv nz
Phase phase 3
Sponsor Novartis Vaccines
Start date May 2013
End date March 2014
Trial size 18 participants
Trial identifier NCT01478347, V72_37

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
rMenB+OMV NZ
recombinant meningococcal b + omv nz
2 dose 2 months apart

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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).

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Novartis.