Trial conducted in more then one site to assess safety of the Novartis vaccine against meningititis B injected at 0 and after 2 months in adults at risk because managing meningoccocus type B or travelling in geographic area where Meningitis B is highly present

• Conditions: Healthy volunteers (Meningitis B); MedDRA version: 14.1Level: PTClassification code 10027249Term: Meningitis meningococcalSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-003694-29-IT
• Lead Sponsor: OVARTIS VACCINES AND DIAGNOSTICS S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-20
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. 18 – 60 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 and/or are travelling to geographical areas considered at high risk for epidemic Meningococcal B infection disease.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature = 38°C|100.4ºF) within the previous day; 2.Antibiotics within 3 days (72 hours) prior to enrollment; 3. Pregnancy or nursing (breastfeeding) mothers; 4. Females who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device 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 for at least 30 days prior to study entry; 5.Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 6.Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants; 7.History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component; 8.Any condition which in the opinion of the investigator may interfere with evaluation of the study objectives.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA