A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

Individuals eligible to be enrolled into this study are those:
1.male and female adults 18 through 50 years of age at enrollment;
2.able to comprehend and follow all required study procedures;
3.who have given written consent after the nature of the study has been explained;
4.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);
5.in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
6.who are or may be routinely exposed to N. meningitidis cultures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Individuals not eligible to be enrolled into this study are those who:
1.have had household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
2.have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (defined as axillary temperature = 38°C) within the previous day;
3.have received antibiotics within 6 days prior to enrollment;
4.are pregnant or nursing (breastfeeding) mothers or females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 8-month duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device 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 two months prior to study entry;
5.suffer from any serious chronic or progressive disease (e.g., any history of neoplasm, insulin dependent diabetes, cardiovascular disease, hepatic disease, renal disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, signs of cardiac or renal failure or severe malnutrition). Subjects who suffer from metabolic syndrome with more than 2 criteria fulfilled and/or not sufficiently controlled diseases as part of the metabolic syndrome will have to be excluded. (exception: subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring chronic use of inhaled or systemic corticosteroids are not eligible for enrollment);
6.have any other serious chronic disease including progressive neurological disease or seizure disorder;
7.have a known or suspected impairment/alteration of the immune system, resulting from:
·receipt of immunosuppressive therapy, including use of corticosteroids 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];
·receipt of immunostimulants
8.have an inherited genetic anomaly (known cytogenic disorders, e.g., Down's Syndrome);
9.have received blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
10.have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
11.have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component;
12.have either received, or for whom there is intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period (exception: licensed flu-vaccine should not be administered within 14 days prior to enrollment);
13.are obese at screening (e.g., with a body mass index [BMI] = 30 where BMI reflects obesity and not high muscle mass);
14.have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study;
15.have a current problem or a history of substance abuse which, in the opinion of the investigator or medical monitor, might interfere with

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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