Study Evaluating the Safety and Immunogenicity of Novartis rMenB+OMV NZ Vaccine Formulated with Outer Membrane Vesicle (OMV) Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

• Conditions: Prophylaxis against invasive meningococcal disease; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004476-30-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-24
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. 11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment;
2. 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);
3. in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Are the trial subjects under 18? yes
Number of subjects for this age range: 344
F.1.2 Adults (18-64 years) no
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

1. History of any serogroup B meningococcal vaccine administration;
2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
4. Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature = 38.0 °C) within the previous day;
5. Antibiotics within 3 days (72 hours) prior to enrollment;
6. Pregnancy or nursing (breastfeeding) mothers;
7. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 2 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;
8. 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).
9. 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;
10. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
11. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
12. Receipt of or intent to immunize with any other vaccine(s) within 30 days prior (60 days for live viral vaccines) and throughout the study period (exception: licensed flu-vaccine should not be administered within 14 days prior to enrollment; routine vaccine may be administered after the blood draw at the last study visit);
13. Participation in another clinical trial within the last 90 days or planned for during study;
14. Family members and household members of research staff;
15. Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives

Study & Design

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