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 - ND

• Conditions: Prevention Meningitis/Sepsi caused by Meningococcus type B or A, C, W-135, Y; MedDRA version: 9.1Level: SOCClassification code 10021881Term: Infections and infestations

• Registration Number: EUCTR2007-001563-29-IT
• Lead Sponsor: OVARTIS VACCINES AND DIAGNOSTICS S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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). The criteria from number 6 to number 16 are reported in the Protocol.

Study & Design

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