A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adults Aged 18 to 65 Years inclusive.

• Conditions: A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adults Aged 18 to 65 Years inclusive.; MedDRA version: 14.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-005815-25-DE
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-17
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

18 – 65 years of age inclusive who have given written informed consent at the time of enrollment;
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);
In good health as determined by medical history, physical examination and clinical judgment of the investigator;
Who are or might be routinely exposed to cultures of N. meningitidis serogroup B.
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy or nursing (breastfeeding) mothers;
Females of reproductive age 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 60 days prior to study entry;
Any serious chronic or progressive disease according to judgment of the investigator;
Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an exclusion criteria;
History of any serogroup B meningococcal vaccine administration;
Previous known or suspected disease caused by N. meningitidis;
History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine;
Known or suspected autoimmune disease or impairment/alteration of the immune system;
Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study;
History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
Any significant chronic infection;
Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
Family members and household members of research staff;
Participation in another clinical trial within the last 30 days or planned for during
study.

Study & Design

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