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.

NCT ID: NCT01911221

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-04-30

Brief Summary

The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).

Conditions

Prevention of the Meningococcal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

rMenB+OMV NZ

A single 0.5mL dose of the study vaccine will be administered intramuscularly in the deltoid muscle.

Group Type: EXPERIMENTAL

rMenB+OMV NZ

Intervention Type: BIOLOGICAL

Recombinant MenB with Outer Member Vesicle (OMV) from the New Zealand strain

Interventions

rMenB+OMV NZ

Recombinant MenB with Outer Member Vesicle (OMV) from the New Zealand strain

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 18 - 65 years of age inclusive who 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 medical history, physical examination and clinical judgment of the investigator;

4. Who are or might be routinely exposed to cultures of N. meningitidis serogroup B.

Exclusion Criteria

1. Pregnancy or nursing (breastfeeding) mothers;

2. 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;

3. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);

5. History of any serogroup B meningococcal vaccine administration;

6. Previous known or suspected disease caused by N. meningitidis;

7. History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine;

8. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):

• Receipt of any chronic immunosuppressive therapy
• Receipt of any chronic immunostimulants
• Immune deficiency disorder, or known HIV infection

9. Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study;

10. 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;

11. Any significant chronic infection;

12. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;

13. Family members and household members of research staff;

14. Participation in another clinical trial within the last 30 days or planned for during study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines and Diagnostics

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Novartis site

Marburg, , Germany

Countries

Germany

Other Identifiers

2012-005815-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V72_59

Identifier Type: -

Identifier Source: org_study_id