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.

Novartis

Status and phase: Completed; Phase 3

Conditions: Prevention of the Meningococcal Disease

Treatments: Biological: rMenB+OMV NZ

Study type: Interventional

Funder types: Industry

Identifiers

NCT01911221

V72_59

2012-005815-25 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Sponsor's employees are considered eligible to participate in the trial as per inclusion criteria.

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);

4. Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an exclusion criteria;

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

rMenB+OMV NZ

Experimental group

Description:

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

Treatment:

Biological: rMenB+OMV NZ