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.

Phase 3CompletedNCT01911221

Novartis Vaccines13 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Prevention of the Meningococcal Disease

Interventions

rMenB+OMV NZBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Novartis site

Marburg, Germany

Outcomes

Primary Outcomes

Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule

The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination.

Time frame: Day1 and Day 91

Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule

The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline.

Time frame: Day1 and Day 91

Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.

The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.

Time frame: Day1 and Day91

Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.

The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.

Time frame: Day1 and Day91

Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.

The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.

Data from ClinicalTrials.gov

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