Clinical trial NCT01911221: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention of the Meningococcal Disease
Keywords: Meningococcal disease,
Adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2013-07-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


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.

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.

Primary outcomes:
measure: Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
timeFrame: Day1 and Day 91
measure: Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
timeFrame: Day1 and Day 91
measure: Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
timeFrame: Day1 and Day91
measure: Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
timeFrame: Day1 and Day91
measure: 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.
timeFrame: Day 91
measure: Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule
timeFrame: Day 1 and Day 91
measure: Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.
timeFrame: Day 1 and Day 91
measure: Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.
timeFrame: Day 1 and Day 91
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
timeFrame: Day 1 through Day 7 postvaccination.
measure: Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
timeFrame: Day 1 through Day 91 postvaccination.
measure: Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
timeFrame: Day 1 through Day 91 postvaccination.
Secondary outcomes:
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Novartis site
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References: