A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis M… (NCT01911221) | Clinical Trial Compass
CompletedPhase 3
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.
Germany13 participantsStarted 2013-08
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
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 (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
✕. 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;
What they're measuring
1
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
Timeframe: Day1 and Day 91
2
Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
Timeframe: Day1 and Day 91
3
Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
Timeframe: Day1 and Day91
4
Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
Timeframe: Day1 and Day91
5
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
6
Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule
Timeframe: Day 1 and Day 91
7
Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.